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

NPC - AXEL Study : Axitinib-Avelumab

Phase 2

Completed

Conditions: Recurrent or Metastatic NPC

Interventions: Drug: Axitinib
Drug: Avelumab

First Posted Date: 2020-09-24

Last Posted Date: 2025-01-10

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 13

Registration Number: NCT04562441

Locations: 🇭🇰
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong

Avelumab Plus Cetuximab in Pre-treated RAS Wild Type Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer
RAS Wild Type

Interventions: Drug: Avelumab
Drug: Cetuximab

First Posted Date: 2020-09-23

Last Posted Date: 2022-05-05

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Target Recruit Count: 77

Registration Number: NCT04561336

Locations: 🇮🇹
Università della Campania Luigi Vanvitelli, Napoli, Italy

Axitinib Therapy Management Study

Withdrawn

Conditions: Renal Cell Carcinoma

First Posted Date: 2020-09-18

Last Posted Date: 2023-11-21

Lead Sponsor: Pfizer

Registration Number: NCT04555603

Locations: 🇺🇸
Pfizer Inc., New York, New York, United States

FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumor, Adult

Interventions: Drug: FT516
Drug: Avelumab
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: IL-2

First Posted Date: 2020-09-16

Last Posted Date: 2023-09-21

Lead Sponsor: Fate Therapeutics

Target Recruit Count: 12

Registration Number: NCT04551885

Locations: 🇺🇸
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Hackensack University Medical Center/John Theurer Cancer Center, Hackensack, New Jersey, United States

AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: 5Fluorouracil
Drug: L-leucovorin
Drug: Irinotecan
Drug: Oxaliplatin
Drug: Cetuximab
Drug: Avelumab

First Posted Date: 2020-08-14

Last Posted Date: 2025-01-09

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 62

Registration Number: NCT04513951

Locations: 🇮🇹
U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa, Pisa, Italy

Immune Checkpoint Inhibitor In High Risk Oral Premalignant Lesions

Phase 2

Conditions: Oral Premalignant Lesions

Interventions: Drug: Avelumab

First Posted Date: 2020-08-07

Last Posted Date: 2020-12-01

Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Target Recruit Count: 240

Registration Number: NCT04504552

Locations: 🇮🇹
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS, Candiolo, Torino, Italy
🇮🇹
ASST Spedali Civili di Brescia, Brescia, Italy
🇮🇹
Istituto nazionale dei tumori Regina Elena, Roma, Italy

and more 2 locations

Avelumab and Methotrexate in in Low-risk Gestational Trophoblastic Neoplasias as First Line Treatment

Phase 1

Recruiting

Conditions: Gestational Trophoblastic Neoplasias (GTN)

Interventions: Drug: Avelumab Injection
Drug: Methotrexate 1 GM Injection

First Posted Date: 2020-05-20

Last Posted Date: 2024-02-29

Lead Sponsor: Hospices Civils de Lyon

Target Recruit Count: 26

Registration Number: NCT04396223

Locations: 🇫🇷
Centre François Baclesse, Caen, France
🇫🇷
Centre Hospitalier Lyon Sud, Pierre-Bénite, Pierre Bénite, France
🇫🇷
Institut Bergonié, Bordeaux, France

and more 6 locations

Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy

Phase 1

Active, not recruiting

Conditions: Advanced Malignant Skin Neoplasm
Metastatic Malignant Skin Neoplasm

Interventions: Drug: Atezolizumab
Drug: Avelumab
Biological: Cemiplimab
Biological: Durvalumab
Biological: Nivolumab
Biological: Pembrolizumab
Other: Quality-of-Life Assessment
Other: Short-Term Fasting

First Posted Date: 2020-05-13

Last Posted Date: 2024-10-10

Lead Sponsor: University of Southern California

Target Recruit Count: 10

Registration Number: NCT04387084

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

Phase 1

Recruiting

Conditions: Triple Negative Breast Cancer
Locally Advanced Breast Cancer
Recurrent Breast Cancer
Metastatic Breast Cancer
ER+ Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: Palbociclib
Drug: Avelumab

First Posted Date: 2020-04-24

Last Posted Date: 2024-12-27

Lead Sponsor: Royal Marsden NHS Foundation Trust

Target Recruit Count: 45

Registration Number: NCT04360941

Locations: 🇬🇧
University College London Hospitals NHS Foundation Trust, London, United Kingdom
🇬🇧
The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
🇬🇧
Addenbrooke's Hospital Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

and more 5 locations

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

Phase 2

Recruiting

Conditions: Cancer
Tumors
Neoplasms
Neoplasia

Interventions: Drug: Vemurafenib plus Cobimetinib (combination)
Drug: Trastuzumab plus Pertuzumab (combination)
Drug: Alectinib
Drug: Axitinib
Drug: Erlotinib
Drug: Atezolizumab
Drug: Avelumab
Drug: Trastuzumab emtansine
Drug: Vismodegib
Drug: Niraparib

First Posted Date: 2020-04-10

Last Posted Date: 2022-10-26

Lead Sponsor: Ulrik Lassen

Target Recruit Count: 300

Registration Number: NCT04341181

Locations: 🇩🇰
Aarhus University Hospital, Aarhus, Denmark
🇩🇰
Rigshospitalet, Copenhagen, Denmark
🇩🇰
Odense University Hospital, Odense, Denmark

and more 4 locations

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