Using avelumab for treating advanced penile cancer in patients unfit for chemotherapy
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
PHASE2 · University Health Network, Toronto · NCT03391479
This study is testing if avelumab can help shrink tumors in patients with advanced penile cancer who can't have chemotherapy or haven't responded to it.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto (other) |
| Drugs / interventions | ipilimumab, chemotherapy, immunotherapy, radiation, avelumab |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03391479 on ClinicalTrials.gov |
What this trial studies
This phase 2 study evaluates the effectiveness of avelumab, an investigational monoclonal antibody, in patients with locally advanced or metastatic penile cancer who are either unfit for or have progressed after platinum-based chemotherapy. The study aims to assess the anti-tumor activity of avelumab by measuring the objective response rate in this specific patient population. Avelumab works by blocking the interaction between PD-L1 and PD-1, which may help to stop or shrink tumors. Participants will also receive best supportive care during the study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed squamous cell carcinoma of the penis that is unresectable or metastatic.
Not a fit: Patients who have previously received certain immunotherapies or have active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced penile cancer who have limited treatment choices.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in various cancers, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Srikala Sridhar, M.D. — Princess Margaret Cancer Centre
- Study coordinator: Srikala Sridhar, M.D.
- Email: srikala.sridhar@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Penile Cancer, Advanced Cancer, Metastatic Cancer