Skip to content

Nivolumab

  • Antibody medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Nivolumab does in the body

Used for several advanced cancers by helping immune cells attack tumours.

T cells have an off-switch called PD-1 that healthy tissue uses to say "not me". Tumours copy that signal to shut down the attack. Nivolumab plugs the switch so the tumour cannot send the message. It is the same idea as pembrolizumab, from a different company, discovered in parallel.

What happened in people

In untreated advanced melanoma, half the group taking both medicines went 11.5 months before worsening, versus 2.9 months with ipilimumab alone.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

The combination causes far more severe side effects, and many people stop treatment.

Where it acts
Tumour microenvironment and tumour-draining lymph nodes
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · 31YO63LBSN · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

The limit a reviewer approved as the one that matters most here.

The four opening statements run to 85 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Results from the one trial this record names

  • In NCT01642004, Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (primary outcome measure): median overall survival in months, reported with a 95% confidence interval was Nivolumab: 9.23 (7.33 to 13.27) against Docetaxel: 6.01 (5.13 to 7.33) in the comparison group at Randomization until 199 deaths, up to November 2014, approximately 25 months.

    ClinicalTrials.gov record · NCT01642004 · read 2026-08-28

Progression-free survival and overall survival in untreated advanced melanoma

The study showed what it set out to show

Who was studied
CheckMate 067 (NCT01844505)
How many people
945
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
p < 0.001; HR 0.42 (99.5% CI 0.31-0.57) for combination versus ipilimumab
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Grade 3-4 treatment-related events were markedly more frequent in the combination arm than in either monotherapy arm.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous infusion, 30 minutes

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Progression-free survival in first-line NSCLC with PD-L1 expression of 5% or more (423 patients analysed)

The study did not show it

Who was studied
CheckMate 026 (NCT02041533)
How many people
541
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
p = 0.25; HR 1.15 (95% CI 0.91-1.45)
Repeated elsewhere
Failed to Replicate

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous infusion, 30 minutes

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 2 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.9 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.2 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

Where a source records it acting

  • Immune and lymphatic system: Binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response

    US prescribing information · f570b9c4-6846-4de2-abfa-4d0a4ae4e394 · read 2026-08-28

  1. Start

    Nivolumab

    What a person takes: Intravenous infusion, 30 minutes.

    The measurement behind this step

    Flat-dose infusion of 240 mg every 2 weeks or 480 mg every 4 weeks. A subcutaneous co-formulation with hyaluronidase was approved separately in December 2024.

  2. Getting in

    Intravenous infusion at fixed dose

    Given as a drip over about half an hour, every two, three or four weeks depending on the regimen.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Flat dosing of 240 mg every 2 weeks or 480 mg every 4 weeks, with linear pharmacokinetics, a central volume near 3.6 L and a terminal half-life around 25 days.

  3. Reaching the cell

    Penetration into tumour and lymphoid tissue

    It leaks out of the leaky vessels that tumours build and accumulates where PD-1-bearing T cells sit.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Interstitial delivery by convection, with target-mediated binding on PD-1-high tumour-infiltrating lymphocytes producing measurable receptor occupancy above 70% at clinical doses.

  4. What it acts on

    Occupying PD-1 on the T cell surface

    The antibody sits over the off-switch, so neither of the tumour signals that would flip it can dock.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Binds the PD-1 IgV domain, blocking both PD-L1 and PD-L2. The IgG4 S228P backbone minimises Fc effector function so that PD-1-expressing lymphocytes are not depleted by the antibody that is meant to reactivate them.

  5. The change it makes

    Inhibitory phosphatase recruitment stops

    The chemical brake inside the T cell is no longer applied, and the machinery that had been shut down restarts.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Unligated PD-1 does not recruit SHP-1 and SHP-2 to its ITIM and ITSM motifs, so CD28 and ZAP-70 remain phosphorylated, PI3K-AKT signalling proceeds, and effector gene transcription resumes.

