A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03391479|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : September 20, 2018
This is a phase 2 study whose purpose is see how useful investigational drug, avelumab, is in patients with locally advanced or metastatic penile cancer who are unfit for or progressed on platinum-based chemotherapy.
The usefulness of avelumab in this study population will be determined by anti-tumor activity assessed by objective response rate.
Avelumab is a monoclonal antibody that binds to a protein called programmed death-ligand 1 (PD-L1) and blocks its communication with another protein called programmed death protein 1 (PD-1). The communication of these proteins are thought to be important in the growth of tumors. Blocking these proteins from communicating may stop or shrink tumors.
|Condition or disease||Intervention/treatment||Phase|
|Penile Cancer Advanced Cancer Metastatic Cancer||Drug: Avelumab Other: Best Supportive Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed On or After Platinum-based Chemotherapy|
|Actual Study Start Date :||August 15, 2018|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 2, 2022|
Experimental: Avelumab and Best Supportive Care
Avelumab will be given intravenously (by vein) at a dose of 10 mg/kg, once every 2 weeks
Best supportive care will be provided as required.
Avelumab is a fully human monoclonal antibody (mAb) of the immunoglobulin (Ig) G1 isotype. Avelumab selectively binds to programmed death-ligand 1 (PD-L1) and competitively blocks its interaction with programmed death protein 1 (PD-1).
Other: Best Supportive Care
- Objective Response Rate [ Time Frame: 4 weeks ]
- Progression-free Survival Rate [ Time Frame: 3 years ]
- Overall Survival Rate [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391479
|Contact: Srikala Sridhar, M.D.||416-946-4501 ext firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Srikala Sridhar, M.D. 416-946-4501 ext 2662 email@example.com|
|Principal Investigator: Srikala Sridhar, M.D.|
|Principal Investigator:||Srikala Sridhar, M.D.||Princess Margaret Cancer Centre|