This page shows what was measured, who it was measured in, and what that does not settle.
What Pembrolizumab does in the body
Your T cells carry a safety catch called PD-1 that stops them attacking your own tissue.
Many tumours learn to press that catch and switch the attack off. Pembrolizumab is an antibody that caps the catch so the tumour cannot reach it. It does not attack the cancer itself; it takes the brake off the immune cells that were already trying to.
Why people take it. Used for many advanced cancers by helping immune cells attack tumours.
What happened in people
In advanced melanoma, about 47% had no worsening at six months, compared with about 27% on the older treatment.
✓ 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
A tumour test can raise the chance of benefit, but it cannot predict who will respond.
Where it acts
Tumour microenvironment and 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 · DPT0O3T46P · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
A reviewer approved this sentence against this exact record and its sources.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 92 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 people◇Read 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 NCT01866319, Percentage of Participants With Overall Survival (OS) at 12 Months (primary outcome measure): percentage of participants alive, reported with a 95% confidence interval was Pembrolizumab Q2W: 74.1 (68.5 to 78.9); Pembrolizumab Q3W: 68.4 (62.5 to 73.6) against Ipilimumab: 58.2 (51.8 to 64.0) in the comparison group at Month 12.
ClinicalTrials.gov record · NCT01866319 · read 2026-08-28
Progression-free survival and overall survival versus ipilimumab in advanced melanoma
✓ The study showed what it set out to show
Who was studied
KEYNOTE-006 (NCT01866319)
How many people
834
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 for progression-free survival; HR 0.58
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. 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. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ClinicalTrials.gov, KEYNOTE-006 (NCT01866319) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 3 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 people◇Read 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.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.8 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo 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 body◇Read 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 · 9333c79b-d487-4538-a9f0-71b91a02b287 · read 2026-08-28
Start
Pembrolizumab
What a person takes: Intravenous infusion, 30 minutes.
The measurement behind this step
Fixed dosing of 200 mg every 3 weeks or 400 mg every 6 weeks, diluted in saline or dextrose and given through a 0.2-5 micron in-line filter.
Getting in
Intravenous infusion and distribution to tumour tissue
The antibody is dripped into a vein over half an hour and spreads through the blood and into the fluid around the tumour.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Fixed 200 mg every three weeks or 400 mg every six weeks, with a small volume of distribution of roughly 6 L confined largely to plasma and interstitium, and a terminal half-life near 22 days.
It travels into the tumour and the lymph nodes draining it, where the T cells that were switched off are waiting.
╌╌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
Convective transport across leaky tumour vasculature delivers IgG into the interstitium. Target-mediated disposition on PD-1-expressing CD8 T cells in tumour and lymphoid tissue contributes to clearance.
Both arms of the antibody clamp over the safety catch on the T cell so the tumour can no longer press it.
╌╌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 extracellular IgV domain with picomolar affinity, sterically occluding both PD-L1 and PD-L2 engagement. The S228P hinge mutation prevents IgG4 Fab-arm exchange that would otherwise create monovalent hybrids.
Inhibitory signalling stops and the T cell re-arms
With the catch capped, the switched-off T cell recovers its ability to divide and kill.
╌╌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
Without PD-1 ligation, SHP-2 is not recruited to the cytoplasmic ITSM, so CD28 and TCR-proximal signalling through PI3K-AKT and RAS-MAPK is no longer dephosphorylated. Effector transcription, IL-2 production and granzyme B release recover.
Restored T cells attack the tumour. In a minority of patients the response continues for years after the last dose, which chemotherapy almost never does.
╌╌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 formation of memory populations underlies the long plateau on Kaplan-Meier curves. The IgG4 isotype was chosen precisely because it recruits little ADCC or complement, so the antibody does not destroy the T cells it binds.
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 take◇Read 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
Meaningful
Things that change how a life goes, not only a number.
overall survival at 12 months
overall survival
part 2 progression free survival
progression free survival
progression free survival rate at month 6
phase 3 overall survival
6 month progression free survival
progression free survival at 6 months
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 (31)
response rate
who experienced an adverse event
maximum tolerated dose
who experienced dose limiting toxicities
who experienced at least one adverse event
who discontinued study treatment due to an adverse event
experiencing adverse events
discontinuing study drug due to aes
who experienced one or more adverse events
who have a clinical response to treatment
overall response rate
teaes and saes observed during the study of pegilodecakin
part 1 change from baseline in vital signs
clinical response rate
dose limiting toxicities
experiencing adverse events of special interest
objective response rate
serious and non serious adverse events
experiencing dose limiting toxicities
phase 2 objective 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 take◇Read 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.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
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.
