BAVENCIO (avelumab)
BAVENCIO is indicated for the treatment of Metastatic Merkel cell carcinoma in adults and pediatric patients 12 years and older; Maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy; Locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy; Locally advanced or metastatic urothelial carcinoma with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; First-line treatment of advanced renal cell carcinoma in combination with axitinib.
How BAVENCIO Works
Avelumab binds to PD-L1, a protein expressed on tumor cells that suppresses the immune system by interacting with receptors on T cells. By blocking the interaction between PD-L1 and the PD-1 and B7.1 receptors, the drug releases the inhibitory effects on T-cell activity and proliferation. This mechanism restores the body's anti-tumor immune response and allows for increased cytokine production. Additionally, the drug has been shown to induce antibody-dependent cell-mediated cytotoxicity against target cells in vitro.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-03-23
- Patent Cliff
- 2024
- Routes
- INTRAVENOUS, INJECTION
- Dosage Forms
- INJECTABLE
BAVENCIO Approval History
What BAVENCIO Treats
5 indicationsBAVENCIO is approved for 5 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Merkel cell carcinoma in adults and pediatric patients 12 years and older
- Maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy
- Locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy
- Locally advanced or metastatic urothelial carcinoma with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- First-line treatment of advanced renal cell carcinoma in combination with axitinib
BAVENCIO Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
BAVENCIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BAVENCIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BAVENCIO treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
187 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04071236 | NCI-2019-05620 NCI-2019-05620, 202006062 | Ph 1, Ph 2 | recruiting | Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy |
| NCT05947500 | NCI-2023-05259 NCI-2023-05259, 10592 | Ph 2 | active not recruiting | 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 |
| NCT05092958 | NCI-2021-11166 NCI-2021-11166, A032001 | Ph 3 | active not recruiting | Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study |
| NCT04068194 | NCI-2019-05373 NCI-2019-05373, 052002 | Ph 1, Ph 2 | active not recruiting | Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies |
| NCT03271372 ADAM | 9820 NCI-2017-00998, RG1717054 | Ph 3 | active not recruiting | Adjuvant Avelumab in Merkel Cell Cancer |
| NCT06892860 DISCUS | DISCUS | Ph 2 | recruiting | Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer |
| NCT03217747 results posted | 2017-0014 NCI-2018-01118, 2017-0014 | Ph 1, Ph 2 | active not recruiting | Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies |
| NCT05327686 SAMURAI | NRG-GU012 NCI-2022-02189, NRG-GU012 | Ph 2 | recruiting | Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial |
| NCT05081180 | MS100070_0087 2020-004397-22, 2024-512940-51-00 | Ph 1 | active not recruiting | Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors |
| NCT04902040 results posted | 2020-0296 NCI-2021-03489, 2020-0296 | Ph 1, Ph 2 | terminated | Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies |
| NCT03076554 | 170066 17-C-0066 | Ph 2 | active not recruiting | A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy |
| NCT05327530 | MS100070_0119 2021-003669-36, 2023-510139-12-00 | Ph 2 | active not recruiting | A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) |
| NCT06225596 | BT8009-230 2023-504231-41, U1111-1300-3791 | Ph 2, Ph 3 | active not recruiting | Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) |
| NCT03971409 InCITe | 187519 NCI-2019-01531, TBCRC 047 | Ph 2 | active not recruiting | Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer |
| NCT07110038 | UKT-IKF-DEPECA-1 2025-521644-37-00 | Ph 2 | recruiting | DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma |
| NCT05059522 | B9991046 2023-509466-38-00 | Ph 3 | active not recruiting | Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing |
| NCT04841148 PALAVY | UPCC 01121 IRB# 848471, TBCRC 046 | Ph 2 | recruiting | Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer |
| NCT03964532 | STUDY00000023 | Ph 1, Ph 2 | active not recruiting | TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer |
| NCT04291885 I-MAT | 03.18 | Ph 2 | active not recruiting | Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma |
| NCT04792073 | 20-195 | Ph 2 | active not recruiting | Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma |
