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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
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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 : February 1, 2021
Estimated Study Completion Date : February 2, 2022

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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03391479


Contacts
Contact: Srikala Sridhar, M.D. 416-946-4501 ext 2662 srikala.sridhar@uhn.ca

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Srikala Sridhar, M.D.    416-946-4501 ext 2662    srikala.sridhar@uhn.ca   
Principal Investigator: Srikala Sridhar, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Srikala Sridhar, M.D. Princess Margaret Cancer Centre

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03391479     History of Changes
Other Study ID Numbers: WI222910
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Penile Diseases
Neoplasm Metastasis
Penile Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs