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A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03391479
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : June 29, 2021
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arm Intervention/treatment
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.

Drug: Avelumab
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
As required.

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Progression-free Survival Rate [ Time Frame: 3 years ]
  2. Overall Survival Rate [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the penis
  • Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
  • Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy
  • ≥18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

  • Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment
  • Known symptomatic central nervous system (CNS) metastases requiring steroids
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy

Information from the National Library of Medicine

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 identifier (NCT number): NCT03391479

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Contact: Srikala Sridhar, M.D. 416-946-4501 ext 2662

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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Srikala Sridhar, M.D.    416-946-4501 ext 2662   
Principal Investigator: Srikala Sridhar, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Srikala Sridhar, M.D. Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto Identifier: NCT03391479    
Other Study ID Numbers: 17-6013
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Penile Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Penile Diseases