This page shows what was measured, who it was measured in, and what that does not settle.
What Avelumab does in the body
Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) [see Clinical Studies (14
From the FDA-approved label: PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. 1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. 1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses.
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 · KXG2PJ551I · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 104 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.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
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.
Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
✗ The study did not show it
Who was studied
NCT01772004
How many people
1756
Study design
Phase 1
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 Drugs@FDA · a recorded source, not a stored snapshot
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) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
✗ The study did not show it
Who was studied
NCT02576574
How many people
1214
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 Drugs@FDA · a recorded source, not a stored snapshot
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) as Assessed by Blinded Independent Central Review (BICR)
✗ The study did not show it
Who was studied
NCT02718417
How many people
998
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 Drugs@FDA · a recorded source, not a stored snapshot
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) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants
✗ The study did not show it
Who was studied
NCT02684006
How many people
886
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 Drugs@FDA · a recorded source, not a stored snapshot
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 Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)
✗ The study did not show it
Who was studied
NCT03547973
How many people
827
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 Drugs@FDA · a recorded source, not a stored snapshot
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) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)
✗ The study did not show it
Who was studied
NCT02395172
How many people
792
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 Drugs@FDA · a recorded source, not a stored snapshot
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.10 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.
■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 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.
progression free survival in phase 2 cohort 2b
overall survival
overall survival in pd l1 positive
progression free survival at 6 months
disease free survival
progression free survival
overall progression free survival
relapse free survival
progression free survival according to recist v1 1 criteria
partial remission
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 (30)
dose escalation cohorts number of dose limiting toxicities
part b durable response rate
confirmed objective response in pf 06747775 200 qd group
dose limiting toxicities
dose limiting toxicities phase 1b
objective response phase 2
evidence of response based on median time to new metastasis
lead in phase target occupancy at day 2 of cycle 1
lead in phase target occupancy at day 1 of cycle 2
cumulative incidence of achieving a deep molecular response
recommended phase ii dose
maximum tolerated dose
objective response rate
overall response rate
response
response rate
safety and tolerability
adverse events
incidence of adverse events
objective response rate by recist version 1 1
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. 6.1 days
Read from the label, which states: “The total systemic clearance (% CV) was 0.59 L/day (25%) and the terminal half-life (% CV) was 6.1 days (92%) in patients who received a dose of 10 mg/kg every 2 weeks.”
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.
BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. ( 1.1, 14.1 ) Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy.
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: “Safety and effectiveness of BAVENCIO have not been established in pediatric patients less than 12 years of age.”
US prescribing information · 5cd725a1-2fa4-408a-a651-57a7b84b2118 · read 2026-08-30
On older people, the label states: “Metastatic Merkel Cell Carcinoma Of the 204 patients with MCC who received BAVENCIO in the JAVELIN Merkel 200 trial, 78% were 65 years or older and 43% were 75 years or older.”
US prescribing information · 5cd725a1-2fa4-408a-a651-57a7b84b2118 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action, BAVENCIO can cause fetal harm when administered to a pregnant woman.”
US prescribing information · 5cd725a1-2fa4-408a-a651-57a7b84b2118 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of avelumab in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 5cd725a1-2fa4-408a-a651-57a7b84b2118 · 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
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
✎ 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 injectable, injection, solution, concentrate, given by the intravenous, injection 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.
Avelumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 401 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
disease progression — 82 reaction mentions
infusion related reaction — 67 reaction mentions
chills — 55 reaction mentions
general physical health deterioration — 37 reaction mentions
interstitial lung disease — 37 reaction mentions
colitis — 28 reaction mentions
pneumonitis — 27 reaction mentions
myositis — 24 reaction mentions
hypothyroidism — 22 reaction mentions
myocarditis — 22 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
1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.
FDA National Drug Code directory · 44087-3535 · read 2026-08-29
They are sold as injection, solution, concentrate, taken intravenous.
FDA National Drug Code directory · 44087-3535 · read 2026-08-29
The regulator's established pharmacologic class for it is antibodies, monoclonal [cs] and programmed death ligand-1 antagonists [moa].
FDA National Drug Code directory · 44087-3535 · 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 · 5cd725a1-2fa4-408a-a651-57a7b84b2118 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 5cd725a1-2fa4-408a-a651-57a7b84b2118 · read 2026-08-29
BAVENCIO is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 200 mg/10 mL (20 mg/mL), clear, colorless to slightly yellow solution in a single-dose vial., recorded as fda label in effect 2026-08-25 in the United States.
