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

Clinical Trials

Drug Screening Using IMD in Bladder Cancer

Early Phase 1

Not yet recruiting

Conditions: Muscle Invasive Bladder Urothelial Carcinoma

Interventions: Device: Implantable Micro-Device
Drug: Methotrexate
Drug: Carboplatin
Drug: Avelumab
Drug: Paclitaxel
Drug: Vinblastine
Drug: Gemcitabine/Cisplatin I
Drug: Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab
Drug: Gemcitabine/Cisplatin II
Drug: Cisplatin
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Gemcitabine/Carboplatin
Drug: Methotrexate/Vinblastine/Doxorubicin/Cisplatin
Drug: Gemcitabine/Cisplatin/Nivolumab
Drug: Erdafitinib
Drug: Paclitaxel/Docetaxel/Ifosfamide
Drug: Gemcitabine
Drug: Gemcitabine/Carboplatin/Nivolumab
Drug: Enfortumab
Drug: Sacituzumab

First Posted Date: 2024-01-12

Last Posted Date: 2024-01-12

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 18

Registration Number: NCT06204614

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

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

Phase 2

Suspended

Conditions: Unresectable Merkel Cell Carcinoma
Locally Advanced Merkel Cell Carcinoma
Metastatic Merkel Cell Carcinoma
Refractory Merkel Cell Carcinoma
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8

Interventions: Procedure: Biopsy Procedure
Drug: Avelumab
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Drug: Tuvusertib

First Posted Date: 2023-07-17

Last Posted Date: 2025-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 50

Registration Number: NCT05947500

Locations: 🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
🇺🇸
Keck Medicine of USC Koreatown, Los Angeles, California, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States

and more 47 locations

A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer

Terminated

Conditions: Bladder Tumors
Urothelial Carcinoma
Urinary Bladder Neoplasms
Bladder Cancer

Interventions: Drug: Avelumab first-line maintenance

First Posted Date: 2023-01-26

Last Posted Date: 2024-04-24

Lead Sponsor: Pfizer

Target Recruit Count: 150

Registration Number: NCT05699135

Locations: 🇨🇦
Bayshore Specialty Rx, Mississauga, Ontario, Canada

SOGUG-AVELUMAB_RWD

Completed

Conditions: Metastatic Urothelial Carcinoma

First Posted Date: 2023-01-26

Last Posted Date: 2024-02-29

Lead Sponsor: Spanish Oncology Genito-Urinary Group

Target Recruit Count: 125

Registration Number: NCT05700344

Locations: 🇪🇸
Hospital Universitario Basurto, Bilbao, Spain
🇪🇸
Complejo Hospitalario Torrecárdenas, Almería, Spain
🇪🇸
Hospital Universitario de Burgos, Burgos, Spain

and more 19 locations

Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer

Phase 1

Not yet recruiting

Conditions: Advanced Urothelial Carcinoma

Interventions: Drug: copanlisib
Drug: Avelumab

First Posted Date: 2023-01-18

Last Posted Date: 2025-01-10

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 29

Registration Number: NCT05687721

Locations: 🇺🇸
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States

Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)

Completed

Conditions: Renal Cell Carcinoma

Interventions: Drug: avelumab
Drug: axitinib

First Posted Date: 2022-12-14

Last Posted Date: 2025-03-28

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 171

Registration Number: NCT05650164

Locations: 🇯🇵
Osaka University Hospital, Suita-city, Osaka, Japan
🇯🇵
Hiroshima University Hospital, Hiroshima, Japan
🇯🇵
Kindai University Hospital, Osakasayama, Osaka, Japan

and more 16 locations

Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer

Phase 2

Recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: Avelumab

First Posted Date: 2022-10-31

Last Posted Date: 2023-09-08

Lead Sponsor: Erasmus Medical Center

Target Recruit Count: 64

Registration Number: NCT05600127

Locations: 🇳🇱
Amphia ziekenhuis, Breda, Brabant, Netherlands
🇳🇱
Jeroen Bosch ziekenhuis, Den Bosch, Brabant, Netherlands
🇳🇱
Erasmus MC, Rotterdam, Zuid Holland, Netherlands

and more 1 locations

Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy

Phase 2

Withdrawn

Conditions: Metastatic Cancer
Urothelial Carcinoma

Interventions: Drug: avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin

First Posted Date: 2022-10-10

Last Posted Date: 2024-08-01

Lead Sponsor: AdventHealth

Registration Number: NCT05574504

Locations: 🇺🇸
AdventHealth Cancer Institute, Orlando, Florida, United States

A Study of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer

Terminated

Conditions: Bladder Cancer

Interventions: Drug: Avelumab

First Posted Date: 2022-10-05

Last Posted Date: 2023-07-13

Lead Sponsor: Pfizer

Target Recruit Count: 19

Registration Number: NCT05568407

Locations: 🇧🇷
Hospital Moinhos de Vento, Porto Alegre, RIO Grande DO SUL, Brazil
🇧🇷
Hospital Mãe de Deus/Aesc, Porto Alegre, RIO Grande DO SUL, Brazil
🇧🇷
Hospital Alemão Oswaldo Cruz, Sao Paulo, SP, Brazil

and more 4 locations

A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread

Completed

Conditions: Urothelial Carcinoma

Interventions: Drug: Avelumab

First Posted Date: 2022-06-24

Last Posted Date: 2025-04-01

Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Target Recruit Count: 79

Registration Number: NCT05431777

Locations: 🇯🇵
Akita University Hospital, Akita, Japan
🇯🇵
Asahi General Hospital, Asahi, Chiba, Japan
🇯🇵
Ogaki Municipal Hospital, Ogaki, Gifu, Japan

and more 13 locations

Drug Development Updates

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