  6. What that does for a person

    Cytotoxic attack and long-lived memory

    Reactivated T cells kill tumour cells and some persist as memory cells, which is why a minority of patients stay in remission long after treatment ends.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Clonal expansion of tumour-reactive CD8 T cells with granzyme and perforin release, interferon-gamma-driven antigen presentation upregulation, and epitope spreading to additional tumour antigens.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • pharmacokinetic serum concentration of pegilodecakin
  • maximum observed plasma concentration

Meaningful

Things that change how a life goes, not only a number.

  • deaths
  • time to relapse
  • progression free survival
  • overall survival
  • overall survival rate
  • rate of progression free survival
  • 2 year overall survival
  • incidence of death
  • phase 2 progression free survival

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (29)
  • an adverse event
  • serious adverse event
  • best overall response rate
  • that experienced drug related grade 3 4 aes
  • that experienced drug related grade 3 4 saes
  • adverse events
  • serious adverse events
  • adverse events leading to discontinuation
  • who died
  • laboratory abnormalities in specific liver tests
  • laboratory abnormalities in specific thyroid tests
  • objective response rate
  • cr rate
  • objective response
  • teaes and saes observed during the study of pegilodecakin
  • incidence of dose limiting toxicities
  • incidence of adverse events
  • incidence of serious adverse events
  • clinical response rate
  • overall response rate

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 25 days

    Read from the label, which states: “The geometric mean elimination half-life (t 1/2 ) is 25 days (77.5%).”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults with advanced disease across a dozen tumour types, alone or combined with ipilimumab, chemotherapy or relatlimab depending on indication.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

Who a named study recorded including and excluding

  • NCT01642004 recorded its participants as: Minimum age 18 years; all sexes eligible, as recorded in the registry eligibility module.

    ClinicalTrials.gov record · NCT01642004 · read 2026-08-28

  • It included: Men and women ≥18 years of age; Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease); Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease; Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

    ClinicalTrials.gov record · NCT01642004 · read 2026-08-28

  • It excluded: Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment.; Subjects with carcinomatous meningitis; Subjects with active, known or suspected autoimmune disease; Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody; Prior treatment with Docetaxel; Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.

    ClinicalTrials.gov record · NCT01642004 · read 2026-08-28

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of OPDIVO have not been established for pediatric patients younger than 12 years old with melanoma, MSI-H or dMMR mCRC, or cHL.”

    US prescribing information · f570b9c4-6846-4de2-abfa-4d0a4ae4e394 · read 2026-08-30

  • On older people, the label states: “In patients with cHL, recurrent head and neck SCC, or dMMR or MSI-H metastatic CRC (mCRC) who were treated with single agent OPDIVO in clinical studies did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients [see Clinical Studies (14.8 , 14.9 , 14.11) ].”

    US prescribing information · f570b9c4-6846-4de2-abfa-4d0a4ae4e394 · read 2026-08-30

  • On people who are pregnant, the label states: “The effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis through delivery, at exposure levels of between 9 and 42 times higher than those observed at the clinical dose of 3 mg/kg (based on AUC).”

    US prescribing information · f570b9c4-6846-4de2-abfa-4d0a4ae4e394 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of nivolumab in human milk, the effects on the breastfed child, or the effects on milk production.”

    US prescribing information · f570b9c4-6846-4de2-abfa-4d0a4ae4e394 · read 2026-08-30

Where the result stopped carrying

  • CheckMate 026 missed its primary progression-free survival endpoint in first-line PD-L1-positive lung cancer
  • Single-agent activity in microsatellite-stable colorectal cancer, prostate cancer and glioblastoma has been minimal
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Given by a clinician

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Intravenous infusion, 30 minutes

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S3, S4.

No source is stored against this line.