US prescribing information · 5cd725a1-2fa4-408a-a651-57a7b84b2118 · 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 Avelumab 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 Avelumab 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)
KXG2PJ551I
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: Written into the record, not signed off.
✗ 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
2 approved applications cover products containing this substance. The earliest was BLA761049, approved 20170323 to EMD SERONO INC.
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
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Recorded evidence blocks (12)
Q2
What did Avelumab's largest trial (2214 people) and its longest (14 years) measure?
2214 people in Avelumab's largest registered study, 14 years in its longest registered window, measuring Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Avelumab After Single Dose. ClinicalTrials.gov · 2026-09-01
165 phase2, 102 phase1, 18 phase3, 13 na or unstated, 6 early phase1, 1 na; NCT02813135; 2031-02; no ageing endpoint recorded. Last human test completed 2026, NCT06412848.
Interpretation These counts include studies where Avelumab 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
165
phase1
102
phase3
18
na or unstated
13
early phase1
6
na
1
1 more recorded row
Last recorded human testNCT06412848
2026-06-30
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Avelumab shown biomarker?
Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Avelumab After Single Dose — the recorded outcome words.
Show the evidence
mouse
mechanism-only
humanNCT02603419
biomarker; Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Avelumab After Single Dose; 248
"The study was ended for strategic reasons and changes in the external environment. The safety profile and risk benefit ratio for PF-0674775 remained unchanged."; 82 of 248 registered studies
Show the evidence
Trial
NCT02349633
terminated; "The study was ended for strategic reasons and changes in the external environment. The safety profile and risk benefit ratio for PF-0674775 remained unchanged."
NCT02554812
terminated; "The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)"
NCT02584634
terminated; "The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)"
NCT02584829
terminated; "Terminated due to loss in funding"
NCT02603419
terminated; "The study was terminated due to lack of recruitment."
NCT02718417
terminated; "The study was terminated based on the results of a planned interim analysis that showed futility of efficacy."
14 further recorded trials
NCT02875613
terminated; "Slow patient accrual"
NCT02951156
terminated; "Study was terminated due to closure of study arms following futility analysis and difficulty in enrolling participants due to evolving treatment landscape"
NCT02952586
terminated; "The trial prematurely terminated as recommended by the E-DMC because the boundary for futility has been crossed."
NCT02953561
terminated; "PDOL request"
NCT02994953
terminated; "The study was terminated due to pre-specified futility criteria met."
NCT03000179
terminated; "Low accrual"
NCT03035630
withdrawn; "Principal investigator left lead institution and efforts to open the protocol at another institution were not successful."
NCT03050554
terminated; "Funding"
NCT03050814
terminated; "Terminated after an unplanned interim efficacy analysis."
NCT03074318
terminated; "Terminated due to PI leaving institution"
NCT03136406
terminated; "Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention"
NCT03167164
withdrawn; "Trial not initiated"
NCT03167177
withdrawn; "Trial not initiated"
NCT03169738
withdrawn; "Trial not initiated"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Avelumab used Avelumab 3 mg/kg — over how long?
9 recorded entries; human; IV; also "Avelumab 3 mg/kg", "Avelumab 10 mg/kg", "Avelumab 20 mg/kg"
Show the evidence
human
NCT01943461
Avelumab 3 mg/kg
NCT01943461
Avelumab 10 mg/kg
NCT01943461
Avelumab 20 mg/kg
NCT03390595
avelumab 10mg/kg with carboplatin/gemcitabine
NCT03523390
Avelumab 3 mg/kg Q2W
NCT03523390
Avelumab 10 mg/kg Q2W
3 more recorded rows
humanNCT03523390
Avelumab 20 mg/kg Q2W
humanNCT03523390
Avelumab 10 mg/kg QW
humanNCT05107427
IV; Avelumab 20 mg/mL Intravenous Solution (IV)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Avelumab's half-life is 6.1 days — which schedules were studied?
6.1 days, the half-life Avelumab's label states. openfda-label · 5cd725a1-2fa4-408a-a651-57a7b84b2118 · 2026-08-30
Show the evidence
half life
6.1 days; The total systemic clearance (% CV) was 0.59 L/day (25%) and the terminal half-life (% CV) was 6.1 days (92%) in patients who received a dose of 10 mg/kg every 2 weeks.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of adverse events, confirmed objective response in pf 06747775 200 qd group and cumulative incidence of achieving a deep molecular response did Avelumab's trials measure?
adverse events, confirmed objective response in pf 06747775 200 qd group and cumulative incidence of achieving a deep molecular response lead 40 outcome terms across Avelumab's trials. ClinicalTrials.gov · 2026-09-01
progression free survival in phase 2 cohort 2b, dose limiting toxicities, overall survival, dose limiting toxicities phase 1b, objective response phase 2 and evidence of response based on median time to new metastasis follow.