How fast the body clears it. 22 days
Read from the label, which states: “The terminal half-life (t 1/2 ) is 22 days (32%).”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
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 unclear◇Read 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 or metastatic cancer across more than fifteen tumour types, and increasingly in the pre-operative and post-operative setting in melanoma, lung and breast cancer.
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
NCT01866319 recorded its participants as: Minimum age 18 years; all sexes eligible, as recorded in the registry eligibility module.
ClinicalTrials.gov record · NCT01866319 · read 2026-08-28
It included: Histologically-confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy (excluding uveal or ocular melanoma); At least one measurable lesion; No prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (first line) or one prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (second line); Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Archived tissue sample or new biopsy sample.
ClinicalTrials.gov record · NCT01866319 · read 2026-08-28
It excluded: Prior treatment with ipilimumab or other anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) agent or any anti-programmed cell death (PD-1 or PD-L2) agent; History of a malignancy (other than the disease under treatment in the study) within 5 years prior to first study drug administration, excluding adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other in situ cancers.; Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases are eligible; Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents; Active infection requiring systemic therapy; Known history of Human Immunodeficiency Virus (HIV).
ClinicalTrials.gov record · NCT01866319 · read 2026-08-28
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of KEYTRUDA in pediatric patients have not been established in the other approved indications [see Indications and Usage (1) ] .”
US prescribing information · 9333c79b-d487-4538-a9f0-71b91a02b287 · read 2026-08-30
On older people, the label states: “Clinical studies of KEYTRUDA in cHL did not include sufficient numbers of patients aged 65 years and over to determine whether effectiveness differs from that in younger patients.”
US prescribing information · 9333c79b-d487-4538-a9f0-71b91a02b287 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman.”
US prescribing information · 9333c79b-d487-4538-a9f0-71b91a02b287 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of pembrolizumab in either animal or human milk or its effects on the breastfed child or on milk production.”
US prescribing information · 9333c79b-d487-4538-a9f0-71b91a02b287 · read 2026-08-30
Where the result stopped carrying
KEYNOTE-183 and KEYNOTE-185 in multiple myeloma were halted by the FDA in July 2017 for excess mortality
Single-agent activity in microsatellite-stable colorectal cancer and in pancreatic cancer has been minimal despite the tissue-agnostic approval
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 take◇Read 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 take◇Read 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
2-5 micron in-line filter.
✎ 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 take◇Read 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 adverse reactions can affect any organ and may appear after treatment stops. Pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and severe cutaneous reactions all carry label warnings. Fatal immune-mediated events have occurred.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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.
Pembrolizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10042 reaction mentions were counted. One report can name several reactions.
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 unclear◇Read 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
2-5 micron in-line filter.
✎ 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
10 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.
FDA National Drug Code directory · 43624-030 · read 2026-08-29
They are sold as injection, solution, liquid and solution, taken intravenous and subcutaneous.
FDA National Drug Code directory · 43624-030 · 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 · 43624-030 · read 2026-08-29
2 published labels name it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 097d166f-b73b-41d3-9b37-7653cd2a0c41 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 097d166f-b73b-41d3-9b37-7653cd2a0c41 · read 2026-08-29
Keytruda is injection: solution in a single-dose vial for intravenous use at 100 mg/4 mL (25 mg/mL) solution in a single-dose vial, recorded as prescription product; fda label in effect 2026-07-10 in the United States.
US prescribing information · 9333c79b-d487-4538-a9f0-71b91a02b287 · 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 take◇Read 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 Pembrolizumab 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 unclear◇Read 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 a PD-L1 tumour proportion score predicts individual response rather than enriching a population
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 checkpoint blockade helps in any cancer where the immune system is involved; myeloma is the counterexample where it caused harm
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 long-term survivors are cured; the plateau on the survival curve is descriptive and the durability threshold has never been prospectively defined
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 unclear◇Read 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 Pembrolizumab 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 people◇Read 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.
