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

Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma

Phase 2

Terminated

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Axitinib
Drug: Avelumab
Drug: Bavituximab

First Posted Date: 2022-02-21

Last Posted Date: 2023-05-03

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 1

Registration Number: NCT05249569

Locations: 🇺🇸
The University of Texas Southwestern Medical Center, Dallas, Texas, United States

Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1

Phase 1

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma
Melanoma

Interventions: Biological: TILT-123
Drug: Avelumab

First Posted Date: 2022-02-03

Last Posted Date: 2024-03-19

Lead Sponsor: TILT Biotherapeutics Ltd.

Target Recruit Count: 15

Registration Number: NCT05222932

Locations: 🇫🇮
Docrates Cancer Center, Helsinki, Finland
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

FOLFIRI + Cetuximab + Avelumab RAS Wild-type CRC

Phase 2

Active, not recruiting

Conditions: Treatment Related Cancer

Interventions: Drug: 5-FU
Drug: Folinic Acid
Drug: Irinotecan
Drug: Cetuximab
Drug: Avelumab

First Posted Date: 2022-02-01

Last Posted Date: 2023-11-14

Lead Sponsor: Ludwig-Maximilians - University of Munich

Target Recruit Count: 57

Registration Number: NCT05217069

Locations: 🇩🇪
Ludwig Maximilians University, Munich, Germany

Avelumab, Palbociclib and Axitinib in Advanced RCC

Phase 2

Withdrawn

Conditions: Advanced Clear Cell Renal Cell Carcinoma

Interventions: Drug: Axitinib
Drug: Palbociclib
Drug: Avelumab

First Posted Date: 2022-01-04

Last Posted Date: 2023-09-07

Lead Sponsor: Bradley A. McGregor, MD

Registration Number: NCT05176288

Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study

Phase 3

Active, not recruiting

Conditions: Metastatic Bladder Urothelial Carcinoma
Advanced Renal Pelvis Urothelial Carcinoma
Advanced Ureter Urothelial Carcinoma
Stage III Urethral Cancer AJCC v8
Metastatic Renal Pelvis Urothelial Carcinoma
Stage IV Renal Pelvis and Ureter Cancer AJCC v8
Stage IV Renal Pelvis Cancer AJCC v8
Stage IV Ureter Cancer AJCC v8
Stage IV Urethral Cancer AJCC v8
Advanced Bladder Urothelial Carcinoma

Interventions: Drug: Avelumab
Procedure: Biospecimen Collection
Procedure: Bone Scan
Drug: Cabozantinib S-malate
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2021-10-26

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 654

Registration Number: NCT05092958

Locations: 🇺🇸
Cancer Hematology Centers - Flint, Flint, Michigan, United States
🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸
Sutter Auburn Faith Hospital, Auburn, California, United States

and more 273 locations

Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors

Phase 1

Active, not recruiting

Conditions: Central Nervous System Tumors

Interventions: Drug: Avelumab
Drug: Lenvatinib

First Posted Date: 2021-10-18

Last Posted Date: 2025-01-08

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

Target Recruit Count: 17

Registration Number: NCT05081180

Locations: 🇨🇦
CHU Sainte-Justine, Montréal, Canada
🇨🇦
The Hospital for Sick Children, Toronto, Canada
🇫🇷
CHU Angers - Hôpital Hôtel Dieu - Service de Cancérologie Pédiatrique, Angers Cedex 9, France

and more 6 locations

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

Phase 3

Active, not recruiting

Conditions: Advanced Malignancies
NSCLC
Ovarian Cancer
Urothelial Cancer
Solid Tumors

Interventions: Drug: Avelumab
Drug: CMP 001
Drug: Lorlatanib
Drug: Talazoparib
Drug: Pemetrexed
Drug: Axitinib
Drug: Utomilumab
Drug: PF04518600

First Posted Date: 2021-09-28

Last Posted Date: 2024-11-13

Lead Sponsor: Pfizer

Target Recruit Count: 67

Registration Number: NCT05059522

Locations: 🇺🇸
Highlands Oncology Group, PA, Springdale, Arkansas, United States
🇷🇺
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary", Omsk, Omskaya Oblast', Russian Federation
🇺🇸
MSK Monmouth, Middletown, New Jersey, United States

and more 66 locations

Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)

Completed

Conditions: Renal Cell Carcinoma

Interventions: Drug: avelumab
Drug: axitinib

First Posted Date: 2021-08-19

Last Posted Date: 2023-12-06

Lead Sponsor: Pfizer

Target Recruit Count: 48

Registration Number: NCT05012865

Locations: 🇯🇵
Osaka University Hospital, Suita-city, Osaka, Japan
🇯🇵
Jichi Medical University Saitama Medical Center, Saitama City, Saitama, Japan
🇯🇵
Kurume University Hospital, Kurume, Fukuoka, Japan

and more 9 locations

Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies

Phase 1

Active, not recruiting

Conditions: Clinical Stage IV Merkel Cell Carcinoma AJCC v8
Advanced Bladder Carcinoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
Pathologic Stage IIID Cutaneous Melanoma AJCC v8
Stage III Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Bladder Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Advanced Lung Non-Small Cell Carcinoma

Interventions: Biological: Atezolizumab
Drug: Avelumab
Biological: Durvalumab
Biological: Nivolumab
Biological: Pembrolizumab
Drug: Plinabulin
Radiation: Radiation Therapy

First Posted Date: 2021-05-26

Last Posted Date: 2024-12-05

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 19

Registration Number: NCT04902040

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

Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

Phase 2

Terminated

Conditions: Myelosuppression Adult
Bladder Cancer
Urothelial Carcinoma
Chemotherapy-induced Neutropenia
Metastatic Bladder Cancer

Interventions: Drug: Gemcitabine
Drug: Trilaciclib
Drug: Cisplatin
Drug: Carboplatin
Drug: Avelumab

First Posted Date: 2021-05-14

Last Posted Date: 2024-03-22

Lead Sponsor: G1 Therapeutics, Inc.

Target Recruit Count: 92

Registration Number: NCT04887831

Locations: 🇺🇸
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
🇺🇸
Beacon Cancer Center PLLC, Coeur d'Alene, Idaho, United States
🇫🇷
Institut Bergonié - Oncologie Médicale et Pédiatrique, Bordeaux cedex, Gironde, France

and more 31 locations

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