RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-04-24
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04291105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jennifer boughton
CONTACT
9085533135
Jboughton@vyriad.com

Principal Investigator

Alice Bexon, MD
STUDY_CHAIR
CMO
Stephen J Russell, MD, Ph.D.
STUDY_DIRECTOR
Clinical Lead

Study Locations (Sites)

Mayo Clinical
Phoenix, Arizona, 85054
United States
City of Hope Medical Center
Duarte, California, 91010
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
HOAG Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, 90404
United States
Stanford Health Care
Stanford, California, 94305
United States
Yale University
New Haven, Connecticut, 06520-8032
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
Mayo Clinical
Jacksonville, Florida, 32224
United States
University of Miami
Miami, Florida, 33136
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Billings Clinic Montana Cancer Consortium
Billings, Montana, 59101
United States
Atlantic Health
Morristown, New Jersey, 07960
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Ohio State University
Columbus, Ohio, 43210
United States
UPMC
Pittsburgh, Pennsylvania, 15213
United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
United States
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Vyriad, Inc.

  • Alice Bexon, MD, STUDY_CHAIR, CMO
  • Stephen J Russell, MD, Ph.D., STUDY_DIRECTOR, Clinical Lead

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-24
Study Completion Date2025-03

Study Record Updates

Study Start Date2020-04-24
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Solid Tumor

Additional Relevant MeSH Terms

  • Melanoma
  • Head and Neck Squamous Cell Carcinoma
  • Colo-rectal Cancer