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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT03391479

Collaborator

(none)

Enrollment

Location

Arm

58.5

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Penile Cancer Advanced Cancer Metastatic Cancer	Drug: Avelumab Other: Best Supportive Care	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 15, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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). Other: Best Supportive Care As required.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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).

Other: Best Supportive Care

As required.

Outcome Measures

Primary Outcome Measures

Objective Response Rate [4 weeks]
To demonstrate the anti-tumor activity of avelumab by objective response rate (ORR) according to Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in patients with locally advanced or metastatic penile carcinoma unfit for platinum-based chemotherapy or progressed on or after platinum-based chemotherapy.

Secondary Outcome Measures

Progression-free Survival Rate [3 years]
Assess the progression free survival (PFS) of avelumab in patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of <1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients
Overall Survival Rate [3 years]
Assess the overall survival (OS) of avelumab in patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of <1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Srikala Sridhar, M.D., Princess Margaret Cancer Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03391479

Other Study ID Numbers:

ALPACA
17-6013

First Posted:

Jan 5, 2018

Last Update Posted:

Dec 9, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Penile Neoplasms

Avelumab

Study Results

No Results Posted as of Dec 9, 2021