RecruitingPhase 2NCT04291105

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors

Sponsor

Vyriad, Inc.

Enrollment

87 participants

Start Date

Apr 24, 2020

Study Type

INTERVENTIONAL

Conditions

Melanoma Head and Neck Squamous Cell Carcinoma Colo-rectal Cancer

Summary

This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This phase 2 trial tests a new treatment called Voyager V1 combined with the immunotherapy drug cemiplimab in patients with advanced cancers — particularly head and neck cancers or cervical cancer. The study is looking for better first-line treatment options for patients who are eligible for immunotherapy. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic head and neck squamous cell cancer (including HPV-positive or HPV-negative) suitable for first-line immunotherapy, OR - You have advanced cervical cancer eligible for immunotherapy - Your tumor has a PD-L1 score of 1% or higher **You may NOT be eligible if...** - Your cancer is in the nasopharynx or salivary glands (for head and neck cohort) - You have already received systemic therapy for advanced disease - Your PD-L1 score does not meet the threshold Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVV1

VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit

BIOLOGICALCemiplimab

Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.

Locations(27)

Mayo Clinical

Phoenix, Arizona, United States

City of Hope Medical Center

Durate, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

HOAG Memorial Hospital Presbyterian

Newport Beach, California, United States

Saint John's Health Center - John Wayne Cancer Institute (JWCI)

Santa Monica, California, United States

Stanford Health Care

Stanford, California, United States

Yale University

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Mayo Clinical

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Billings Clinic Montana Cancer Consortium

Billings, Montana, United States

Atlantic Health

Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

UPMC

Pittsburgh, Pennsylvania, United States

Sanford Cancer Center

Sioux Falls, South Dakota, United States

UT Health San Antonio MD Anderson Cancer Center

San Antonio, Texas, United States

Hospital Sao Rafael

Salvador, BR, Brazil

INCA

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Amor de Barretos

Barretos, São Paulo, Brazil

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04291105

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