Phase 2 Trial of Voyager V1 in Combination with Cemiplimab in Cancer Patients
- Conditions
- Head and Neck Squamous Cell CarcinomaColo-rectal CancerMelanoma
- Interventions
- Biological: VV1
- Registration Number
- NCT04291105
- Lead Sponsor
- Vyriad, Inc.
- Brief 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.
- Detailed Description
Patients enrolled into three parallel doublet cohorts with an optimal Simon's two stage design. Patients will receive Voyager V1 as a direct to tumor injection (IT) in all 3 cancer groups and cemiplimab via IV infusion. Patients will return for treatment every 3 weeks until lack of clinical benefit or limiting toxicity. Efficacy evaluations will be conducted every 6 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colo-rectal Carcinoma intratumoral (Arm closed) Cemiplimab (CLOSED) IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses. Melanoma intratumoral VV1 Melanoma, IT VV1 + IV cemiplimab Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses. Melanoma intratumoral Cemiplimab Melanoma, IT VV1 + IV cemiplimab Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses. Colo-rectal Carcinoma intratumoral (Arm closed) VV1 (CLOSED) IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses. Head and Neck SCC intratumoral VV1 HNSCC, IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses. Head and Neck SCC intratumoral Cemiplimab HNSCC, IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses.
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) per imaging assessment within 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
- Secondary Outcome Measures
Name Time Method Serum concentration time within 24 months Serum concentration time data using RT-PCR of VSV-IFNβ-NIS and systemic cemiplimab levels
To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ within 24 months To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ expression
Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0 within 24 months Safety and tolerability
Trial Locations
- Locations (26)
Mayo Clinical
🇺🇸Jacksonville, Florida, 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, District of Columbia, 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, RJ, Brazil
Hospital Moinhos de Vento
🇧🇷Porto Alegre, RS, Brazil
Hospital de Amor de Barretos
🇧🇷Barretos, SP, Brazil