Show the evidence
dose escalation cohorts number of dose limiting toxicities
1
part b durable response rate
1
confirmed objective response in pf 06747775 200 qd group
1
progression free survival in phase 2 cohort 2b
1
dose limiting toxicities
1
overall survival
1
14 more recorded rows
dose limiting toxicities phase 1b
1
objective response phase 2
1
evidence of response based on median time to new metastasis
1
lead in phase target occupancy at day 2 of cycle 1
1
lead in phase target occupancy at day 1 of cycle 2
1
overall survival in pd l1 positive
1
cumulative incidence of achieving a deep molecular response
1
recommended phase ii dose
1
maximum tolerated dose
1
objective response rate
1
overall response rate
1
progression free survival at 6 months
1
disease free survival
1
response
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Avelumab's 53 ongoing trials reports first?
Recommended phase II dose (RP2D); Objective Response Rate; latest 2033-06-15
Show the evidence
Trial
NCT02813135
"European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors"; n 472; "Recommended phase II dose (RP2D)"; 2031-02
NCT02912572
"Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer"; n 106; "Objective Response Rate"; 2026-11
NCT02999087
"Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH)"; n 707; "Progression free survival"; 2027-12
NCT03076554
"A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy"; n 56; "Safety and tolerability of Avelumab based on NCI-CTCAE v4.0"; 2028-03-30
NCT03147287
"Palbociclib After CDK and Endocrine Therapy (PACE)"; n 220; "Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment)"; 2026-06-30
NCT03217747
"Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies"; n 173; "Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria)"; 2026-04-30
14 further recorded trials
NCT03252938
"Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors"; n 83; "Feasibility rate"; 2026-09-30
NCT03260023
"Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers"; n 143; "Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies"; 2026-12
NCT03271372
"Adjuvant Avelumab in Merkel Cell Cancer"; n 101; "Relapse-free survival"; 2029-02-18
NCT03391479
"A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy"; n 25; "Objective Response Rate"; 2026-12-31
NCT03414658
"The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer"; n 100; "Progression Free Survival"; 2027-05-31
NCT03498378
"Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma"; n 24; "maximum tolerated dose"; 2025-12-30
NCT03547973
"Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread"; n 502; "Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)"; 2030-04
NCT03573648
"Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer"; n 33; "Clinical Complete Response"; 2026-12-30
NCT03744793
"Pemetrexed and Avelumab in Treating Patients With MTAP-Deficient Metastatic Urothelial Cancer"; n 18; "Overall response rate"; 2027-01-31
NCT03815643
"Avelumab Program Rollover Study"; n 205; "Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for…"; 2026-08-21
NCT03845166
"A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors"; n 325; "Dose-Escalation Stage: MTD/recommended dose for XL092"; 2027-05-31
NCT03944941
"Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer"; n 60; "Prolonging of Progression Free Survival (PFS) on Avelumab and Cetuximab Compared to Avelumab Alone"; 2028-12-01
NCT03964532
"TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer"; n 24; "Quantification of Grade 3 and 4 toxicities (Adverse Events)"; 2027-04
NCT03971409
"Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer"; n 145; "Best Overall Response Rate (BORR)"; 2027-01-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Avelumab could settle lifespan?
NCT03147287 measures Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment), reading out 2026-06-30.
