Drug

Avelumab

Approved · EMA

ClassProgrammed cell death 1 ligand 1 otherEmerging researchLate-stage developmentCooling momentum

Also known as Bavencio.

RxNorm1875534 ChEMBLCHEMBL3833373 ATCL01FF04UNIIKXG2PJ551I

Research papers

Active clinical trials

Programmed cell death 1 ligand 1

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

A Randomized Phase 2 Study of ATR Inhibition in Advanced PD-(L)1-Refractory Merkel Cell Carcinoma: The MATRiX Trial

Clinical trial2026-07-10Results expected Q1 2028 · ClinicalTrials.gov

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Clinical trial2026-07-10Results expected Q1 2031 · ClinicalTrials.gov

A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed On or After Platinum-based Chemotherapy

Clinical trial2026-07-06Results expected Q4 2026 · ClinicalTrials.gov

An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies

Clinical trial2026-06-29Results expected Q3 2026 · ClinicalTrials.gov

A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy

Clinical trial2026-06-25Results expected Q1 2027 · ClinicalTrials.gov

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Clinical trial2026-06-25Results expected Q2 2028 · ClinicalTrials.gov

Early ctDNA and Survival in Metastatic Colorectal Cancer Treated With Immune Checkpoint Inhibitors: A Secondary Analysis of the SAMCO-PRODIGE 54 Randomized Clinical Trial.

Research2025-08-01JAMA oncology

A soluble LAG-3 protein (eftilagimod alpha) and an anti-PD-L1 antibody (avelumab) tested in a phase I trial: a new combination in immuno-oncology.

Research2023-09-22ESMO open

Efficacy and immune-related adverse event associations in avelumab-treated patients.

Research2020-11-01Journal for immunotherapy of cancer

Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.

Research2020-09-18The New England journal of medicine

Approval: Bavencio (EMA)

Regulatory2017-09-18EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Avelumab

Aliases & brands

Bavencio

RxNorm CUI

1875534

ChEMBL ID

CHEMBL3833373

ATC codes

L01FF04

UNII

KXG2PJ551I

Primary mechanism

Programmed cell death 1 ligand 1 other

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Programmed cell death 1 ligand 1

CD274 · Q9NZQ7

OTHERProgrammed cell death 1 ligand 1 other

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2017-09-18

Latest approval

2017-09-18

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2017-09-18Approval

Approval: Bavencio (EMA)

Indication: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the… Show full indication

Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Bavencio is indicated as monotherapy for the first?line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum?based chemotherapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

191 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

191

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 191

Early Phase 14Phase 134Phase 1 / 244Phase 292Phase 316Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial (IMAGINE)

Active, not recruitingPH IIIAlliance for Clinical Trials in Oncologyn=32030

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial of Adjuvant Avelumab (Anti-PDL-1 Antibody) in Merkel Cell Carcinoma Patients With Lymph Node Metastases

Active, not recruitingPH IIIUniversity of Washingtonn=1012029

A Phase III Randomized Trial of Avelumab-cetuximab-Radiotherapy Versus Standards of Care in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Active, not recruitingPH IIIGroupe Oncologie Radiotherapie Tete et Coun=7072027

AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.

Active, not recruitingPH IIIPfizern=772026

An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies

Active, not recruitingPH IIIEMD Serono Research & Development Institute, Inc.n=2052026

Recent completions

Trials that read out recently, adding to the completed evidence base.

EACH: A Randomised Phase II Study Evaluating the Safety and Anti-tumour Activity of the Combination of Avelumab and Cetuximab Relative to Avelumab Monotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Cancer

CompletedPH IIUniversity College, Londonn=162026

A Phase 1b Dose Escalation and Dose Expansion Study of a CSF1R Inhibitor (DCC-3014) Administered Concurrently With an Anti-PD-L1 Antibody (Avelumab) in Patients With Advanced High-grade Sarcoma

CompletedPH IMemorial Sloan Kettering Cancer Centern=322025

The LATENT Trial: Lytic Activation To Enhance Neoantigen-directed Therapy A Study to Evaluate the Feasibility and Efficacy of the Combined Use of Avelumab With Valproic Acid for the Treatment of Virus-associated Cancer

CompletedPH IIAHS Cancer Control Albertan=392025

Phase II Study of AVELUMAB and CETUXIMAB and Modified FOLFOXIRI as Initial Therapy for RAS Wild-type Unresectable Metastatic Colorectal Cancer Patients

CompletedPH IIGruppo Oncologico del Nord-Ovestn=622024

AXEL: Axitinib-Avelumab Combination in Recurrent or Metastatic Nasopharyngeal Cancer: a Multicenter Phase 2 Trial

CompletedPH IIChinese University of Hong Kongn=132024

AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma - a Randomized, Open Label, 3 Arm Multicenter Phase I Trial to Assess Safety, Tolerability and Immunogenicity of IDH1R132H-specific Peptide Vaccine in Combination with Checkpoint Inhibitor Avelumab

CompletedPH IGerman Cancer Research Centern=692024

Research activity

11 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20162025

Most influential

Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.

The New England journal of medicine · 2020 · 1,117 cites

Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial.

The Lancet. Oncology · 2016 · 902 cites

Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.

Annals of oncology : official journal of the European Society for Medical Oncology · 2020 · 319 cites

Efficacy and Safety of First-line Avelumab Treatment in Patients With Stage IV Metastatic Merkel Cell Carcinoma: A Preplanned Interim Analysis of a Clinical Trial.

JAMA oncology · 2018 · 275 cites

Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after ≥1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial.

Journal for immunotherapy of cancer · 2018 · 214 cites

Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial.

Journal for immunotherapy of cancer · 2020 · 123 cites

Related drugs

6 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Cisplatin

Studied across 4 of the same disease areas as Avelumab in the shared literature.

4 shared diseases1 shared paper

Sunitinib

Studied across 4 of the same disease areas as Avelumab in the shared literature.

4 shared diseases1 shared paper

Axitinib

Studied across 3 of the same disease areas as Avelumab in the shared literature.

3 shared diseases1 shared paper

Carboplatin

Studied across 3 of the same disease areas as Avelumab in the shared literature.

3 shared diseases1 shared paper

Deoxycytidine

Studied across 3 of the same disease areas as Avelumab in the shared literature.

3 shared diseases1 shared paper

Gemcitabine

Studied across 2 of the same disease areas as Avelumab in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.