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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

Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)

Phase 1
Terminated
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2015-10-22
Last Posted Date
2023-07-07
Lead Sponsor
Pfizer
Target Recruit Count
43
Registration Number
NCT02584634
Locations
🇺🇸

Ophthalmic Consultants of Boston Inc (OCB), Boston, Massachusetts, United States

🇯🇵

Aichi cancer center central hospital, Nagoya, Aichi, Japan

🇪🇸

Hospital Universitari de la Vall d'Hebron, Barcelona, Spain

and more 17 locations

Avelumab in First-line NSCLC (JAVELIN Lung 100)

First Posted Date
2015-10-15
Last Posted Date
2025-01-31
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
1214
Registration Number
NCT02576574
Locations
🇧🇪

A.Z. Klina, Brasschaat, Belgium

🇦🇺

Fiona Stanley Hospital, Murdoch, Western Australia, Australia

🇺🇸

Arizona Center for Cancer Care, Surprise, Arizona, United States

and more 344 locations

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)

Phase 1
Terminated
Conditions
Advanced Cancer
Interventions
First Posted Date
2015-09-18
Last Posted Date
2024-07-30
Lead Sponsor
Pfizer
Target Recruit Count
409
Registration Number
NCT02554812
Locations
🇺🇸

Florida Cancer Specialists, Sarasota, Florida, United States

🇦🇺

The Mater Hospital, North Sydney, New South Wales, Australia

🇺🇸

Mount Sinai Comprehensive Cancer Center - Aventura, Aventura, Florida, United States

and more 80 locations

A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)

Phase 1
Completed
Conditions
Renal Cell Cancer
Interventions
First Posted Date
2015-07-09
Last Posted Date
2022-02-18
Lead Sponsor
Pfizer
Target Recruit Count
55
Registration Number
NCT02493751
Locations
🇯🇵

Kindai University Hospital, Osakasayama, Osaka, Japan

🇯🇵

Keio University Hospital, Shinjuku-ku, Tokyo, Japan

🇺🇸

Scottsdale Healthcare Hospitals d/b/a HonorHealth, Scottsdale, Arizona, United States

and more 17 locations

Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

Phase 3
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2015-03-20
Last Posted Date
2020-08-03
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
792
Registration Number
NCT02395172
Locations
🇨🇴

Hemato Oncologos S.A., Cali, Colombia

🇺🇸

Healing Hands Oncology and Medical Care, Lawndale, California, United States

🇦🇷

Hospital Universitario Austral, Pilar, Argentina

and more 256 locations

Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)

Phase 1
Terminated
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2015-01-29
Last Posted Date
2021-06-10
Lead Sponsor
Pfizer
Target Recruit Count
65
Registration Number
NCT02349633
Locations
🇺🇸

UPMC Cancer Pavilion, Pittsburgh, Pennsylvania, United States

🇺🇸

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

🇦🇺

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

and more 12 locations

Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)

Phase 2
Completed
Conditions
Carcinoma, Merkel Cell
Interventions
First Posted Date
2014-06-04
Last Posted Date
2024-03-13
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
204
Registration Number
NCT02155647
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

🇮🇹

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

🇮🇹

Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy

and more 58 locations

Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor JPN)

Phase 1
Completed
Conditions
Solid Tumors
Interventions
First Posted Date
2013-09-17
Last Posted Date
2020-09-30
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
57
Registration Number
NCT01943461
Locations
🇩🇪

Research site, Darmstadt, Germany

Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)

Phase 1
Completed
Conditions
Solid Tumors
Interventions
First Posted Date
2013-01-21
Last Posted Date
2021-12-20
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
1756
Registration Number
NCT01772004
Locations
🇺🇸

Cancer Treatment Centers of America - Western Regional Medical Center, Goodyear, Arizona, United States

🇺🇸

Highlands Oncology Group, Rogers, Arkansas, United States

🇺🇸

California Cancer Associates for Research & Excellence, Inc, Encinitas, California, United States

and more 71 locations
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