15 open trials; n 220; "Palbociclib After CDK and Endocrine Therapy (PACE)"
Show the evidence
Trial
NCT03147287
"Palbociclib After CDK and Endocrine Therapy (PACE)"; n 220; "Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment)"; 2026-06-30
NCT05327530
"A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)"; n 256; "Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100…"; 2027-01-22
NCT04792073
"Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma"; n 18; "progression free survival"; 2027-03
NCT03414658
"The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer"; n 100; "Progression Free Survival"; 2027-05-31
NCT02999087
"Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH)"; n 707; "Progression free survival"; 2027-12
NCT04261855
"Targeted Therapy and Avelumab in Merkel Cell Carcinoma"; n 19; "Progression Free Survival (PFS) at 12 months"; 2027-12
9 further recorded trials
NCT05947500
"Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial"; n 50; "Composite progression-free survival (PFS)"; 2028-01-01
NCT06225596
"Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)"; n 375; "Cohort 1: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1(RECIST v1.1) by blinded central independent review (BICR) of optimal dose zelenectide pevedotin with pembrolizumab versus chemotherapy"; 2028-03
NCT03944941
"Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer"; n 60; "Prolonging of Progression Free Survival (PFS) on Avelumab and Cetuximab Compared to Avelumab Alone"; 2028-12-01
NCT03271372
"Adjuvant Avelumab in Merkel Cell Cancer"; n 101; "Relapse-free survival"; 2029-02-18
NCT05092958
"Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study"; n 654; "Overall survival (OS)"; 2029-07-15
NCT06518564
"Avelumab and M1774 in ARID1A-mutated Endometrial Cancer"; n 25; "Progression Free Survival at 6 months (PFS6)"; 2029-08-31
NCT04291885
"Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma"; n 122; "Recurrence-free survival (RFS)"; 2030-04-30
NCT04637594
"Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy"; n 3; "Overall Survival (OS) Rate at 12 Months"; 2030-09
NCT05327686
"Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial"; n 240; "Nephrectomy and radiographic progression-free survival (nrPFS)"; 2033-06-15
Q10
Which 36 trials of Avelumab posted no result?
Posted no result
36 of 36 completed trials
Registrations
NCT03291314, NCT03403777, NCT03258398, NCT03147404, NCT02938273 and NCT03389126, and 30 more
Completion dates
oldest 2019-01-01; newest 2024-08-26
Show the evidence
Trial
NCT03291314
2019-01-01
NCT03403777
2019-02-28
NCT03258398
2019-05-13
NCT03147404
2019-07-22
NCT02938273
2019-09-30
NCT03389126
2020-01-31
14 further recorded trials
NCT03278405
2020-03-12
NCT03158883
2020-06-24
NCT04898751
2020-08-31
NCT03152565
2020-10-05
NCT03174405
2021-07-16
NCT03891238
2021-09-15
NCT03056599
2021-09-22
NCT03341806
2021-10-13
NCT04561336
2021-11-14
NCT03200587
2021-11-25
NCT03514719
2021-12-02
NCT03352934
2022-02-18
NCT03270176
2022-03-22
NCT04065555
2022-07-20
Q11
At the median, Avelumab's trials enrolled 30 people — anything larger?
Median enrolment
30
Largest enrolment
2214
Registered trials counted
247
Q12
What do 401 spontaneous reports say about Avelumab — 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.
Avelumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 401 reaction mentions were counted: disease progression 82; infusion related reaction 67; chills 55; general physical health deterioration 37. open-targets-adr · CHEMBL3833373 · 2026-06-24
Show the evidence
disease progression
82
infusion related reaction
67
chills
55
general physical health deterioration
37
interstitial lung disease
37
colitis
28
4 more recorded rows
pneumonitis
27
myositis
24
hypothyroidism
22
myocarditis
22
recorded 2026-06-24 · last checked 2026-09-04
Q13
What is recorded about Avelumab and mTOR?
"A high Notch-score was linked with more "resting"/"anti-inflammatory" rather than "activated"/"pro-inflammatory" tumor-infiltrating immune cells, inactivated immune pathways, and scarce any benefits from ICI-based therapies over VEGFR/mTOR inhibitors in the JAVELIN Renal 101 (avelumab plus axitinib vs. sunitinib) and the…" — where Avelumab and mTOR appear together. Europe PMC · pathway abstract search · 2023-10-21
mTOR; PMID 38179060, 37046008
Show the evidence
mTOR
PMID 38179060
"A high Notch-score was linked with more "resting"/"anti-inflammatory" rather than "activated"/"pro-inflammatory" tumor-infiltrating immune cells, inactivated immune pathways, and scarce any benefits from ICI-based therapies over VEGFR/mTOR inhibitors in the JAVELIN Renal 101 (avelumab plus axitinib vs. sunitinib) and the CheckMate-009/010/025 trials (nivolumab vs. everolimus)."
PMID 37046008
"A high BAP1-score indicated remarkable PFS benefits from ICI-based immunotherapies over angiogenic/mTOR inhibitors (avelumab plus axitinib vs. sunitinib: HR = 0.55, 95% CI 0.43-0.70, P < 0.001; nivolumab vs. everolimus: HR = 0.72, 95% CI 0.52-1.00, P = 0.045), while these benefits were negligible in the low BAP1-score subgroup (HR = 1.16 and 1.02, respectively)."
recorded 2023-10-21 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 8 source rows
✓ no critical contamination: no quarantine open
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✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.