What is in the pack

Flat-dose infusion of 240 mg every 2 weeks or 480 mg every 4 weeks. A subcutaneous co-formulation with hyaluronidase was approved separately in December 2024.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatological reactions and myocarditis all carry label warnings. Toxicity is substantially higher when combined with ipilimumab.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Nivolumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9998 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • malignant neoplasm progression — 2832 reaction mentions
  • colitis — 1466 reaction mentions
  • pneumonitis — 1250 reaction mentions
  • hypothyroidism — 1089 reaction mentions
  • adrenal insufficiency — 694 reaction mentions
  • hepatitis — 608 reaction mentions
  • hypophysitis — 568 reaction mentions
  • hyperthyroidism — 553 reaction mentions
  • tubulointerstitial nephritis — 479 reaction mentions
  • immune-mediated enterocolitis — 459 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Intravenous infusion, 30 minutes

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

A subcutaneous co-formulation with hyaluronidase was approved separately in December 2024.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 12 products list this as an active ingredient in the United States drug directory. 9 of them contain it and nothing else.

    FDA National Drug Code directory · 0003-3120 · read 2026-08-29

  • They are sold as injection, injection, solution and liquid, taken intravenous and subcutaneous.

    FDA National Drug Code directory · 0003-3120 · read 2026-08-29

  • The regulator's established pharmacologic class for it is programmed death receptor-1 blocking antibody [epc] and programmed death receptor-1-directed antibody interactions [moa].

    FDA National Drug Code directory · 0003-3120 · read 2026-08-29

  • 2 published labels name it as an active ingredient. None of them describes this substance alone, so no label text on this page can be attributed to it rather than to a combination.

    US prescribing information · 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b · read 2026-08-29

  • Opdivo is injection: solution in a single-dose vial for intravenous use at 40 mg/4 mL (10 mg/mL), 100 mg/10 mL (10 mg/mL), 120 mg/12 mL (10 mg/mL), and 240 mg/24 mL (10 mg/mL) solution in a single-dose vial, recorded as prescription product; fda label in effect 2026-05-12 in the United States.

    US prescribing information · f570b9c4-6846-4de2-abfa-4d0a4ae4e394 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Nivolumab studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That the nivolumab-ipilimumab combination is proven superior to nivolumab alone; CheckMate 067 was not powered for that comparison

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That failure of CheckMate 026 proves nivolumab is inferior to pembrolizumab first-line; the trials used different PD-L1 thresholds and assays and were never compared directly

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Nivolumab are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

