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

Last updated: October 7, 2024
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

2

Condition

Metastatic Cancer

Genitourinary Cancer

Urologic Cancer

Treatment

Best Supportive Care

Avelumab

Clinical Study ID

NCT03391479
ALPACA
17-6013
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 ORdisease 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

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 drugspecifically 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 immunostimulatoryagent

  • Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressivetherapy

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Best Supportive Care
Phase: 2
Study Start date:
August 15, 2018
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.