KEYNOTE-006: pembrolizumab beat ipilimumab in advanced melanoma
In plain words
In 834 people with advanced melanoma, roughly 47% were free of progression at six months on pembrolizumab against 26.5% on the previous standard, ipilimumab, with less severe toxicity.
What was measured
6-month progression-free survival 47.3% versus 26.5%; HR for progression 0.58
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised phase 3, three arms. Estimated 6-month progression-free survival was 47.3% for pembrolizumab every 2 weeks, 46.4% every 3 weeks and 26.5% for ipilimumab (hazard ratio 0.58). Overall survival also favoured pembrolizumab, and grade 3-5 treatment-related events were less frequent than with ipilimumab.
Written into the record, not signed off as a reviewed claim
KEYNOTE-024: first-line monotherapy beat chemotherapy in PD-L1-high lung cancer
In plain words
In 305 people with previously untreated advanced lung cancer whose tumours carried PD-L1 on at least half of cells, pembrolizumab alone delayed progression from a median of 6.0 to 10.3 months and extended survival.
What was measured
Median progression-free survival 10.3 versus 6.0 months, HR 0.50
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Open-label phase 3 with blinded independent central review of the primary endpoint. Median progression-free survival 10.3 versus 6.0 months (hazard ratio 0.50, 95% CI 0.37-0.68, p < 0.001), with longer overall survival and fewer treatment-related adverse events than platinum doublet chemotherapy. Crossover from chemotherapy was permitted, which biases the survival comparison conservatively.
Written into the record, not signed off as a reviewed claim
KEYNOTE-183: the FDA halted the myeloma trial because patients on pembrolizumab died sooner
In plain words
Adding pembrolizumab to standard myeloma treatment made outcomes worse, not better. Regulators stopped the trial in July 2017 after an unplanned interim analysis.
What was measured
Median progression-free survival 5.6 versus 8.4 months, HR 1.53 against the experimental arm
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Randomised open-label phase 3 in relapsed or refractory multiple myeloma, 249 patients randomised to pomalidomide and dexamethasone with or without pembrolizumab. Median progression-free survival was 5.6 months with pembrolizumab versus 8.4 months without (hazard ratio 1.53, 95% CI 1.05-2.22). Six-month overall survival was 82% versus 90%. The FDA halted the study on 3 July 2017 on the grounds that risk outweighed benefit. The companion trial KEYNOTE-185 in newly diagnosed myeloma was halted at the same time.
Written into the record, not signed off as a reviewed claim
PD-L1 expression is treated as a test that says who will respond
In plain words
A high PD-L1 score raises the odds of benefit but does not predict it for an individual, and low-scoring tumours still respond. The biomarker enriches a trial population; it does not sort patients into responders and non-responders.
What was measured
That a PD-L1 tumour proportion score identifies which individual patients will respond
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
KEYNOTE-024 restricted enrolment to tumour proportion score of 50% or more, which is an enrichment design and cannot establish that the assay predicts individual benefit. PD-L1 immunohistochemistry is subject to assay-to-assay variation, intratumoural heterogeneity and temporal drift between archival and fresh biopsy. Tissue-agnostic approval on microsatellite instability rests on a different and better-defined biomarker.
Source
Enrichment design of KEYNOTE-024 and the assay-comparison literature
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
From tumour type to tumour genotype: the first tissue-agnostic approval
In plain words
In 2017 the FDA approved pembrolizumab for any solid tumour with a specific DNA repair defect, regardless of which organ the cancer started in. That broke a century-old convention that cancer drugs are approved by organ of origin.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Accelerated approval for microsatellite-instability-high or mismatch-repair-deficient unresectable or metastatic solid tumours was granted in May 2017 on pooled objective response data across tumour types. The mechanistic rationale is that mismatch repair deficiency generates a high neoantigen burden that checkpoint blockade can exploit. The shift reframed the biomarker, not the antibody.
