Phase 2 Trial of Voyager V1 with Cemiplimab for Certain Cancers

This Phase 2 study is testing a combination of two treatments, VV1 and cemiplimab, for certain types of cancer that have continued to grow despite previous immunotherapy. The study aims to see how well this combination shrinks tumors and if it is safe. You might be able to join if you are at least 18 years old and have melanoma, head and neck squamous cell carcinoma (a type of head and neck cancer), or colorectal cancer. However, the colorectal cancer and melanoma groups are currently closed to new patients. The main goal is to measure how many patients experience their tumors shrinking (objective response rate) within 24 months. This study is currently not recruiting new patients for all groups.

Study design
This is a Phase 2 interventional study planning to enroll 87 participants across three cancer groups. It uses a specific design called Simon's two-stage design.
What's involved
You would receive VV1 as an injection directly into your tumor and cemiplimab through an IV. Treatments would occur every 3 weeks until the treatment is no longer beneficial or causes too many side effects, with efficacy checked every 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
The main measure of success (objective response rate) will be assessed within 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04291105

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Vyriad, Inc.
~87 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:VV1Cemiplimab

At a glance

Recruiting sites
0 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR) per imaging assessment
Measured over within 24 months
Melanoma
Head and Neck Squamous Cell Carcinoma
Colo-rectal Cancer
13 sites across 13 states
California1
Connecticut1
Florida1
Louisiana1
Minnesota1
Montana1
New York1
Ohio1
  • Alice Bexon, MD · STUDY_CHAIR · CMO
  • Stephen J Russell, MD, Ph.D. · STUDY_DIRECTOR · Clinical Lead

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Objective response rate (ORR) per imaging assessmentwithin 24 months

    Percentage of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through disease progression, by investigator review based on RECIST version 1.1