This page shows what was measured, who it was measured in, and what that does not settle.
What Cemiplimab does in the body
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
From the FDA-approved label: Binding of the PD-1 ligands PD-L1 and PD-L2 to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 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. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
Why people take it. LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
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 · 6QVL057INT · read 2026-08-29
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 195 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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.
Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.
✗ The study did not show it
Who was studied
NCT01042379
How many people
5000
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Relapse free survival (RSF)
✗ The study did not show it
Who was studied
NCT05608291
How many people
1564
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Progression-free survival (PFS)
✗ The study did not show it
Who was studied
NCT05352672
How many people
1546
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy
✗ The study did not show it
Who was studied
NCT03564340
How many people
890
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Part 1: Overall Survival (OS)
✗ The study did not show it
Who was studied
NCT03409614
How many people
789
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Overall Survival (OS)
✗ The study did not show it
Who was studied
NCT03088540
How many people
712
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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.6 registered measures of this kind. 4 written-up studies 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 healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
■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 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.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
overall survival
part 1 overall survival
deaths for ubamatamab monotherapy
progression free survival
progression free survival at 1 year
incidence of deaths
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 (34)
incidence of treatment emergent adverse events
dose limiting toxicities
rate of dose limiting toxicities
rate of adverse events
rate of serious adverse events
laboratory abnormalities
incidence of adverse events of grade 3 or higher
overall response rate
adverse events
dose limiting toxicity for ubamatamab monotherapy
serious adverse events for ubamatamab monotherapy
laboratory abnormalities for ubamatamab monotherapy
rate of treatment emergent adverse events
treatment emergent adverse events
objective response rate
disease control rate
duration of response
time to response
time to treatment failure
incidence and severity of injection site reactions
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 elimination half-life is 22 days (42%).”
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.
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
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.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of LIBTAYO have not been established in pediatric patients.”
US prescribing information · 4347ae1f-d397-4f18-8b70-03897e1c054a · read 2026-08-30
On older people, the label states: “LIBTAYO as a Single Agent Of the 1281 patients with advanced cancers who received LIBTAYO as a single agent in clinical studies, 26% were 65 years up to 75 years and 22% were 75 years or older.”
US prescribing information · 4347ae1f-d397-4f18-8b70-03897e1c054a · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .”
US prescribing information · 4347ae1f-d397-4f18-8b70-03897e1c054a · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of cemiplimab-rwlc in human milk, or its effects on the breastfed child or on milk production.”
US prescribing information · 4347ae1f-d397-4f18-8b70-03897e1c054a · read 2026-08-30
Where the result stopped carrying
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
Still being tested
❝ 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
✎ 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
Sold as injection, given by the intravenous route.
✎ 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∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
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.
Cemiplimab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 152 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
pyrexia — 27 reaction mentions
acute kidney injury — 22 reaction mentions
infusion related reaction — 16 reaction mentions
pneumonitis — 16 reaction mentions
hepatitis — 15 reaction mentions
hepatocellular injury — 13 reaction mentions
interstitial lung disease — 12 reaction mentions
adrenal insufficiency — 11 reaction mentions
cholestasis — 10 reaction mentions
colitis — 10 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 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
✎ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 61755-908 · read 2026-08-29
They are sold as injection and solution, taken intravenous.
FDA National Drug Code directory · 61755-908 · read 2026-08-29
1 published label names 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 · 4347ae1f-d397-4f18-8b70-03897e1c054a · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 4347ae1f-d397-4f18-8b70-03897e1c054a · read 2026-08-29
LIBTAYO is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 350 mg/7 mL (50 mg/mL), clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles in a single-dose vial., recorded as fda label in effect 2025-10-29 in the United States.
US prescribing information · 4347ae1f-d397-4f18-8b70-03897e1c054a · read 2026-08-30
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 Cemiplimab 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
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 Cemiplimab 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.
Where else this substance is registered
FDA substance identifier (UNII)
6QVL057INT
CAS registry number
1801342-60-8
WHO international nonproprietary name list entry
10691
RxNorm concept
2058826
EMA substance identifier
100000175258
DrugBank
DB14707
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: Quoted from a stored source.
✗ 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 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
The earliest marketing start date recorded for a listed product is 20180928.
FDA National Drug Code directory · 61755-908 · read 2026-08-29
What is missing or unclear◇Read 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
6 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.
The path through the body — 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.
Claims that go past the evidence — 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.
Recorded evidence blocks (12)
Q2
What did Cemiplimab's largest trial (5000 people) and its longest (22 years) measure?
5000 people in Cemiplimab's largest registered study, 22 years in its longest registered window, measuring Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each… ClinicalTrials.gov · 2026-09-01
141 phase2, 71 phase1, 17 phase3, 9 na or unstated, 1 early phase1, 1 na; NCT01042379; 2031-12; no ageing endpoint recorded. Last human test completed 2026, NCT02651662.
