Back to resultsA Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
Primary Purpose
Penile Cancer, Advanced Cancer, Metastatic Cancer
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Avelumab
Best Supportive Care
Sponsored by
About this trial
This is an interventional treatment trial for Penile Cancer
Eligibility 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
Sites / Locations
- Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Avelumab and Best Supportive Care
Arm Description
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.
Outcomes
Primary Outcome Measures
Objective Response Rate
To demonstrate the anti-tumor activity of avelumab by objective response rate (ORR) according to Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in patients with locally advanced or metastatic penile carcinoma unfit for platinum-based chemotherapy or progressed on or after platinum-based chemotherapy.
Secondary Outcome Measures
Progression-free Survival Rate
Assess the progression free survival (PFS) of avelumab in patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of <1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients
Overall Survival Rate
Assess the overall survival (OS) of avelumab in patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of <1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients
Full Information
NCT ID
NCT03391479
First Posted
December 29, 2017
Last Updated
June 15, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03391479
Brief Title
A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Cancer, Advanced Cancer, Metastatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Avelumab and Best Supportive Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Avelumab
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Best Supportive Care
Intervention Description
As required.
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
To demonstrate the anti-tumor activity of avelumab by objective response rate (ORR) according to Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in patients with locally advanced or metastatic penile carcinoma unfit for platinum-based chemotherapy or progressed on or after platinum-based chemotherapy.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Progression-free Survival Rate
Description
Assess the progression free survival (PFS) of avelumab in patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of <1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients
Time Frame
3 years
Title
Overall Survival Rate
Description
Assess the overall survival (OS) of avelumab in patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of <1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients
Time Frame
3 years
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Srikala Sridhar, M.D.
Phone
416-946-4501
Ext
2662
Email
srikala.sridhar@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srikala Sridhar, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srikala Sridhar, M.D.
Phone
416-946-4501
Ext
2662
Email
srikala.sridhar@uhn.ca
First Name & Middle Initial & Last Name & Degree
Srikala Sridhar, M.D.
12. IPD Sharing Statement
Learn more about this trial
A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
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