CheckMate 067: combination therapy gave 11.5 months progression-free survival against 2.9
In plain words
In 945 people with untreated advanced melanoma, nivolumab plus ipilimumab held the disease at bay for a median of 11.5 months compared with 2.9 months on ipilimumab alone.
What was measured
Median progression-free survival 11.5 versus 2.9 months, HR 0.42
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, three-arm phase 3. Median progression-free survival was 11.5 months (95% CI 8.9-16.7) for the combination versus 6.9 months for nivolumab alone and 2.9 months (95% CI 2.8-3.4) for ipilimumab alone; hazard ratio for the combination versus ipilimumab was 0.42 (99.5% CI 0.31-0.57). The trial was not powered for a formal combination-versus-nivolumab comparison.
Source
Larkin et al., New England Journal of Medicine 2015 (CheckMate 067, NCT01844505)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
CheckMate 026: first-line nivolumab in PD-L1-positive lung cancer missed its endpoint
In plain words
The trial designed to make nivolumab the first treatment for advanced lung cancer failed. Progression-free survival was numerically worse than chemotherapy, and survival was no better.
What was measured
Median progression-free survival 4.2 versus 5.9 months, HR 1.15, primary endpoint not met
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Open-label phase 3, 541 randomised, primary analysis in the 423 patients with PD-L1 expression of 5% or more. Median progression-free survival 4.2 months with nivolumab versus 5.9 months with platinum chemotherapy (hazard ratio 1.15, 95% CI 0.91-1.45, p = 0.25); median overall survival 14.4 versus 13.2 months (HR 1.02). The contemporaneous KEYNOTE-024 succeeded using a 50% PD-L1 threshold and a different assay, which is the standard explanation but was not tested prospectively.
Source
Carbone et al., New England Journal of Medicine 2017 (CheckMate 026, NCT02041533)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The biomarker threshold, not the drug, decided two nearly identical lung cancer trials
In plain words
Two anti-PD-1 antibodies were tested first-line in lung cancer within a year of each other. One succeeded, one failed. The most cited difference is where each trial drew the PD-L1 cut-off, which is a design choice rather than a property of either molecule.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CheckMate 026 enrolled at a 5% tumour PD-L1 threshold using the Dako 28-8 assay; KEYNOTE-024 enrolled at 50% using the Dako 22C3 assay. The field concluded that the enrolled populations differed rather than the drugs, and subsequent first-line development moved to combination regimens with chemotherapy or ipilimumab. This reading is plausible and widely held but rests on cross-trial comparison, which is not evidence of equivalence.
Source
Comparison of CheckMate 026 (NCT02041533) and KEYNOTE-024 (NCT02142738) designs
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The combination is described as more effective when the trial measured more toxicity too
In plain words
Adding ipilimumab lengthens progression-free survival, but grade 3 or 4 side effects rise steeply and a substantial minority stop treatment because of them. Efficacy summaries often quote the first number without the second.
What was measured
That the combination is proven superior to nivolumab monotherapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In CheckMate 067 the combination arm reported treatment-related grade 3-4 adverse events in a majority of patients against roughly a fifth on nivolumab alone, with discontinuation for toxicity far higher. The trial was not statistically powered to compare combination against nivolumab monotherapy, so a claim that the combination is superior to nivolumab alone rests on descriptive comparison.
Source
Larkin et al., NEJM 2015, safety analysis and stated statistical plan
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Second-line lung cancer: the first survival benefit over docetaxel
In plain words
In previously treated advanced lung cancer, nivolumab extended overall survival compared with docetaxel, the standard chemotherapy of the time, with far less severe toxicity.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CheckMate 017 in squamous and CheckMate 057 in non-squamous histology both showed improved overall survival against docetaxel and supported the March 2015 and October 2015 label expansions. These were the results that established PD-1 blockade in lung cancer before the first-line question was settled.
Source
OPDIVO US Prescribing Information, Clinical Studies section
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

Where else this substance is registered

FDA substance identifier (UNII)
31YO63LBSN
RxNorm concept
1597876

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Reviewed first-read answer.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S3, S4.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 5 approved applications cover products containing this substance. The earliest was BLA125554, approved 20141222 to BRISTOL MYERS SQUIBB.

    Drugs@FDA application register · BLA125554 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA125554 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20111219.

    FDA National Drug Code directory · 0003-3120 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

4 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A fully human IgG4 antibody against PD-1 that, combined with ipilimumab, produced a median progression-free survival of 11.5 months in untreated metastatic melanoma against 2.9 months for ipilimumab alone.

Recorded evidence blocks (13)

What did Nivolumab's largest trial (8300 people) and its longest (29 years) measure?


8300 people in Nivolumab's largest registered study, 29 years in its longest registered window, measuring Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose. ClinicalTrials.gov · 2026-09-01

957 phase2, 582 phase1, 156 phase3, 55 na or unstated, 28 early phase1, 13 na, 11 phase4; NCT05732389; 2052-02; no ageing endpoint recorded. Last human test completed 2026, NCT03143270.

Interpretation These counts include studies where Nivolumab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase2
    957
  • phase1
    582
  • phase3
    156
  • na or unstated
    55
  • early phase1
    28
  • na
    13
2 more recorded rows
  • phase4
    11
  • Last recorded human test NCT03143270
    2026-08-03

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Nivolumab shown biomarker?


