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

NCT04291105 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

VV1

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

BIOLOGICAL

Cemiplimab

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

Sponsors & Collaborators

Principal Investigators

  • Alice Bexon, MD · CMO

  • Stephen J Russell, MD, Ph.D. · Clinical Lead

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291105 on ClinicalTrials.gov