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

Pemetrexed and Avelumab in Treating Patients With MTAP-Deficient Metastatic Urothelial Cancer

Phase 2

Active, not recruiting

Conditions: Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant
Infiltrating Bladder Urothelial Carcinoma with Glandular Differentiation
Infiltrating Bladder Urothelial Carcinoma with Squamous Differentiation
Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant
Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant
Metastatic Urothelial Carcinoma
MTAP Negative

Interventions: Drug: Avelumab
Drug: Pemetrexed

First Posted Date: 2018-11-16

Last Posted Date: 2024-08-27

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 18

Registration Number: NCT03744793

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

Study of Avelumab-M3814 Combinations

Phase 1

Completed

Conditions: Oncology
Solid Tumors

Interventions: Drug: M3814
Drug: Avelumab
Radiation: Radiotherapy

First Posted Date: 2018-10-30

Last Posted Date: 2022-11-30

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

Target Recruit Count: 57

Registration Number: NCT03724890

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa, Florida, United States
🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Mount Sinai - PRIME (10707), Lake Success, New York, United States

and more 5 locations

Avelumab With Radiotherapy in Patients With Leptomeningeal Disease

Phase 1

Completed

Conditions: Leptomeningeal Disease
Leptomeningeal Metastases

Interventions: Drug: Avelumab
Radiation: Whole Brain Radiotherapy

First Posted Date: 2018-10-25

Last Posted Date: 2024-11-27

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 16

Registration Number: NCT03719768

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC

Phase 2

Completed

Conditions: Squamous Non-Small Cell Lung Cancer

Interventions: Drug: Avelumab
Drug: Cetuximab
Drug: Gemcitabine
Drug: Cisplatin
Drug: Carboplatin

First Posted Date: 2018-10-24

Last Posted Date: 2022-06-06

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 43

Registration Number: NCT03717155

Locations: 🇭🇺
Petz Aladar Megyei Oktato Korhaz - Pulmonologiai Osztaly, Gyor, Hungary
🇭🇺
Tudogyogyintezet Torokbalint - Onkopulmonologiai es Jarobeteg centrum, Torokbalint, Hungary
🇪🇸
Hospital Universitari Vall d'Hebron - Dept of Oncology, Barcelona, Spain

and more 17 locations

Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer

Phase 1

Completed

Conditions: Ovarian Cancer

Interventions: Drug: M6620
Drug: Avelumab
Drug: Carboplatin

First Posted Date: 2018-10-12

Last Posted Date: 2020-11-13

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

Target Recruit Count: 3

Registration Number: NCT03704467

Locations: 🇺🇸
The Stamford Hospital, Stamford, Connecticut, United States
🇺🇸
Marin Cancer Care, Inc., Greenbrae, California, United States
🇺🇸
Covenant Health Care, Saginaw, Michigan, United States

and more 9 locations

Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)

Phase 1

Withdrawn

Conditions: Acute Myeloid Leukemia (AML)
Minimal Residual Disease

Interventions: Drug: Azacitidine
Drug: Avelumab

First Posted Date: 2018-10-09

Last Posted Date: 2019-02-20

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT03699384

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

Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers (AURA Trial)

Phase 2

Active, not recruiting

Conditions: Non-metastatic Muscle Invasive Bladder Cancer

Interventions: Drug: Avelumab
Procedure: cystectomy
Combination Product: DD-MVAC
Combination Product: CG
Combination Product: PG

First Posted Date: 2018-09-17

Last Posted Date: 2024-12-20

Lead Sponsor: Jules Bordet Institute

Target Recruit Count: 137

Registration Number: NCT03674424

Locations: 🇧🇪
Centre Hospitalier Universitaire et Psychiatrique de Mons-Borinage, Mons, Hainaut, Belgium
🇧🇪
UZAntwerpen, Edegem, Antwerpen, Belgium
🇧🇪
CHU de Liège Sart Tilman, Liège, Belgium

and more 7 locations

QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma.

Phase 1

Withdrawn

Conditions: Chordoma
Unresectable Malignant Neoplasm

Interventions: Biological: Aldoxorubicin Hydrochloride
Radiation: SBRT
Biological: ALT-803
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-6301
Biological: haNK
Drug: Avelumab
Drug: Cetuximab
Drug: Cyclophosphamide

First Posted Date: 2018-08-27

Last Posted Date: 2021-03-19

Lead Sponsor: ImmunityBio, Inc.

Registration Number: NCT03647423

Locations: 🇺🇸
Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States

A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

Phase 1

Terminated

Conditions: Pancreatic Cancer

Interventions: Drug: Avelumab
Drug: Talazoparib
Drug: Binimetinib

First Posted Date: 2018-08-20

Last Posted Date: 2022-01-26

Lead Sponsor: Pfizer

Target Recruit Count: 36

Registration Number: NCT03637491

Locations: 🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
University of Utah, Huntsman Cancer Hospital, Salt Lake City, Utah, United States
🇺🇸
University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States

and more 13 locations

RITUXIMAB + IMMUNOTHERAPY IN FOLLICULAR LYMPHOMA

Phase 1

Active, not recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Rituximab
Drug: Utomilumab
Drug: PF04518600
Drug: Avelumab

First Posted Date: 2018-08-17

Last Posted Date: 2022-03-18

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 24

Registration Number: NCT03636503

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Washington University in St. Louis, Saint Louis, Missouri, United States

and more 3 locations

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