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

Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma

Phase 2

Completed

Conditions: Metastatic Renal Cell Carcinoma
Succinate Dehydrogenase Deficient Renal Cell Carcinoma
Fumarate Hydratase Deficient Renal Cell Carcinoma

Interventions: Drug: Talazoparib
Drug: Avelumab

First Posted Date: 2019-08-28

Last Posted Date: 2024-12-27

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 18

Registration Number: NCT04068831

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 4 locations

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

Phase 1

Recruiting

Conditions: Metastatic Castration-Resistant Prostate Carcinoma
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Neoplasm in the Lymph Nodes
Stage IVB Prostate Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Drug: Avelumab
Procedure: Bone Scan
Procedure: Magnetic Resonance Imaging
Procedure: Computed Tomography
Other: Questionnaire Administration
Radiation: Radium Ra 223 Dichloride
Drug: Peposertib

First Posted Date: 2019-08-28

Last Posted Date: 2025-05-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 90

Registration Number: NCT04071236

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 27 locations

Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

Phase 1

Terminated

Conditions: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions: Drug: avelumab
Drug: Bempegaldesleukin
Drug: talazoparib
Drug: enzalutamide

First Posted Date: 2019-08-09

Last Posted Date: 2021-10-14

Lead Sponsor: Pfizer

Target Recruit Count: 3

Registration Number: NCT04052204

Locations: 🇺🇸
University of Rochester Medical Center, Rochester, New York, United States
🇪🇸
Hospital Universitari Vall d'Hebron, Barcelona, Spain
🇧🇪
GZA Ziekenhuizen campus Sint-Augustinus, Wilrijk, Antwerpen, Belgium

and more 2 locations

Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma

Phase 1

Active, not recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: Avelumab
Drug: AVB-S6-500

First Posted Date: 2019-07-02

Last Posted Date: 2025-02-10

Lead Sponsor: University of Oklahoma

Target Recruit Count: 19

Registration Number: NCT04004442

Locations: 🇺🇸
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States

Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

Phase 2

Completed

Conditions: Recurrent Adenoid Cystic Carcinoma
Metastatic Adenoid Cystic Carcinoma
Progressive Disease

Interventions: Drug: Avelumab
Drug: Axitinib

First Posted Date: 2019-06-19

Last Posted Date: 2024-10-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 40

Registration Number: NCT03990571

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Phase 2

Recruiting

Conditions: Stage IIIB Breast Cancer
Stage III Breast Cancer
Stage IV Breast Cancer
Invasive Breast Carcinoma
Recurrent Breast Carcinoma
Triple-Negative Breast Carcinoma
Unresectable Breast Carcinoma
Stage IIIA Breast Cancer
Stage IIIC Breast Cancer

Interventions: Biological: Anti-OX40 Antibody PF-04518600
Drug: Avelumab
Biological: Utomilumab
Drug: Sacituzumab Govitecan
Drug: Binimetinib
Drug: Liposomal Doxorubicin

First Posted Date: 2019-06-03

Last Posted Date: 2025-05-02

Lead Sponsor: Laura Huppert, MD, BA

Target Recruit Count: 150

Registration Number: NCT03971409

Locations: 🇺🇸
O'Neal Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Georgetown University, Washington, District of Columbia, United States

and more 9 locations

Avelumab + Paclitaxel/ Ramucirumab (RAP) as Second Line Treatment in Gastro-esophageal Adenocarcinoma

Phase 2

Conditions: Gastroesophageal Junction Adenocarcinoma
Adenocarcinoma of the Stomach

Interventions: Drug: Avelumab
Drug: Ramucirumab
Drug: Paclitaxel

First Posted Date: 2019-05-29

Last Posted Date: 2019-06-03

Lead Sponsor: P. C. Thuss-Patience

Target Recruit Count: 59

Registration Number: NCT03966118

Locations: 🇩🇪
Charité Universitätsmedizin Berlin, Berlin, Germany

TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

Phase 1

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Talazoparib
Drug: Avelumab

First Posted Date: 2019-05-28

Last Posted Date: 2025-05-21

Lead Sponsor: Georgetown University

Target Recruit Count: 24

Registration Number: NCT03964532

Locations: 🇺🇸
University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇺🇸
MedStar Georgetown University Hospital, Washington, District of Columbia, United States

Bladder PREserVation by RadioTherapy and Immunotherapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer

Phase 2

Conditions: Non-muscle-invasive Bladder Cancer

Interventions: Drug: Avelumab
Device: Radiotherapy

First Posted Date: 2019-05-15

Last Posted Date: 2019-05-16

Lead Sponsor: Institut Paoli-Calmettes

Target Recruit Count: 67

Registration Number: NCT03950362

Avelumab with or Without Cetuximab in Treating Patients with Advanced Skin Squamous Cell Cancer

Phase 2

Active, not recruiting

Conditions: Skin Squamous Cell Carcinoma
Metastatic Skin Cancer

Interventions: Drug: Avelumab
Drug: Cetuximab

First Posted Date: 2019-05-10

Last Posted Date: 2025-02-18

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 60

Registration Number: NCT03944941

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸
Anchorage Radiation Therapy Center, Anchorage, Alaska, United States

and more 425 locations

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