Source
FDA accelerated approval of pembrolizumab for MSI-H/dMMR solid tumours, May 2017
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
Immune-related toxicity is a distinct and sometimes permanent harm
In plain words
Taking the brake off the immune system lets it attack healthy organs too. Thyroid failure is usually permanent, and pneumonitis, colitis, hepatitis and hypophysitis can be life-threatening.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label carries warnings for immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies including hypophysitis, thyroid disorders and type 1 diabetes, nephritis, and severe skin reactions, plus infusion-related reactions and complications of allogeneic haematopoietic stem cell transplantation. Endocrine damage frequently requires lifelong hormone replacement even after the antibody is stopped.
Source
KEYTRUDA US Prescribing Information, Warnings and Precautions
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)
DPT0O3T46P
RxNorm concept
1547545
Checks this page had to pass
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Identity resolved
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no quarantine open
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Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
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Safety mode resolved
Suppression classes recorded: S1, S3, S4.
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Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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
2 approved applications cover products containing this substance. The earliest was BLA125514, approved 20140904 to MERCK SHARP DOHME.
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
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Other ways to the same goal — found nothing in the sources checked.
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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 humanised IgG4 antibody that unplugs the PD-1 off-switch on T cells, raising 12-month overall survival in advanced melanoma above ipilimumab and doubling median progression-free survival in PD-L1-high lung cancer from 6.0 to 10.3 months.
Recorded evidence blocks (13)
Q2
What did Pembrolizumab's largest trial (12000 people) and its longest (25 years) measure?
12000 people in Pembrolizumab's largest registered study, 25 years in its longest registered window, measuring Pharmacokinetic (PK): Serum Concentration of Pegilodecakin. ClinicalTrials.gov · 2026-09-01
1415 phase2, 864 phase1, 317 phase3, 47 na or unstated, 36 early phase1, 17 na, 10 phase4; NCT03486873; 2043-08-04; no ageing endpoint recorded. Last human test completed 2026, NCT03131908.
Interpretation These counts include studies where Pembrolizumab 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
1415
phase1
864
phase3
317
na or unstated
47
early phase1
36
na
17
2 more recorded rows
phase4
10
Last recorded human testNCT03131908
2026-08-20
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Pembrolizumab shown biomarker?
"Business Reasons"; 446 of 2300 registered studies
Show the evidence
Trial
NCT02036502
terminated; "Business Reasons"
NCT02054520
terminated; "Withdrawal of IND"
NCT02212730
terminated; "Terminated early due to low enrollment"
NCT02268825
terminated; "Merck requested to change MK-3475 dosing schedule; PI decided to close instead"
NCT02289222
terminated; "Due to the inclusion of an IMid in combination with pembrolizumab, Study Sponsor terminated the study."
NCT02318901
terminated; "PI no longer at sight. Results not collected"
14 further recorded trials
NCT02331251
terminated; "PI not longer at site."
NCT02359851
terminated; "Slow accrual"
NCT02376699
terminated; "Study closed due to portfolio prioritization"
NCT02382406
terminated; "The study was completed. It was fully accrued."
NCT02395627
terminated; "Insufficient efficacy in an unselected patient population"
NCT02419495
terminated; "Administratively Complete"
NCT02452424
terminated; "Terminated early for insufficient evidence of clinical efficacy"
NCT02499952
terminated; "Lack of Efficacy"
NCT02501473
terminated; "Business reasons"
NCT02511184
terminated; "Decision based on the low enrollment mainly due to high efficacy drugs available in 1st line ALK-positive NSCLC (eg alectinib), not due to any safety concerns"
NCT02521870
terminated; "A strategic restructuring including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101."
NCT02530502
terminated; "The protocol was amendment to be stopped after phase I (phase 2 removed from protocol)"
NCT02535247
terminated; "Merck no longer providing drug for study"
NCT02553499
terminated; "Enrollment prematurely discontinued due to program prioritization \& not due to any safety concerns."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Pembrolizumab used Pembrolizumab 2 mg/kg — over how long?