| NCT04360941 PAveMenT | CCR4884 | Ph 1 | recruiting | PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer |
| NCT03815643 | MS100070_0176 2018-003711-21, 2024-514274-46-00 | Ph 3 | active not recruiting | Avelumab Program Rollover Study |
| NCT05267626 | CP-AU-007-01 | Ph 1, Ph 2 | recruiting | Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer |
| NCT04261855 GoTHAM | 10.17 | Ph 1, Ph 2 | active not recruiting | Targeted Therapy and Avelumab in Merkel Cell Carcinoma |
| NCT04387084 | 0S-20-1 NCI-2020-01590, 0S-20-1 | Ph 1 | active not recruiting | Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy |
| NCT06228066 | 10001523 001523-C | Ph 2 | recruiting | Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER) |
| NCT04637594 IMAGINE results posted | A031901 NCI-2020-08395, U10CA180821 | Ph 3 | active not recruiting | Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy |
| NCT03573648 ImmunoADAPT | J1836 IRB00164275, WI231034 | Ph 2 | active not recruiting | Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer |
| NCT03547973 TROPHY U-01 | IMMU-132-06 2023-508302-24 | Ph 2 | recruiting | Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread |
| NCT04004442 COAXIN | OU-SCC-COAXIN | Ph 1 | active not recruiting | Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma |
| NCT03719768 | MCC-19648 W1239387 | Ph 1 | completed | Avelumab With Radiotherapy in Patients With Leptomeningeal Disease |
| NCT03006848 results posted | OSTPDL1 Pfizer W1211733 (OSTPDL1), Gateway RESAG | Ph 2 | completed | A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma |
| NCT05396833 | MS201924_0020 2022-500287-35-00 | Ph 1 | active not recruiting | Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320) |
| NCT03252938 INSIGHT | INSIGHT | Ph 1 | active not recruiting | Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors |
| NCT04848519 | STUDY00002186 NCI-2021-00437, WINSHIP5200-20 | Ph 2 | active not recruiting | Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma |
| NCT03944941 | A091802 NCI-2018-02652, U10CA180821 | Ph 2 | active not recruiting | Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer |
| NCT03260023 results posted | TG4001.12 | Ph 1, Ph 2 | active not recruiting | Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers |
| NCT06939036 SANTANA-225 | SAX101 2024-515041-42-00 | Ph 1, Ph 2 | terminated | Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 ) |
| NCT04701918 | 20-531 | Ph 2 | completed | Cryoablation With Pembrolizumab Or Avelumab In Urothelial Carcinoma |
| NCT02813135 ESMART | 2016-000133-40 2016/2396, 2024-514791-40-00 | Ph 1, Ph 2 | recruiting | European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors |
| NCT03744793 | 2018-0576 NCI-2018-02517, 2018-0576 | Ph 2 | active not recruiting | Pemetrexed and Avelumab in Treating Patients With MTAP-Deficient Metastatic Urothelial Cancer |
| NCT06518564 | 24-301 | Ph 2 | recruiting | Avelumab and M1774 in ARID1A-mutated Endometrial Cancer |
| NCT03391479 | ALPACA 17-6013 | Ph 2 | active not recruiting | A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy |
| NCT05419362 | [GNC] GEN001-201 | Ph 2 | completed | GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer |
| NCT02926196 A-Brave | A-BRAVE-Trial 2016-000189-45 | Ph 3 | completed | Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab |
| NCT04188119 IMpALA | CFT / sp123 2018-004121-80, 017NovCC107 | Ph 2 | withdrawn | A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer |
| NCT03575013 | 201804833 | Ph 1 | completed | A Combination of Avelumab and Taxane (AVETAX) for Urothelial Cancer |
| NCT04266912 results posted | 2018-1059 NCI-2019-07598, 2018-1059 | Ph 1, Ph 2 | active not recruiting | Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors |
| NCT03747419 results posted | 18-464 | Ph 2 | terminated | Avelumab and Radiation in Muscle-Invasive Bladder Cancer |
| NCT06557278 COMUNITY | MBI-006-COMUNITY | Ph 2 | withdrawn | Combined AlloStim+Anti-PD-L1 in 4L MSS Metastatic Colorectal Cancer |
Showing 50 of 187 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BAVENCIO FDA Label Details
Indications & Usage
FDA Label (PDF)BAVENCIO is indicated for the treatment of Metastatic Merkel cell carcinoma in adults and pediatric patients 12 years and older; Maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy; Locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy; Locally advanced or metastatic urothelial carcinoma with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; First-line treatment of advanced renal cell carcinoma in combination with axitinib.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment