Actively Recruiting
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
Led by Vyriad, Inc. · Updated on 2025-03-26
87
Participants Needed
27
Research Sites
292 weeks
Total Duration
On this page
Sponsors
V
Vyriad, Inc.
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on the day of signing informed consent
- For head and neck cancer: confirmed advanced/metastatic squamous cell carcinoma suitable for first-line immunotherapy, including HPV+ and HPV- patients with primary tumors in oropharynx, oral cavity, hypopharynx, or larynx, PD-L1 status ≥ 1%, no prior anti-PD-(L)1 treatment, and at least 12 months since last full-dose systemic chemotherapy
- For melanoma: confirmed advanced/metastatic cutaneous melanoma with no beneficial existing options, prior anti-PD-(L)1 therapy lasting ≥ 12 weeks, radiological progression during/after PD-(L)1 therapy, and prior BRAF inhibitor treatment if BRAF V600-positive
- For colorectal cancer: confirmed advanced/metastatic CRC, received or ineligible for standard therapies including fluoropyrimidine(s), oxaliplatin, irinotecan, anti-VEGF and EGFR-targeted therapies, non-MSI high, and progression on previous systemic therapy
- At least one tumor lesion suitable for injection and biopsy, not previously irradiated
- Measurable disease based on RECIST 1.1 with at least one measurable lesion for injection
- ECOG performance status 0 or 1
- Life expectancy greater than 3 months
- Willing to provide required biological samples, including fresh tumor biopsy during the study
- Adequate organ function confirmed by labs within 14 days before enrollment
You will not qualify if you...
- Availability of and acceptance for an alternative curative treatment
- Tumor lesions larger than 5 cm in diameter
- Active serious infections of Grade 3 or higher within 2 weeks before registration
- Diagnosis of ocular, mucosal, or acral melanoma
- Known HIV infection with active infection
- Active viral infection with HBV or HCV
- History of active or latent tuberculosis
- Serious health conditions posing undue risk, such as uncontrolled hypertension, diabetes, significant pulmonary or neurological disorders
- Recent prior therapies: investigational agents within 2 weeks, chemotherapy or antibodies within 3 weeks, radioimmunoconjugates within 6 weeks
- Severe heart conditions such as NYHA class III/IV, symptomatic coronary artery disease, or arrhythmias
- Active organ-threatening autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- Immunodeficiency or immunosuppression including corticosteroids over 10 mg/day prednisone equivalent within 1 week prior to treatment
- History of severe immune-mediated adverse reactions to immune checkpoint inhibitors
- Unresolved toxicities from previous therapies worse than Grade 1
- History or current pneumonitis requiring steroids
- High volume disease assessed clinically
- Portal vein thrombosis beyond intrahepatic branches
- Known concurrent malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Mayo Clinical
Phoenix, Arizona, United States, 85054
Withdrawn
2
City of Hope Medical Center
Durate, California, United States, 91010
Withdrawn
3
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Withdrawn
4
HOAG Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Withdrawn
5
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, United States, 90404
Terminated
6
Stanford Health Care
Stanford, California, United States, 94305
Withdrawn
7
Yale University
New Haven, Connecticut, United States, 06520-8032
Actively Recruiting
8
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Withdrawn
9
Mayo Clinical
Jacksonville, Florida, United States, 32224
Withdrawn
10
University of Miami
Miami, Florida, United States, 33136
Completed
11
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
12
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Withdrawn
13
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Withdrawn
14
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Billings Clinic Montana Cancer Consortium
Billings, Montana, United States, 59101
Terminated
16
Atlantic Health
Morristown, New Jersey, United States, 07960
Withdrawn
17
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Withdrawn
18
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
19
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
20
Ohio State University
Columbus, Ohio, United States, 43210
Withdrawn
21
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Withdrawn
22
Sanford Cancer Center
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
23
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, United States, 78229
Withdrawn
24
Hospital Sao Rafael
Salvador, BR, Brazil, 41253-190
Actively Recruiting
25
INCA
Rio de Janeiro, Rio de Janeiro, Brazil, 20231-050
Actively Recruiting
26
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
Actively Recruiting
27
Hospital de Amor de Barretos
Barretos, São Paulo, Brazil, 14.784-400
Active, Not Recruiting
Research Team
J
Jennifer boughton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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