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

Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma

Phase 2

Terminated

Conditions: Adenocarcinoma

Interventions: Drug: Avelumab

First Posted Date: 2016-12-21

Last Posted Date: 2022-04-14

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 8

Registration Number: NCT03000179

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH)

Phase 3

Active, not recruiting

Conditions: HNSCC

Interventions: Drug: Cisplatin
Drug: Cetuximab
Radiation: IMRT
Drug: avelumab

First Posted Date: 2016-12-21

Last Posted Date: 2024-07-10

Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

Target Recruit Count: 707

Registration Number: NCT02999087

Locations: 🇫🇷
Centre Hospitalier Bretagne Sud, Lorient, France

A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)

Phase 1

Terminated

Conditions: Advanced Solid Tumors

Interventions: Drug: Avelumab (Once weekly)
Drug: Avelumab
Drug: M9241
Drug: Avelumab (Expansion cohort)
Drug: M9241 (MTD)

First Posted Date: 2016-12-16

Last Posted Date: 2020-12-17

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

Target Recruit Count: 52

Registration Number: NCT02994953

Locations: 🇺🇸
St Joseph Heritage Healthcare, Santa Rosa, California, United States
🇺🇸
Metairie Oncologists, LLC, Metairie, Louisiana, United States
🇮🇹
IOV - Istituto Oncologico Veneto IRCCS, Padova, Italy

and more 30 locations

Avelumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Recurrent Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia

Interventions: Drug: Avelumab
Drug: Azacitidine
Other: Laboratory Biomarker Analysis

First Posted Date: 2016-11-02

Last Posted Date: 2020-10-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 19

Registration Number: NCT02953561

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

Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)

Phase 3

Terminated

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Other: Chemoradiation
Drug: Avelumab

First Posted Date: 2016-11-02

Last Posted Date: 2021-09-22

Lead Sponsor: Pfizer

Target Recruit Count: 697

Registration Number: NCT02952586

Locations: 🇺🇸
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center, Bakersfield, California, United States
🇺🇸
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc., Riverside, California, United States
🇺🇸
University of Maryland, Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 285 locations

Bioimmunoradiotherapy (Cetuximab/RT/Avelumab)

Phase 1

Completed

Conditions: Carcinoma, Squamous Cell of Head and Neck

Interventions: Drug: avelumab
Radiation: radiotherapy
Drug: cetuximab

First Posted Date: 2016-10-19

Last Posted Date: 2019-12-11

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 10

Registration Number: NCT02938273

Locations: 🇳🇱
Antoni van Leeuwenhoek, Amsterdam, Netherlands

Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer

Phase 1

Completed

Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer

Interventions: Drug: entinostat
Drug: avelumab
Drug: Placebo

First Posted Date: 2016-09-27

Last Posted Date: 2024-01-10

Lead Sponsor: Syndax Pharmaceuticals

Target Recruit Count: 140

Registration Number: NCT02915523

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research, Tampa, Florida, United States
🇺🇸
HCA Midwest Health (SCRI Affiliate), Kansas City, Missouri, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

and more 9 locations

Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Endometrial Cancer

Interventions: Drug: Avelumab
Drug: Talazoparib
Drug: Axitinib

First Posted Date: 2016-09-23

Last Posted Date: 2024-07-05

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 106

Registration Number: NCT02912572

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer

Phase 2

Terminated

Conditions: Nasopharyngeal Cancer

Interventions: Drug: Avelumab

First Posted Date: 2016-08-23

Last Posted Date: 2024-08-28

Lead Sponsor: Assuntina Sacco, M.D.

Target Recruit Count: 6

Registration Number: NCT02875613

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States

Avelumab for People With Recurrent Respiratory Papillomatosis

Phase 2

Completed

Conditions: Recurrent Respiratory Papillomatosis
Juvenile Laryngeal Papilloma
Respiratory Papillomatosis
Laryngeal Papilloma, Recurrent
Human Papilloma Virus

Interventions: Drug: Avelumab

First Posted Date: 2016-08-09

Last Posted Date: 2021-11-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 13

Registration Number: NCT02859454

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Drug Development Updates

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