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Monoclonal Antibodies
Avelumab for Penile Cancer
Phase 2
Recruiting
Led By Srikala Sridhar, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy
Histologically confirmed squamous cell carcinoma of the penis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will test the hypothesis that avelumab is an effective treatment for patients with locally advanced or metastatic penile cancer who are unfit for or progressed on platinum-based chemotherapy.
Who is the study for?
This trial is for adults over 18 with advanced penile cancer that can't be treated with surgery or has worsened after platinum-based chemotherapy. Participants should have a performance status indicating they are fully active or at most, require some assistance.Check my eligibility
What is being tested?
The study tests Avelumab's effectiveness against penile cancer by observing tumor response rates. Avelumab is an antibody drug designed to block proteins (PD-L1 and PD-1) that may help tumors grow, potentially stopping or shrinking them.See study design
What are the potential side effects?
Avelumab might cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, and possibly exacerbate autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be removed by surgery and does not respond to or is unfit for platinum-based chemotherapy.
Select...
My cancer is a type of skin cancer called squamous cell carcinoma, located on the penis.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Overall Survival Rate
Progression-free Survival Rate
Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Cardiac disorders
6%
Endocrine disorders
6%
Investigations
6%
Metabolism and nutrition disorders
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Nervous system disorders
6%
Infections and infestations
6%
Respiratory, thoracic and mediastinal disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Avelumab and Best Supportive CareExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,393 Total Patients Enrolled
Srikala Sridhar, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
127 Total Patients Enrolled
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