Interpretation These counts include studies where Cemiplimab 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.
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phase2
141
phase1
71
phase3
17
na or unstated
9
early phase1
1
na
1
1 more recorded row
Last recorded human testNCT02651662
2026-04-29
recorded 2026-09-01 · last checked 2026-09-04
Q3
Cemiplimab was tested only in human — what did it show?
Interpretation Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard… — the recorded outcome words.
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humanNCT01042379
biomarker; Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.; 203
3 recorded entries; human; also "350 mg Cemiplimab", "Cemiplimab 350 MG Intravenous Solution", "Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles"
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human
NCT04305795
350 mg Cemiplimab
NCT07223541
Cemiplimab 350 MG Intravenous Solution
NCT07387198
Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles
recorded 2026-09-01 · last checked 2026-09-04
Q6
Cemiplimab's half-life is 22 days — which schedules were studied?
22 days, the half-life Cemiplimab's label states. openfda-label · 4347ae1f-d397-4f18-8b70-03897e1c054a · 2026-08-30
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half life
22 days; The elimination half-life is 22 days (42%).
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of adverse events, completely adhering to 3 cycles of short term fasting and deaths for ubamatamab monotherapy did Cemiplimab's trials measure?
adverse events, completely adhering to 3 cycles of short term fasting and deaths for ubamatamab monotherapy lead 40 outcome terms across Cemiplimab's trials. ClinicalTrials.gov · 2026-09-01
rate of adverse events, rate of serious adverse events, laboratory abnormalities, incidence of adverse events of grade 3 or higher, overall survival and overall response rate follow.
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incidence of treatment emergent adverse events
1
dose limiting toxicities
1
rate of dose limiting toxicities
1
rate of adverse events
1
rate of serious adverse events
1
laboratory abnormalities
1
14 more recorded rows
incidence of adverse events of grade 3 or higher
1
overall survival
1
overall response rate
1
part 1 overall survival
1
adverse events
1
dose limiting toxicity for ubamatamab monotherapy
1
serious adverse events for ubamatamab monotherapy
1
deaths for ubamatamab monotherapy
1
laboratory abnormalities for ubamatamab monotherapy
1
rate of treatment emergent adverse events
1
treatment emergent adverse events
1
objective response rate
1
disease control rate
1
duration of response
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Cemiplimab's 143 ongoing trials reports first?
Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant…; Incidence of adverse events of grade 3 or higher; latest 2035-11-20
Show the evidence
Trial
NCT01042379
"I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer"; n 5000; "Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry."; 2031-12
NCT03017820
"A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma"; n 99; "Incidence of adverse events of grade 3 or higher"; 2032-04-01
NCT03233139
"Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies"; n 146; "Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab as monotherapy"; 2027-09-30
NCT03491683
"INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)"; n 52; "Percentage of Participants with Adverse Events (AEs)"; 2026-12-31
NCT03564340
"Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers"; n 890; "Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy"; 2027-05-10
NCT03565783
"Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery"; n 44; "Overall response rate"; 2027-12-31
14 further recorded trials
NCT03916627
"Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients"; n 65; "Major pathologic response (MPR) at time of surgery for the NSCLC cohorts"; 2030-05-14
NCT03951831
"REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer"; n 26; "Percentage of Subjects Achieving Undetectable PSA at 6 months after Combination Treatment"; 2028-04
NCT03969004
"Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma"; n 415; "DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause."; 2028-01-07
NCT03972657
"A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors"; n 345; "Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)"; 2027-11-15
NCT04050436
"Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer"; n 231; "Objective Response Rate (ORR) according to blinded independent review"; 2025-09
NCT04243616
"Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer"; n 36; "The Proportion of Breast Cancer Patients With Pathological Complete Response (pCR)."; 2030-08-12
NCT04253964
"Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy"; n 105; "Proportion of Participants with Progression-Free Survival"; 2027-09-01
NCT04291105
"Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients"; n 87; "Objective response rate (ORR) per imaging assessment"; 2026-12
NCT04305795
"An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors"; n 23; "Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy"; 2027-06
NCT04315701
"A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer"; n 35; "Confirmed pathologic partial response"; 2027-12-31
NCT04387084
"Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy"; n 10; "Percentage of patients completely adhering to 3 cycles of short term fasting (STF) (9 days of fasting)"; 2027-08-12
NCT04428671
"Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer"; n 20; "Pathologic response rate"; 2031-10-01
NCT04543071
"Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma"; n 10; "Overall Response Rate (Complete Response (CR) + Partial Response (PR))"; 2028-08
NCT04590326
"A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab"; n 612; "Incidence of Dose Limiting Toxicities (DLT)"; 2027-11-30
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Cemiplimab could settle lifespan?
NCT05574101 measures Event Free Survival, reading out 2026-10-06.