mouse: mechanism-only, rat: mechanism-only and human: biomarker (1519): the rungs where Nivolumab has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat mechanism-onlyDog Non-human primate Human biomarker
Show the evidence
  • mouse
    mechanism-only
  • rat
    mechanism-only
  • human NCT00441337
    biomarker; Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose; 1519

recorded 2026-09-01 · last checked 2026-09-04

296 of Nivolumab's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (23), futility/efficacy (16), accrual/recruitment (82), funding/business (66), sponsor decision unspecified (18) and other (91): Nivolumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Inadequate accrual rate"; 296 of 1519 registered studies

Show the evidence

Trial

  • NCT01940809
    terminated; "Inadequate accrual rate"
  • NCT02054520
    terminated; "Withdrawal of IND"
  • NCT02323126
    terminated; "Sponsor decision due to low patient recruitment caused by the change in the treatment landscape of NSCLC."
  • NCT02341625
    terminated; "Study terminated for business reasons not related to safety."
  • NCT02357732
    withdrawn; "PI decided not to proceed"
  • NCT02400385
    withdrawn; "With recent advances in immunotherapy scientific question not significant"
14 further recorded trials
  • NCT02408861
    terminated; "Inadequate accrual rate"
  • NCT02419495
    terminated; "Administratively Complete"
  • NCT02423954
    terminated; "Investigator no longer at site to enroll patients or write up data"
  • NCT02446860
    terminated; "The study was unable to recruit the target number of patients (enrolled 15 instead of 19) and did not extend recruitment."
  • NCT02466568
    withdrawn; "Funding unavailable"
  • NCT02469701
    terminated; "Lack of accrual"
  • NCT02472977
    terminated; "Trial terminated because of lack of efficacy in the short term acute phase"
  • NCT02595918
    terminated; "Inadequate accrual rate"
  • NCT02599649
    terminated; "Enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies."
  • NCT02621515
    terminated; "In the Netherlands we wanted to add pilimumab to nivolumab. This resulted in a very long METC procedure which resulted in a to slow inclusion rate."
  • NCT02635061
    terminated; "Lack of efficacy"
  • NCT02648633
    terminated; "The pharmaceutical company (BMS) would no longer provide nivolumab for the study, so the study was terminated early."
  • NCT02681302
    terminated; "Lack of Accrual"
  • NCT02702492
    terminated; "sponsor decision"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Nivolumab used Nivolumab 240 mg every 2 weeks — over how long?


studies of Nivolumab used the recorded amount. ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; also "Nivolumab 240 mg every 2 weeks", "Nivolumab (240 mg)", "Nivolumab - 240 mg"

Show the evidence

human

  • NCT01998126
    Nivolumab 240 mg every 2 weeks
  • NCT02259231
    Nivolumab (240 mg)
  • NCT02648997
    Nivolumab - 240 mg
  • NCT02648997
    Nivolumab - 480 mg
  • NCT02648997
    Nivolumab - 3 mg/kg
  • NCT02648997
    Nivolumab - 1 mg/kg
14 more recorded rows
  • human NCT03081689
    Nivolumab 360 mg
  • human NCT03117309
    Nivolumab 240 mg
  • human NCT03117309
    Nivolumab 3mg/kg
  • human NCT03117309
    Nivolumab 360mg
  • human NCT03132493
    Nivolumab 10 MG/ML
  • human NCT03233152
    Nivolumab (OpdivoTM, 40 mg/4 mL solution)
  • human NCT03233152
    Nivolumab (OpdivoTM, 40 mg/4mL solution)
  • human NCT03277924
    Nivolumab 100 MG/10 ML [Opdivo]
  • human NCT03343665
    Nivolumab 40 mg in 4 ml Injection
  • human NCT03588936
    Nivolumab (.25 mg/kg)
  • human NCT03588936
    Nivolumab (.5 mg/kg)
  • human NCT03634800
    Nivolumab 240mg
  • human NCT03697564
    Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
  • human NCT03844256
    nivolumab 480mg

recorded 2026-09-01 · last checked 2026-09-04

Nivolumab's half-life is 25 days — which schedules were studied?


