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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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 • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Gastrointestinal disorders
6%
Investigations
6%
Infections and infestations
6%
Metabolism and nutrition disorders
6%
General disorders and administration site conditions
6%
Nervous system disorders
6%
Cardiac disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
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
1,476 Previous Clinical Trials
485,156 Total Patients Enrolled
Srikala Sridhar, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
127 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have signed up to be a part of this research project?

"That is accurate. The listing on clinicaltrials.gov does show that this research project, which was first advertised on August 15th 2018, has open positions for 24 participants at a single site."

Answered by AI

Are researchers looking for more participants in this trial?

"This trial, which was first posted on August 15th 2018 and last edited on November 26th 2021, is currently looking for participants, as reported on clinicaltrials.gov."

Answered by AI

What is the Avelumab FDA approval status?

"Avelumab is a medication that, while having some evidence of safety from Phase 2 clinical trials, has not been proven effective yet."

Answered by AI

To what extent has Avelumab been studied in other scientific investigations?

"Avelumab is currently being trialed in 116 studies, 10 of which are in the final stage before FDA approval. The trials have been conducted at 3691 locations worldwide, with a large focus in Barcelona and South dakota."

Answered by AI

Is this research project novel in terms of its design or implementation?

"Avelumab, a drug first trialed in 2014, has seen 116 clinical studies across 52 countries and 1024 cities. The first study, which completed its Phase 2 approval in 204 patients, was sponsored by EMD Serono Research & Development Institute, Inc. Since then, 70 more trials have been conducted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
2018. "A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03391479.
~1 spots leftby Jun 2024
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