25 open trials; n 34; "A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer"
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Trial
NCT05574101
"A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer"; n 34; "Event Free Survival"; 2026-10-06
NCT05694871
"Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma"; n 77; "Progression-free survival (PFS)"; 2027-05-31
NCT04253964
"Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy"; n 105; "Proportion of Participants with Progression-Free Survival"; 2027-09-01
NCT04988074
"Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca"; n 32; "2-year progression free survival rate"; 2027-12
NCT06908304
"A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC"; n 300; "Overall Survival"; 2027-12-31
NCT05363319
"An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe"; n 500; "Overall survival (OS)"; 2028-10-30
14 further recorded trials
NCT07101822
"A PHASE II, RANDOMIZED STUDY TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT PENILE CANCER"; n 42; "Progression free survival"; 2028-12
NCT07101848
"A PHASE II, RANDOMIZED TRIAL TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT VULVAR CANCER"; n 42; "Progression free survival"; 2028-12
NCT06616584
"Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)"; n 378; "Overall survival (OS)"; 2028-12-31
NCT06931717
"A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy"; n 390; "Disease-free survival (DFS)"; 2029-03
NCT06900595
"Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer"; n 48; "Progression free survival (PFS)"; 2029-06-02
NCT07179315
"A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment"; n 68; "Assess improved recurrence free survival in patients"; 2029-11-30
NCT06790602
"Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma"; n 43; "Overall survival"; 2029-12
NCT06219317
"Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC"; n 136; "Progression-free survival (PFS)"; 2030-01
NCT05608291
"A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery"; n 1564; "Relapse free survival (RSF)"; 2030-04-03
NCT06585410
"Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma"; n 369; "Event-Free Survival (EFS) as assessed by the investigator"; 2030-05-03
NCT07020065
"Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50%"; n 156; "Progression-free survival (PFS)"; 2030-09
NCT07281417
"Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma"; n 108; "Event free survival (EFS)"; 2030-12-16
NCT07223541
"Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma"; n 72; "Proportion of patients with progression-free survival of oligo-metastatic clear cell renal cell carcinoma (ccRCC) patients following stereotactic body radiation therapy (SBRT) and up to one-year of treatment with cemiplimab or cemiplimab…"; 2031-08
NCT05352672
"Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma"; n 1546; "Progression-free survival (PFS)"; 2031-09-16
Q10
Which 8 trials of Cemiplimab posted no result?
Posted no result
8 of 8 completed trials
Registrations
NCT02383212, NCT03198130, NCT03002376, NCT02423863, NCT04898751 and NCT05302297, and 2 more
Completion dates
oldest 2019-11-18; newest 2024-04-02
Show the evidence
Trial
NCT02383212
2019-11-18
NCT03198130
2020-02-21
NCT03002376
2020-03-19
NCT02423863
2020-08-31
NCT04898751
2020-08-31
NCT05302297
2022-09-30
2 further recorded trials
NCT04826393
2024-01-01
NCT03005782
2024-04-02
Q11
At the median, Cemiplimab's trials enrolled 60 people — anything larger?
Median enrolment
60
Largest enrolment
5000
Registered trials counted
201
Q12
What do 152 spontaneous reports say about Cemiplimab — 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.
Cemiplimab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 152 reaction mentions were counted: pyrexia 27; acute kidney injury 22; infusion related reaction 16; pneumonitis 16. open-targets-adr · CHEMBL4297723 · 2026-06-24
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pyrexia
27
acute kidney injury
22
infusion related reaction
16
pneumonitis
16
hepatitis
15
hepatocellular injury
13
4 more recorded rows
interstitial lung disease
12
adrenal insufficiency
11
cholestasis
10
colitis
10
recorded 2026-06-24 · last checked 2026-09-04
Q13
What is recorded about Cemiplimab and mTOR?
"After cross-taper to a mammalian target of rapamycin (mTOR) inhibitor and pulsed dose corticosteroids (prednisone 40 mg once daily, the day before and on days 1-3 of each cycle, followed by 20 mg once daily on days 4-6, then 10 mg once daily until the day before each subsequent cycle), patients received cemiplimab 350 mg intravenously…" — where Cemiplimab and mTOR appear together. Europe PMC · pathway abstract search · 2024-01-22
mTOR; PMID 38252908, 32969143
Show the evidence
mTOR
PMID 38252908
"After cross-taper to a mammalian target of rapamycin (mTOR) inhibitor and pulsed dose corticosteroids (prednisone 40 mg once daily, the day before and on days 1-3 of each cycle, followed by 20 mg once daily on days 4-6, then 10 mg once daily until the day before each subsequent cycle), patients received cemiplimab 350 mg intravenously once every 3 weeks for up to 2 years and were assessed for…"
PMID 32969143
"At a median of 10.8 years (range, 6.6-18.1) post-transplant, six were treated with cemiplimab and one with pembrolizumab after minimizing calcineurin inhibitors (CNIs) or conversion of CNI to mammalian target of rapamycin (mTOR) inhibitors."
recorded 2024-01-22 · last checked 2026-09-04
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