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

A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients with Metastatic Cancers

Phase 1

Active, not recruiting

Conditions: NSCLC
Myelofibrosis
Non-Hodgkin Lymphoma, Adult
Solid Tumor, Adult
Uveal Melanoma

Interventions: Drug: IOA-244
Drug: Ruxolitinib
Drug: Avelumab Injection
Drug: Pemetrexed
Drug: Cisplatin

First Posted Date: 2020-03-31

Last Posted Date: 2025-03-20

Lead Sponsor: iOnctura

Target Recruit Count: 210

Registration Number: NCT04328844

Locations: 🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
🇮🇹
Humanitas Research Hospital, Rozzano, Milan, Italy
🇮🇹
Medical Oncology and Immunotherapy Unit, University Hospital of Siena, Siena, Italy

Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma

Phase 2

Terminated

Conditions: Urothelial Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Atezolizumab
Drug: Durvalumab
Drug: Nivolumab
Drug: Avelumab

First Posted Date: 2020-03-26

Last Posted Date: 2025-02-25

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 4

Registration Number: NCT04322643

Locations: 🇺🇸
Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Neuroendocrine Tumors
Merkel Cell Carcinoma, Stage I
Merkel Cell Carcinoma, Stage II
Merkel Cell Carcinoma
Carcinoma Neuroendocrine Skin
Merkel Cell Carcinoma, Stage III

Interventions: Drug: Placebo
Drug: Avelumab

First Posted Date: 2020-03-02

Last Posted Date: 2025-04-03

Lead Sponsor: Melanoma and Skin Cancer Trials Limited

Target Recruit Count: 122

Registration Number: NCT04291885

Locations: 🇦🇺
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
🇦🇺
Chris O'Brien Lifehouse, Sydney, New South Wales, Australia
🇦🇺
Melanoma Institute Australia, Sydney, New South Wales, Australia

and more 17 locations

Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors

Phase 1

Active, not recruiting

Conditions: Metastatic Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm

Interventions: Drug: Avelumab
Drug: Berzosertib

First Posted Date: 2020-02-12

Last Posted Date: 2025-02-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT04266912

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

Targeted Therapy and Avelumab in Merkel Cell Carcinoma

Phase 1

Recruiting

Conditions: Metastatic Merkel Cell Carcinoma

Interventions: Drug: Avelumab
Radiation: External Beam Radiation Therapy (EBRT)
Radiation: Lutetium-177 (177Lu)-DOTATATE

First Posted Date: 2020-02-10

Last Posted Date: 2025-02-14

Lead Sponsor: Melanoma and Skin Cancer Trials Limited

Target Recruit Count: 19

Registration Number: NCT04261855

Locations: 🇦🇺
Mid North Coast Cancer Institute - Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia
🇦🇺
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
🇦🇺
Gosford Hospital, Gosford, New South Wales, Australia

and more 7 locations

Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas

Phase 1

Active, not recruiting

Conditions: Sarcoma
Advanced Sarcoma
High Grade Sarcoma
Leiomyosarcoma
Undifferentiated Pleomorphic Sarcoma
Myxofibrosarcoma
Dedifferentiated Liposarcoma

Interventions: Drug: DCC-3014
Drug: Avelumab

First Posted Date: 2020-01-27

Last Posted Date: 2025-05-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 32

Registration Number: NCT04242238

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study

Phase 2

Active, not recruiting

Conditions: Breast Cancer Metastatic

Interventions: Drug: Paclitaxel
Biological: Pelareorep
Drug: Avelumab

First Posted Date: 2020-01-02

Last Posted Date: 2025-01-16

Lead Sponsor: Oncolytics Biotech

Target Recruit Count: 48

Registration Number: NCT04215146

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States

and more 15 locations

A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

Phase 2

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: Avelumab
Drug: Lansoprazole
Drug: Aspirin

First Posted Date: 2019-12-05

Last Posted Date: 2023-05-17

Lead Sponsor: The Christie NHS Foundation Trust

Target Recruit Count: 42

Registration Number: NCT04188119

Combination Treatment (Talazoparib Plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation (A LUNG-MAP Treatment Trial)

Phase 2

Active, not recruiting

Conditions: Stage IVB Lung Cancer AJCC v8
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Advanced Lung Non-Squamous Non-Small Cell Carcinoma
Stage IVA Lung Cancer AJCC v8

Interventions: Drug: Avelumab
Drug: Talazoparib
Drug: Talazoparib Tosylate

First Posted Date: 2019-11-22

Last Posted Date: 2024-06-04

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 47

Registration Number: NCT04173507

Locations: 🇺🇸
Parkview Regional Medical Center, Fort Wayne, Indiana, United States
🇺🇸
Palo Alto Medical Foundation-Camino Division, Mountain View, California, United States
🇺🇸
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States

and more 322 locations

Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Phase 1

Recruiting

Conditions: Locally Advanced Malignant Solid Neoplasm
Locally Advanced Unresectable Cholangiocarcinoma
Locally Advanced Unresectable Gallbladder Carcinoma
Locally Advanced Unresectable Malignant Solid Neoplasm
Metastatic Cholangiocarcinoma
Metastatic Gallbladder Carcinoma
Metastatic Malignant Solid Neoplasm
Stage III Gallbladder Cancer AJCC v8
Stage IV Gallbladder Cancer AJCC v8
Unresectable Malignant Solid Neoplasm

Interventions: Drug: Avelumab
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Radiation: Hypofractionated Radiation Therapy
Drug: Peposertib

First Posted Date: 2019-08-28

Last Posted Date: 2025-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 103

Registration Number: NCT04068194

Locations: 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
🇺🇸
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

and more 41 locations

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