25 days, the half-life Nivolumab's label states. openfda-label · f570b9c4-6846-4de2-abfa-4d0a4ae4e394 · 2026-08-28

Show the evidence
  • half life
    25 days; The geometric mean elimination half-life (t 1/2 ) is 25 days (77.5%).

recorded 2026-08-28 · last checked 2026-09-04

Which of 2 year overall survival, adverse events and adverse events leading to discontinuation did Nivolumab's trials measure?


2 year overall survival, adverse events and adverse events leading to discontinuation lead 40 outcome terms across Nivolumab's trials. ClinicalTrials.gov · 2026-09-01

best overall response rate, time to relapse, progression free survival, that experienced drug related grade 3 4 aes, that experienced drug related grade 3 4 saes and adverse events follow.

Show the evidence
  • an adverse event
    1
  • serious adverse event
    1
  • deaths
    1
  • best overall response rate
    1
  • time to relapse
    1
  • progression free survival
    1
14 more recorded rows
  • that experienced drug related grade 3 4 aes
    1
  • that experienced drug related grade 3 4 saes
    1
  • adverse events
    1
  • serious adverse events
    1
  • adverse events leading to discontinuation
    1
  • who died
    1
  • laboratory abnormalities in specific liver tests
    1
  • laboratory abnormalities in specific thyroid tests
    1
  • objective response rate
    1
  • overall survival
    1
  • overall survival rate
    1
  • rate of progression free survival
    1
  • cr rate
    1
  • objective response
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Nivolumab's 532 ongoing trials reports first?


532 registered trials of Nivolumab are open; earliest completion 2022-04. ClinicalTrials.gov · 2026-09-01

Overall Response Rate as Measured by the Cheson 2007 Criteria; Maximum tolerated dose (MTD) of each combination (Phase I); latest 2052-02

Show the evidence

Trial

  • NCT01703949
    "Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma"; n 28; "Overall Response Rate as Measured by the Cheson 2007 Criteria"; 2030-06-03
  • NCT01896999
    "Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma"; n 146; "Maximum tolerated dose (MTD) of each combination (Phase I)"; 2026-12-31
  • NCT02099058
    "A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors"; n 237; "Number of Participants with Adverse Events"; 2026-08
  • NCT02194738
    "Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)"; n 8300; "Central and local clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E4512 and A081105"; 2026-09-28
  • NCT02210117
    "Nivolumab With or Without Bevacizumab or Ipilimumab Before Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed by Surgery"; n 104; "Incidence of adverse events, defined any grade 3 or higher adverse event that is possibly, probably, or definitely related to any therapy received on this protocol"; 2026-12-31
  • NCT02224781
    "Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma"; n 267; "2-year Overall Survival (OS)"; 2026-12-19
14 further recorded trials
  • NCT02257528
    "Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer"; n 26; "Objective Tumor Response as Assessed by RECIST 1.1 Criteria"; 2027-03-30
  • NCT02259621
    "Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC"; n 39; "Safety as Measured by Number of Participants With Grade 3 and 4 Lab Abnormalities, as Defined by CTCAE v4.03"; 2027-10
  • NCT02275533
    "Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial"; n 82; "Progression Free Survival (PFS)"; 2026-10-08
  • NCT02293980
    "A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)"; n 110; "Maximum Tolerated Dose (MTD)"; 2026-11-30
  • NCT02314169
    "Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer"; n 143; "Overall Response Rate: Number of Participants With Response (Part A)"; 2027-03-20
  • NCT02339571
    "A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma"; n 600; "Overall survival"; 2033-06-30
  • NCT02374242
    "Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases"; n 76; "Intracranial response rate"; 2028-12
  • NCT02393625
    "Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer"; n 57; "Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion"; 2027-04-09
  • NCT02393794
    "Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)"; n 51; "Phase I: Recommended Phase II Dose of romidepsin in combination with cisplatin"; 2026-07
  • NCT02451982
    "Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas"; n 76; "IL17A expression"; 2026-09-30
  • NCT02453620
    "Entinostat, Nivolumab, and Ipilimumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Locally Advanced or Metastatic HER2-Negative Breast Cancer"; n 57; "Incidence of adverse events of entinostat and nivolumab in combination with ipilimumab"; 2026-09-17
  • NCT02465060
    "Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)"; n 6452; "Objective response rate (ORR)"; 2026-12-31
  • NCT02496208
    "Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors"; n 152; "Recommended phase II dose (Phase I)"; 2026-09-30
  • NCT02530463
    "Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome"; n 99; "Overall Response Rate (ORR) in MDS Participants with Hypomethylating Agent Failure"; 2027-09-30

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Nivolumab could settle lifespan?


