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

Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )

Phase 1

Recruiting

Conditions: Small Cell Lung Cancer Extensive Stage
Merkel Cell Carcinoma

Interventions: Drug: 225Ac-SSO110 + SoC
Drug: Atezolizumab
Drug: Durvalumab
Drug: Avelumab
Drug: Pembrolizumab
Drug: Retifanlimab

First Posted Date: 2025-04-22

Last Posted Date: 2025-04-22

Lead Sponsor: Ariceum Therapeutics GmbH

Target Recruit Count: 50

Registration Number: NCT06939036

Locations: 🇺🇸
Biogenix Molecular, Miami, Florida, United States

Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer

Phase 2

Recruiting

Conditions: Urinary Bladder Neoplasms

Interventions: Drug: Avelumab

First Posted Date: 2025-03-25

Last Posted Date: 2025-03-25

Lead Sponsor: Queen Mary University of London

Target Recruit Count: 320

Registration Number: NCT06892860

Locations: 🇪🇸
Adknoma, Madrid, Spain
🇫🇷
Unicancer, Paris, France
🇬🇧
Barts Health NHS Trust, London, United Kingdom

DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.

Phase 4

Recruiting

Conditions: Upper Tract Urothelial Cancer
Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable

Interventions: Drug: Platinum + Gemcitabine
Drug: Avelumab first-line maintenance
Diagnostic Test: NGS test for DDR alterations

First Posted Date: 2025-02-11

Last Posted Date: 2025-02-11

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 135

Registration Number: NCT06820255

Locations: 🇮🇹
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

Study of TPEx Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the H&N

Phase 2

Recruiting

Conditions: Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: Avelumab administration at 10mg/kg
Drug: Cetuximab (Erbitux)

First Posted Date: 2024-10-15

Last Posted Date: 2025-01-15

Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

Target Recruit Count: 70

Registration Number: NCT06640725

Locations: 🇫🇷
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France

Combined AlloStim+Anti-PD-L1 in MSS Metastatic Colorectal Cancer

Phase 2

Not yet recruiting

Conditions: Metastatic Colorectal Cancer

First Posted Date: 2024-08-16

Last Posted Date: 2024-08-16

Lead Sponsor: Mirror Biologics, Inc.

Target Recruit Count: 50

Registration Number: NCT06557278

Locations: 🇺🇸
New York Cancer and Blood Specialists, Shirley, New York, United States
🇺🇸
Mt. Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
🇺🇸
Hirschfield Oncology Center, Brooklyn, New York, United States

Avelumab and M1774 in ARID1A-mutated Endometrial Cancer (Prior IO)

Phase 2

Recruiting

Conditions: Endometrial Cancer
ARID1A Gene Mutation
Recurrent Endometrial Carcinoma

Interventions: Drug: Avelumab
Drug: M1774

First Posted Date: 2024-07-24

Last Posted Date: 2024-11-27

Lead Sponsor: Panagiotis Konstantinopoulos, MD, PhD

Target Recruit Count: 25

Registration Number: NCT06518564

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)

Phase 2

Not yet recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: Avelumab
Drug: Tuvusertib

First Posted Date: 2024-05-22

Last Posted Date: 2024-07-31

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 70

Registration Number: NCT06424717

Locations: 🇩🇪
Please Contact the Communication Center, Darmstadt, Germany
🇺🇸
Please Contact U.S. Medical Information, Rockland, Massachusetts, United States

JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

Active, not recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: Avelumab

First Posted Date: 2024-05-14

Last Posted Date: 2025-05-08

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

Target Recruit Count: 360

Registration Number: NCT06412848

Locations: 🇯🇵
Iwate Medical University Hospital, Shiwa-gun, Iwate, Japan
🇯🇵
Kagawa University Hospital, Kita-gun, Kagawa, Japan
🇯🇵
St. Marianna University Hospital, Kawasaki, Kanagawa, Japan

and more 23 locations

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

Phase 2

Recruiting

Conditions: Small Cell Carcinoma of the Bladder
High Grade Neuroendocrine Tumors of the Urinary Tract

Interventions: Drug: Lurbinectedin
Drug: Avelumab

First Posted Date: 2024-01-29

Last Posted Date: 2025-05-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 45

Registration Number: NCT06228066

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Phase 2

Recruiting

Conditions: Metastatic Urothelial Cancer

Interventions: Drug: BT8009
Drug: Gemcitabine + cisplatin Or carboplatin
Drug: Pembrolizumab
Drug: Avelumab

First Posted Date: 2024-01-26

Last Posted Date: 2025-03-28

Lead Sponsor: BicycleTx Limited

Target Recruit Count: 956

Registration Number: NCT06225596

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
Virginia K. Crosson Cancer Center at St. Jude Medical Center, Fullerton, California, United States
🇺🇸
University of California - Irvine Medical Center, Orange, California, United States

and more 166 locations

Drug Development Updates

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