20 recorded entries; human; IV; also "Pembrolizumab 2 mg/kg", "Pembrolizumab 10 mg/kg", "Pembrolizumab 200 mg"
Show the evidence
human
NCT01840579
Pembrolizumab 2 mg/kg
NCT01840579
Pembrolizumab 10 mg/kg
NCT01840579
Pembrolizumab 200 mg
NCT02862457
pembrolizumab 200 mg
NCT02938624
IV; Pembrolizumab 200 mg IV single dose
NCT02938624
IV; Pembrolizumab 200 mg IV twice interval 21 days
14 more recorded rows
humanNCT02938624
IV; Pembrolizumab 200 mg IV Twice interval 21d,surgery after 10d
humanNCT02938624
Pembrolizumab 100 mg I.V single dose
humanNCT03006926
pembrolizumab (200 mg)
humanNCT03139851
Pembrolizumab 100 MG in 4 ML Injection
humanNCT03274661
Pembrolizumab 200 mg Q3W
humanNCT03637803
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
humanNCT04135352
200 mg of pembrolizumab
humanNCT04198766
pembrolizumab 400 mg
humanNCT04230954
IV; Pembrolizumab 200 mg IV every 3 weeks
humanNCT04260529
Pembrolizumab 25 MG/ML [KEYTRUDA®]
humanNCT04305795
200 mg Pembrolizumab
humanNCT04602377
Pembrolizumab 25 MG/ML [Keytruda]
humanNCT04624204
Pembrolizumab 400 mg
humanNCT04892472
Pembrolizumab (MK-3475) 200 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Pembrolizumab's half-life is 22 days — which schedules were studied?
22 days, the half-life Pembrolizumab's label states. openfda-label · 9333c79b-d487-4538-a9f0-71b91a02b287 · 2026-08-28
Show the evidence
half life
22 days; The terminal half-life (t 1/2 ) is 22 days (32%).
recorded 2026-08-28 · last checked 2026-09-04
Q7
Which of 6 month progression free survival, adverse events and clinical response rate did Pembrolizumab's trials measure?
6 month progression free survival, adverse events and clinical response rate lead 40 outcome terms across Pembrolizumab's trials. ClinicalTrials.gov · 2026-09-01
who experienced dose limiting toxicities, who experienced at least one adverse event, who discontinued study treatment due to an adverse event, experiencing adverse events, overall survival at 12 months and overall survival follow.
Show the evidence
response rate
1
who experienced an adverse event
1
maximum tolerated dose
1
who experienced dose limiting toxicities
1
who experienced at least one adverse event
1
who discontinued study treatment due to an adverse event
1
14 more recorded rows
experiencing adverse events
1
overall survival at 12 months
1
overall survival
1
discontinuing study drug due to aes
1
who experienced one or more adverse events
1
who have a clinical response to treatment
1
overall response rate
1
teaes and saes observed during the study of pegilodecakin
1
pharmacokinetic serum concentration of pegilodecakin
1
part 1 change from baseline in vital signs
1
part 2 progression free survival
1
clinical response rate
1
dose limiting toxicities
1
experiencing adverse events of special interest
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Pembrolizumab's 1014 ongoing trials reports first?
Response rate; Dose limiting toxicities at 6 weeks post T cell infusion; latest 2043-08-04
Show the evidence
Trial
NCT01174121
"Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer"; n 332; "Response rate"; 2029-12-27
NCT01822652
"3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN"; n 11; "Dose limiting toxicities at 6 weeks post T cell infusion"; 2030-10
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
NCT02287428
"Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM"; n 56; "Cohorts 1, 1a, 1b, & 1c: Number of participants with Adverse Events as a measure of safety and tolerability"; 2028-02
NCT02298959
"Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer"; n 59; "Recommended combination dose of ziv-aflibercept and pembrolizumab"; 2027-01-20
NCT02312557
"Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide"; n 58; "PSA Response, Defined by a PSA Decrease of at Least 50% Confirmed by a Second Measurement at Least 3 Weeks Later"; 2026-10-31
14 further recorded trials
NCT02332668
"A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)"; n 370; "Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors and Other Lymphoma Version 1.1 (RECIST 1.1) per Site Assessment (Each Disease Indication Evaluated Separately)"; 2028-02-02
NCT02337686
"Pembrolizumab in Treating Patients With Recurrent Glioblastoma"; n 18; "Number of Participants With Progression Free Survival at 6 Months"; 2026-12-31
NCT02359565
"Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma"; n 71; "Incidence of adverse events"; 2027-01-16
NCT02362594
"Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)"; n 1019; "Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants"; 2026-11-01
NCT02411656
"Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy"; n 71; "To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC"; 2028-12-31