NCT03241186 measures Assess Recurrence-free survival time (RFS), reading out 2023-09.

132 open trials; n 36; "Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma"

Show the evidence

Trial

  • NCT03241186
    "Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma"; n 36; "Assess Recurrence-free survival time (RFS)"; 2023-09
  • NCT03712202
    "Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma"; n 155; "18-month Progression-free survival (PFS) for each arm of therapy"; 2024-12-23
  • NCT03452579
    "Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM"; n 90; "Overall Survival at 12 Months (OS-12)"; 2025-06-30
  • NCT05595447
    "Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma"; n 20; "Progression free survival"; 2025-10-18
  • NCT04195139
    "Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM"; n 103; "Overall survival outcomes"; 2025-12-31
  • NCT03036098
    "Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer"; n 1314; "Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study"; 2026-05-15
14 further recorded trials
  • NCT05836571
    "Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma"; n 66; "Progression-free survival (PFS)"; 2026-05-15
  • NCT04803877
    "SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma"; n 48; "Compare the 4-month progression-free survival rate to historical controls"; 2026-06
  • NCT05203913
    "Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer"; n 32; "Disease-free survival"; 2026-06-15
  • NCT03341936
    "Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN"; n 29; "1-Year Disease-Free Survival Percentage"; 2026-07-06
  • NCT03233347
    "Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma"; n 82; "Progression free survival"; 2026-07-08
  • NCT03414684
    "Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer"; n 78; "Progression-free Survival"; 2026-07-30
  • NCT04013854
    "Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab"; n 67; "Recurrence-Free Survival"; 2026-08
  • NCT05568095
    "A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body"; n 1040; "Overall survival"; 2026-08
  • NCT05491616
    "Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study"; n 77; "Disease Free survival 18 months"; 2026-10
  • NCT04561206
    "Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma"; n 31; "Progression-free survival (PFS) at 24 months in patients who achieve complete metabolic response (CMR) after 4 cycles of treatment"; 2026-10-02
  • NCT02275533
    "Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial"; n 82; "Progression Free Survival (PFS)"; 2026-10-08
  • NCT03743662
    "Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma"; n 39; "Overall survival"; 2026-11
  • NCT03595124
    "A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)"; n 15; "Progression Free Survival (PFS)"; 2026-11-13
  • NCT03233152
    "A Phase I/II Clinical Trial on the Per-operative Intratumoral Administration of Myeloid Dendritic Cells Plus Ipilimumab and Nivolumab, Followed by Repeated Intracavitary Plus Intravenous Administration of Nivolumab in Patients With Recurrent Glioblastoma."; n 110; "Progression-free survival (PFS)"; 2026-11-17

Which 180 trials of Nivolumab posted no result?


Posted no result
180 of 180 completed trials
Registrations
NCT01629758, NCT02518958, NCT02534506, NCT01176461, NCT02550249 and NCT02935790, and 174 more
Completion dates
oldest 2014-12; newest 2024-08-31
Show the evidence

Trial

  • NCT01629758
    2014-12
  • NCT02518958
    2016-09-12
  • NCT02534506
    2016-11-11
  • NCT01176461
    2016-12-12
  • NCT02550249
    2017-03
  • NCT02935790
    2017-04-07
14 further recorded trials
  • NCT02497508
    2017-07
  • NCT03165409
    2017-09-30
  • NCT02626065
    2017-12-28
  • NCT01998126
    2018-03-29
  • NCT02309177
    2018-09-12
  • NCT03132493
    2018-09-15
  • NCT03192943
    2018-12-11
  • NCT03433534
    2018-12-21
  • NCT02941744
    2019-01
  • NCT02775292
    2019-04-08
  • NCT02483247
    2019-05
  • NCT02716272
    2019-06-22
  • NCT02999295
    2019-08
  • NCT04123925
    2019-09-02

At the median, Nivolumab's trials enrolled 41 people — anything larger?


