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

NCT ID: NCT03391479

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Penile Cancer Advanced Cancer Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avelumab and Best Supportive Care

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.

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

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).

Best Supportive Care

Intervention Type OTHER

As required.

Interventions

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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).

Intervention Type DRUG

Best Supportive Care

As required.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Srikala Sridhar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ALPACA

Identifier Type: -

Identifier Source: org_study_id

17-6013

Identifier Type: OTHER

Identifier Source: secondary_id