Avelumab

Generic Name: Avelumab

Brand Names: Bavencio

Drug Type: Biotech

Chemical Formula: -

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

KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer

Phase 1

Terminated

Conditions: Urothelial Carcinoma

Interventions: Drug: KHK2455
Drug: Avelumab

First Posted Date: 2019-04-16

Last Posted Date: 2024-04-25

Lead Sponsor: Kyowa Kirin, Inc.

Target Recruit Count: 16

Registration Number: NCT03915405

Locations: 🇺🇸
Kyowa Research Site USA005, Iowa City, Iowa, United States
🇺🇸
Kyowa Research Site USA 009, Houston, Texas, United States
🇪🇸
Kyowa Research Site ESP003, Barcelona, Spain

and more 6 locations

AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma

Phase 1

Active, not recruiting

Conditions: Malignant Glioma

Interventions: Drug: IDH1R132H peptide vaccine
Drug: Avelumab

First Posted Date: 2019-03-28

Last Posted Date: 2024-06-05

Lead Sponsor: German Cancer Research Center

Target Recruit Count: 60

Registration Number: NCT03893903

Locations: 🇩🇪
Charité Berlin, Neurosurgery, Berlin, Germany
🇩🇪
University Hospital Frankfurt, Neurooncology, Frankfurt/Main, Germany
🇩🇪
University Hospital Dresden, Neurosurgery, Dresden, Germany

and more 7 locations

Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer

Phase 1

Completed

Conditions: Bladder Cancer

Interventions: Drug: Avelumab
Biological: BCG

First Posted Date: 2019-03-27

Last Posted Date: 2024-02-14

Lead Sponsor: University of Oklahoma

Target Recruit Count: 18

Registration Number: NCT03892642

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

Avelumab as Single Agent in Metastatic or Locally Advanced Urothelial Cancer in Patients Unfit for Cisplatin. The ARIES Study

Phase 2

Completed

Conditions: Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer

Interventions: Drug: Avelumab

First Posted Date: 2019-03-26

Last Posted Date: 2024-02-01

Lead Sponsor: Consorzio Oncotech

Target Recruit Count: 67

Registration Number: NCT03891238

Locations: 🇮🇹
Istituto Europeo di Oncologia, Milano, Italy
🇮🇹
Fondazione Salvatore Maugeri, Pavia, Italy
🇮🇹
Arcispedale Santa Maria Nuova Di Reggio Emilia, Reggio Emilia, Italy

and more 18 locations

A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumors
Advanced Triple Negative Breast Cancer
Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer
Advanced Metastatic Castration-Resistant Prostate Cancer
Advanced Platinum-Resistant Ovarian Cancer

Interventions: Drug: TRX518
Drug: Cyclophosphamide
Drug: Avelumab

First Posted Date: 2019-03-04

Last Posted Date: 2023-11-30

Lead Sponsor: Leap Therapeutics, Inc.

Target Recruit Count: 10

Registration Number: NCT03861403

Locations: 🇺🇸
Horizon Oncology Research, Lafayette, Indiana, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 1 locations

Immunotherapy In Locally Advanced Rectal Cancer

Phase 2

Completed

Conditions: Colon Rectal Cancer

Interventions: Drug: Avelumab
Drug: Capecitabine
Radiation: EXTERNAL---BEAM IRRADIATION 50.4 GY

First Posted Date: 2019-02-26

Last Posted Date: 2023-10-19

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 101

Registration Number: NCT03854799

Locations: 🇮🇹
Policlinico Gemelli, Rome, Italy

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

Phase 1

Active, not recruiting

Conditions: Renal Cell Carcinoma
Metastatic Castration-resistant Prostate Cancer
Colorectal Cancer
Neoplasm Malignant
Hormone Receptor Positive Breast Carcinoma

Interventions: Drug: XL092
Drug: Atezolizumab
Drug: Avelumab

First Posted Date: 2019-02-19

Last Posted Date: 2024-11-19

Lead Sponsor: Exelixis

Target Recruit Count: 325

Registration Number: NCT03845166

Locations: 🇺🇸
Exelixis Clinical Site #84, Los Angeles, California, United States
🇺🇸
Exelixis Clinical Site #71, Stanford, California, United States
🇺🇸
Exelixis Clinical Site #85, Bronx, New York, United States

and more 82 locations

Targeting the Tumor Microenvironment in R/M SCCHN

Phase 1

Conditions: Head and Neck Cancer

Interventions: Drug: Avelumab
Drug: CTX
Radiation: RT

First Posted Date: 2019-02-18

Last Posted Date: 2020-03-03

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 71

Registration Number: NCT03844763

Locations: 🇮🇹
AO Santa Croce e Carle di Cuneo, Cuneo, Italia/cuneo, Italy
🇮🇹
Azienda Ospedaliera S. Croce E Carle Di Cuneo - Cuneo (Cn) Oncologia Medica, Cuneo, Italy