NCT02414269
"Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin"; n 113; "Composite measure of severity and number of adverse events (AEs); changes in (clinical laboratory test findings (hematologic and chemistry); and physical examination. (Phase I)"; 2027-04-30
NCT02422381
"MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)"; n 16; "Dose Limiting Toxicities"; 2026-12
NCT02432963
"Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy"; n 11; "Tolerability of combined modified vaccinia virus Ankara vaccine expressing p53 and pembrolizumab, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.3"; 2026-10-02
NCT02446457
"Rituximab and Pembrolizumab With or Without Lenalidomide in Treating Patients With Relapsed Follicular Lymphoma and Diffuse Large B-Cell Lymphoma"; n 53; "Overall Response Rate (Complete + Partial Responses)"; 2026-04-30
NCT02506153
"Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery"; n 1301; "Overall Survival (OS)"; 2027-01-23
NCT02521844
"A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours"; n 89; "Maximum Tolerated Dose (MTD) of ETC-1922159 when administered with pembrolizumab (Part B Dose Escalation)"; 2024-10-31
NCT02560636
"Pembrolizumab in Muscle Invasive/Metastatic Bladder Cancer"; n 34; "Establishing the maximum tolerated dose (MTD)"; 2028-07-30
NCT02600949
"Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer"; n 300; "Proportion of enrolled patients for whom a personalized vaccine is developed and ready to administer (cohorts A and B)"; 2027-05-31
NCT02603887
"Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma"; n 20; "Overall Response Rate (ORR)"; 2027-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Pembrolizumab could settle lifespan?
NCT05595447 measures Progression free survival, reading out 2025-10-18.
270 open trials; n 20; "Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma"
Show the evidence
Trial
NCT05595447
"Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma"; n 20; "Progression free survival"; 2025-10-18
NCT02621151
"Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder"; n 60; "Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival"; 2025-12
NCT04713514
"OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC"; n 180; "Progression free survival (PFS)"; 2025-12
NCT04547504
"PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %"; n 349; "Progression-free survival (PFS) according to RECIST 1.1 assessed by blinded inependant centra review (BICR)"; 2025-12-22
NCT02769520
"Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck"; n 27; "Disease-Free Survival"; 2026-04
NCT04032418
"Pembrolizumab Every 12 Weeks Versus Every 3 Weeks in Treating Patients With Non-small Cell Lung Cancer"; n 9; "1-year progression-free survival (PFS)"; 2026-06-14
14 further recorded trials
NCT04753879
"Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer."; n 38; "Progression-free Survival (PFS) after 6 months according to RECIST 1.1 criteria."; 2026-07-01
NCT04634877
"Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)"; n 990; "Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence"; 2026-09-15
NCT03914612
"Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer"; n 813; "Progression-free Survival (PFS)"; 2026-09-26
NCT05689671
"Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma"; n 136; "Overall Survival (OS)"; 2026-10
NCT04548752
"Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations"; n 88; "Progression-free survival (PFS)"; 2026-10-01
NCT03425643
"Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)"; n 797; "Event Free Survival (EFS)"; 2026-10-15
NCT03698019
"A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma"; n 313; "Two-Year Event-Free Survival Rate"; 2026-10-30
NCT03244384
"Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer"; n 739; "Overall survival"; 2026-10-31
NCT05852691
"A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer"; n 83; "Progression-Free Survival (PFS)"; 2026-10-31
NCT06448312
"A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer"; n 406; "Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)"; 2026-11
NCT02362594
"Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)"; n 1019; "Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants"; 2026-11-01
NCT04887805
"Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer"; n 28; "Progression free survival"; 2026-11-05
NCT03765918
"Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)"; n 714; "Event-free Survival (EFS)"; 2026-11-17
NCT03899857
"Pembrolizumab for Newly Diagnosed Glioblastoma"; n 56; "Overall survival at 12 months"; 2026-12
Q10
Which 136 trials of Pembrolizumab posted no result?
