Avelumab
- Generic Name
- Avelumab
- Brand Names
- Bavencio
- Drug Type
- Biotech
- CAS Number
- 1537032-82-8
- Unique Ingredient Identifier
- KXG2PJ551I
- Background
Avelumab is a human IgG1 lambda monoclonal antibody that binds programmed cell death ligand-1 (PD-L1) to block its interaction with its receptors found on T cells and antigen-presenting cells. Avelumab was first approved by the FDA on March 23, 2017. On September 18 and December 18 of the same year, it was also granted approval by EMA and Health Canada, respectively. It is used in the treatment of Merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma.
- Indication
Avelumab is indicated for the treatment of adults with metastatic Merkel cell carcinoma (MCC). In the US, it is also used in patients 12 years and older.
It is also indicated as the maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (UC), which has not progressed with first-line platinum-containing chemotherapy. In the US, avelumab is also indicated to treat locally advanced or metastatic UC with disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Avelumab is indicated, in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma (RCC).
- Associated Conditions
- Advanced Renal Cell Carcinoma, Metastatic Urothelial Cancer, Locally advanced Urothelial Carcinoma, Metastatic Merkel Cell Carcinoma (MCC)
- Associated Therapies
- First Line Chemotherapy, Maintenance therapy
FOLFIRI + Cetuximab + Avelumab RAS Wild-type CRC
- Conditions
- Treatment Related Cancer
- Interventions
- First Posted Date
- 2022-02-01
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- Target Recruit Count
- 57
- Registration Number
- NCT05217069
- Locations
- 🇩🇪
Ludwig Maximilians University, Munich, Germany
Avelumab, Palbociclib and Axitinib in Advanced RCC
- Conditions
- Advanced Clear Cell Renal Cell Carcinoma
- Interventions
- First Posted Date
- 2022-01-04
- Last Posted Date
- 2023-09-07
- Lead Sponsor
- Bradley A. McGregor, MD
- Registration Number
- NCT05176288
Trial of Immunotherapy With Avelumab and Pepinemab As Second Line For Patients With Metastatic Pancreatic Adenocarcinoma
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Interventions
- First Posted Date
- 2021-11-01
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- Vaccinex Inc.
- Target Recruit Count
- 48
- Registration Number
- NCT05102721
- Locations
- 🇺🇸
University of Rochester Medical Center, Rochester, New York, United States
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
- Conditions
- Metastatic Bladder Urothelial CarcinomaAdvanced Renal Pelvis Urothelial CarcinomaAdvanced Ureter Urothelial CarcinomaStage III Urethral Cancer AJCC v8Metastatic Renal Pelvis Urothelial CarcinomaStage IV Renal Pelvis and Ureter Cancer AJCC v8Stage IV Renal Pelvis Cancer AJCC v8Stage IV Ureter Cancer AJCC v8Stage IV Urethral Cancer AJCC v8Advanced Bladder Urothelial Carcinoma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- First Posted Date
- 2021-10-26
- Last Posted Date
- 2025-03-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 654
- Registration Number
- NCT05092958
- Locations
- 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸Cleveland Clinic-Weston, Weston, Florida, United States
🇺🇸Rush - Copley Medical Center, Aurora, Illinois, United States
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
- Conditions
- Central Nervous System Tumors
- Interventions
- First Posted Date
- 2021-10-18
- Last Posted Date
- 2025-04-15
- Target Recruit Count
- 17
- Registration Number
- NCT05081180
- Locations
- 🇨🇦
CHU Sainte-Justine, Montréal, Canada
🇨🇦The Hospital for Sick Children, Toronto, Canada
🇫🇷CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique, Angers Cedex 9, France
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
- Conditions
- Advanced MalignanciesNSCLCOvarian CancerUrothelial CancerSolid Tumors
- Interventions
- First Posted Date
- 2021-09-28
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 67
- Registration Number
- NCT05059522
- Locations
- 🇺🇸
Highlands Oncology Group, PA, Springdale, Arkansas, United States
🇷🇺Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary", Omsk, Omskaya Oblast', Russian Federation
🇺🇸MSK Monmouth, Middletown, New Jersey, United States
Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)
- First Posted Date
- 2021-08-19
- Last Posted Date
- 2023-12-06
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 48
- Registration Number
- NCT05012865
- Locations
- 🇯🇵
Osaka University Hospital, Suita-city, Osaka, Japan
🇯🇵Jichi Medical University Saitama Medical Center, Saitama City, Saitama, Japan
🇯🇵Kurume University Hospital, Kurume, Fukuoka, Japan
Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies
- Conditions
- Clinical Stage IV Merkel Cell Carcinoma AJCC v8Advanced Bladder CarcinomaClinical Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Stage III Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IV Bladder Cancer AJCC v8Stage IV Lung Cancer AJCC v8Advanced Lung Non-Small Cell Carcinoma
- Interventions
- First Posted Date
- 2021-05-26
- Last Posted Date
- 2025-03-06
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 19
- Registration Number
- NCT04902040
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
- Conditions
- Myelosuppression AdultBladder CancerUrothelial CarcinomaChemotherapy-induced NeutropeniaMetastatic Bladder Cancer
- Interventions
- First Posted Date
- 2021-05-14
- Last Posted Date
- 2024-03-22
- Lead Sponsor
- G1 Therapeutics, Inc.
- Target Recruit Count
- 92
- Registration Number
- NCT04887831
- Locations
- 🇺🇸
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
🇺🇸Beacon Cancer Center PLLC, Coeur d'Alene, Idaho, United States
🇫🇷Institut Bergonié - Oncologie Médicale et Pédiatrique, Bordeaux cedex, Gironde, France
Testing the Addition of an Anti-Cancer Immunotherapy Drug, Avelumab, to Gemcitabine and Carboplatin Chemotherapy Prior to Surgery in Muscle Invasive Urinary Tract Cancer vs. Surgery Alone in Patients Who Are Not Able to Receive Cisplatin Therapy (SWOG GAP TRIAL)
- Conditions
- Bladder Carcinoma Infiltrating the Muscle of the Bladder WallInfiltrating Renal Pelvis and Ureter Urothelial CarcinomaStage II Bladder Cancer AJCC v8
- Interventions
- Procedure: Therapeutic Conventional Surgery
- First Posted Date
- 2021-05-04
- Last Posted Date
- 2024-12-30
- Lead Sponsor
- SWOG Cancer Research Network
- Target Recruit Count
- 6
- Registration Number
- NCT04871529
- Locations
- 🇺🇸
NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
🇺🇸Illinois CancerCare-Eureka, Eureka, Illinois, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.