Median enrolment
41
Largest enrolment
8300
Registered trials counted
1514

What do 9998 spontaneous reports say about Nivolumab — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Nivolumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9998 reaction mentions were counted: malignant neoplasm progression 2832; colitis 1466; pneumonitis 1250; hypothyroidism 1089. open-targets-adr · CHEMBL2108738 · 2026-06-24

Show the evidence
  • malignant neoplasm progression
    2832
  • colitis
    1466
  • pneumonitis
    1250
  • hypothyroidism
    1089
  • adrenal insufficiency
    694
  • hepatitis
    608
4 more recorded rows
  • hypophysitis
    568
  • hyperthyroidism
    553
  • tubulointerstitial nephritis
    479
  • immune-mediated enterocolitis
    459

recorded 2026-06-24 · last checked 2026-09-04

Was Nivolumab studied with exercise?


exercise is named in Nivolumab's label sentences: "This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to…" openfda-label+europepmc · 2020-02-28

1 recorded statement; exercise

Show the evidence
  • exercise
    This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination…

recorded 2020-02-28 · last checked 2026-09-04

What is recorded about Nivolumab and mTOR?


"Key examples include RAS-targeting peptides such as KRpep-2D, cyclo-CRVLIR, L5UR, RAS-binding peptide (RBP), the mutant KRAS peptide vaccine combined with Nivolumab and Ipilimumab, cyclorasin B4-27, and LUNA18, as well as mTOR-targeting peptides like P1_WT, PDHK1-241aa, TRIM1-269aa, and the micropeptide human small regulatory polypeptide…" — where Nivolumab and mTOR appear together. Europe PMC · pathway abstract search · 2025-11-25

mTOR; PMID 40674852, 38356955, 41374963

Show the evidence

mTOR

  • PMID 40674852
    "Key examples include RAS-targeting peptides such as KRpep-2D, cyclo-CRVLIR, L5UR, RAS-binding peptide (RBP), the mutant KRAS peptide vaccine combined with Nivolumab and Ipilimumab, cyclorasin B4-27, and LUNA18, as well as mTOR-targeting peptides like P1_WT, PDHK1-241aa, TRIM1-269aa, and the micropeptide human small regulatory polypeptide of amino acid response (hSPAR)."
  • PMID 38356955
    "Consequently, temsirolimus, functioning as an mTOR inhibitor, was introduced as an adjunct to the nivolumab/ipilimumab regimen."
  • PMID 41374963
    "This overview provides a concise synthesis of targeted therapies under investigation or already in clinical use, including monoclonal antibodies against epidermal growth factor receptor (EGFR) (e.g., cetuximab) and immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab), as well as inhibitors of programmed cell death protein 1 (PD-1) and its ligand (PD-L1) or agents targeting angiogenic and…"

recorded 2025-11-25 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2108738
CAS number
946414-94-4
RxCUI
1597876
Development code
BMS-936558, BMS-986298, MDX-1106, MDX1106, ONO-4538
Trade name
Nivolumab bms, Nivolumab component of bms-986213, Nivolumab component of opdualag, Opdivo, Opdualag
Also called
anti-pd-1, anti-pd-1 antibodies, anti-pd-1 monoclonal antibodies, anti-pd1, ici, monoclonal antibodies, nivo, nivo40, nivolumab-800cw, pd-1/pd-l1 inhibitors, pembrolizumab, BMS-986213 COMPONENT NIVOLUMAB
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.