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

Metastatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391479
• Other study ID #: ALPACA
• Secondary ID: 17-6013
• Status: Recruiting
• Phase: Phase 2
• Start date: August 15, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: Srikala Sridhar, M.D.
• Phone: 416-946-4501
• Email: srikala.sridhar[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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-a, 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

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Penile Cancer
• Penile Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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	3 years
Secondary	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	3 years