Posted no result
136 of 136 completed trials
Registrations
NCT02303366, NCT02722954, NCT02574533, NCT02823405, NCT02492568 and NCT02607631, and 130 more
Completion dates
oldest 2017-04; newest 2024-08-21
Show the evidence
Trial
NCT02303366
2017-04
NCT02722954
2017-05-19
NCT02574533
2017-09
NCT02823405
2018-03-15
NCT02492568
2018-06
NCT02607631
2018-08
14 further recorded trials
NCT02620423
2018-08
NCT02950220
2019-01-03
NCT02826564
2019-02-18
NCT02014636
2019-02-27
NCT02665650
2019-03
NCT02483247
2019-05
NCT02843204
2019-07-01
NCT03139851
2019-09-18
NCT02909348
2019-10
NCT02565992
2019-11-04
NCT02676869
2019-12
NCT02733250
2019-12-13
NCT03212651
2019-12-13
NCT02840994
2020-01
Q11
At the median, Pembrolizumab's trials enrolled 46 people — anything larger?
Median enrolment
46
Largest enrolment
12000
Registered trials counted
2296
Q12
What do 10042 spontaneous reports say about Pembrolizumab — 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.
Pembrolizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10042 reaction mentions were counted: malignant neoplasm progression 2830; colitis 1461; pneumonitis 1318; hypothyroidism 1081. open-targets-adr · CHEMBL3137343 · 2026-06-24
Show the evidence
malignant neoplasm progression
2830
colitis
1461
pneumonitis
1318
hypothyroidism
1081
adrenal insufficiency
698
hepatitis
608
4 more recorded rows
hypophysitis
561
hyperthyroidism
547
tubulointerstitial nephritis
479
immune-mediated enterocolitis
459
recorded 2026-06-24 · last checked 2026-09-04
Q13
Was Pembrolizumab studied with exercise?
exercise is named in Pembrolizumab's label sentences: "The ExACT-ICI (Exercise in Regional Breast Cancer with adjuvant and neoadjuvant Anthracycline-based ChemoTherapy with Immune Checkpoint-Inhibition, NCT06672120) trial is a prospective single-center study randomizing regional TNBC patients (stage I-III, ages 18-65) receiving anthracycline…" openfda-label+europepmc · 2026-06-05
1 recorded statement; exercise
Show the evidence
exercise
The ExACT-ICI (Exercise in Regional Breast Cancer with adjuvant and neoadjuvant Anthracycline-based ChemoTherapy with Immune Checkpoint-Inhibition, NCT06672120) trial is a prospective single-center study randomizing regional TNBC patients (stage I-III, ages 18-65) receiving anthracycline chemotherapy plus pembrolizumab into exercise training (ET) or usual care groups.
recorded 2026-06-05 · last checked 2026-09-04
Q14
What is recorded about Pembrolizumab and mTOR?
"This classification (refined in ProMisE and TransPORTEC) enables precise treatment: immunotherapy (pembrolizumab, dostarlimab) works excellently in dMMR/MSI-H tumors, PI3K/AKT/mTOR inhibitors and trastuzumab deruxtecan in selected molecular subtypes, and hormone therapy in ER-positive tumors. ctDNA monitoring supports therapeutic…" — where Pembrolizumab and mTOR appear together. Europe PMC · pathway abstract search · 2026-06-27
mTOR; PMID 41681828, 42449635, 39866918
Show the evidence
mTOR
PMID 41681828
"This classification (refined in ProMisE and TransPORTEC) enables precise treatment: immunotherapy (pembrolizumab, dostarlimab) works excellently in dMMR/MSI-H tumors, PI3K/AKT/mTOR inhibitors and trastuzumab deruxtecan in selected molecular subtypes, and hormone therapy in ER-positive tumors. ctDNA monitoring supports therapeutic decisions."
PMID 42449635
"We conducted several exploratory single-arm subgroup analyses and multiple individual patient data (IPD) meta-analyses across several clinically relevant subgroups, including patients treated with progestins, lenvatinib plus pembrolizumab, PI3K/AKT/mTOR inhibitor monotherapy, and PI3K/AKT/mTOR inhibitors in combination with aromatase inhibitors."
PMID 39866918
"The mechanistic target of rapamycin (mTOR) inhibitor everolimus could not be obtained due to lack of insurance coverage, so the patient was treated with single-agent pembrolizumab."
recorded 2026-06-27 · last checked 2026-09-04
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