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

GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer

Phase 2

Active, not recruiting

Conditions: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: GEN-001
Drug: Avelumab

First Posted Date: 2022-06-15

Last Posted Date: 2023-10-17

Lead Sponsor: Genome & Company

Target Recruit Count: 42

Registration Number: NCT05419362

Locations: 🇰🇷
Ajou University Hospital, Gyeonggi-do, Korea, Republic of
🇰🇷
Asan Medical Center, Seoul, Korea, Republic of
🇰🇷
Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of

and more 2 locations

Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)

Phase 1

Recruiting

Conditions: Metastatic or Locally Advanced Unresectable Solid Tumors

Interventions: Drug: Tuvusertib
Drug: Lartesertib
Drug: Avelumab

First Posted Date: 2022-05-31

Last Posted Date: 2025-05-21

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

Target Recruit Count: 123

Registration Number: NCT05396833

Locations: 🇺🇸
Providence Medical Foundation, Santa Rosa, California, United States
🇺🇸
University of Miami School of Medicine, Miami, Florida, United States
🇺🇸
Augusta University - formerly Georgia Regents University, Augusta, Georgia, United States

and more 17 locations

An Observational Chart Review Study To Describe The Real-World Outcomes And Use Of Avelumab In Combination With Axitinib For Treatment Of Patients With aRCC In The UK

Completed

Conditions: Advanced Renal Cell Carcinoma

Interventions: Drug: avelumab
Drug: axitinib

First Posted Date: 2022-05-27

Last Posted Date: 2023-12-06

Lead Sponsor: Pfizer

Target Recruit Count: 130

Registration Number: NCT05394493

Locations: 🇬🇧
Pfizer Ltd, Sandwich, Kent, United Kingdom

A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

Completed

Conditions: Urothelial Cancer

Interventions: Drug: Avelumab

First Posted Date: 2022-05-09

Last Posted Date: 2024-08-22

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

Target Recruit Count: 106

Registration Number: NCT05366725

Locations: 🇬🇧
University Hospitals Bristol, Bristol, United Kingdom
🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
🇬🇧
University College London Hospital, London, United Kingdom

and more 7 locations

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Study

Phase 2

Recruiting

Conditions: Metastatic Renal Cell Carcinoma
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Unresectable Renal Cell Carcinoma

Interventions: Biological: Avelumab
Drug: Axitinib
Drug: Cabozantinib
Biological: Ipilimumab
Drug: Lenvatinib
Biological: Nivolumab
Biological: Pembrolizumab
Radiation: Stereotactic Ablative Radiotherapy

First Posted Date: 2022-04-14

Last Posted Date: 2025-01-23

Lead Sponsor: NRG Oncology

Target Recruit Count: 240

Registration Number: NCT05327686

Locations: 🇺🇸
Central Maryland Radiation Oncology in Howard County, Columbia, Maryland, United States
🇺🇸
UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie, Maryland, United States
🇺🇸
Beverly Hospital, Beverly, Massachusetts, United States

and more 205 locations

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Phase 2

Active, not recruiting

Conditions: Locally Advanced or Metastatic Urothelial Carcinoma

Interventions: Drug: Avelumab
Drug: NKTR-255
Drug: Sacituzumab Govitecan
Drug: M6223

First Posted Date: 2022-04-14

Last Posted Date: 2025-05-07

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

Target Recruit Count: 256

Registration Number: NCT05327530

Locations: 🇫🇷
Hôpital Henri Mondor - Service d'Oncologie Médicale, Creteil, France
🇫🇷
Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical, Le Mans, France
🇫🇷
Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale, Nîmes, France

and more 92 locations

CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy

Phase 2

Recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Cetuximab
Drug: Avelumab

First Posted Date: 2022-03-22

Last Posted Date: 2024-02-01

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Target Recruit Count: 173

Registration Number: NCT05291156

Locations: 🇮🇹
A.O.U. Ospedali Riuniti, Ancona, Italy
🇮🇹
A.O. San Giuseppe Moscati, Avellino, Italy
🇮🇹
Centro di Riferimento Oncologico (C.R.O.), Aviano, Italy

and more 21 locations

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

Phase 1

Recruiting

Conditions: Advanced Solid Tumor
Metastatic Cancer

Interventions: Drug: AU-007
Drug: Aldesleukin
Drug: Avelumab
Drug: Nivolumab

First Posted Date: 2022-03-04

Last Posted Date: 2025-04-06

Lead Sponsor: Aulos Bioscience, Inc.

Target Recruit Count: 159

Registration Number: NCT05267626

Locations: 🇺🇸
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇦🇺
Southern Oncology Clinical Research Unit, Bedford Park, South Australia, Australia
🇺🇸
START Midwest, Grand Rapids, Michigan, United States

and more 10 locations