Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
1 other identifier
interventional
87
2 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2020
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedStudy Start
First participant enrolled
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 26, 2025
March 1, 2025
5.1 years
February 25, 2020
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR) per imaging assessment
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
within 24 months
Secondary Outcomes (3)
Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0
within 24 months
Serum concentration time
within 24 months
To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ
within 24 months
Study Arms (3)
Melanoma intratumoral
EXPERIMENTALMelanoma, 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
EXPERIMENTALHNSCC, 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)
EXPERIMENTAL(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.
Interventions
VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit
Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
Eligibility Criteria
You may qualify if:
- Age ≥18 years on day of signing informed consent.
- Specific by tumor cohorts:
- a. For the HSNCC cohort, histologically confirmed diagnosis of advanced and/or metastatic HSNCC suitable for first line immunotherapy.
- i. HPV+ and HPV- patients are allowed.
- ii. Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology) or salivary gland tumors.
- iii. PD-L1 status ≥ 1% per local CPS score. Samples should be provided to central lab for post-hoc centralized testing.
- iv. At least 12 months between last dose of prior adjuvant therapy and date of relapse diagnosis (if given). For the purposes of this protocol, "prior adjuvant therapy" only applies to full dose systemic chemotherapy (such as pre-operative systemic induction chemotherapy), but does not include radiation + surgery, or radiation + low or partial dose platinum radiosensitization. There is no time limit (washout) between the end of any prior radiation/ chemoradiation and the start of study drug v. No prior anti-PD-(L)1 treatment for HNSCC.
- b. For the melanoma cohorts, histologically confirmed diagnosis of advanced and/or metastatic cutaneous melanoma for which no existing options are considered to provide clinical benefit.
- i. Best response of uPR, SD or PD to an anti-PD-(L)1-containing regimen.
- ii. Prior anti-PD-(L)1 therapy must have lasted ≥ 12 weeks.
- iii. Radiological progression was demonstrated during or after therapy with a PD-(L)1 immune CPI (only one prior line of PD-(L)1 therapy is permitted.
- iv. If patient received anti-PD-1 as prior adjuvant therapy, patient should have relapsed during therapy or within the subsequent 6 months after last dose. Note: Progression on ipilimumab is not required.
- v. Patients with BRAF V600-positive tumor(s) should have received prior treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor) in addition to treatment with an anti-PD-1 or to have declined targeted therapy. Note: Patients with BRAF V600-positive tumors with no clinically significant tumor-related symptoms nor evidence of rapidly progressive disease are not required to be treated with a BRAF inhibitor (alone or in combination with a MEK inhibitor) based on investigator's decision
- c. For the CRC cohort, a histologically confirmed diagnosis of advanced and/or metastatic CRC.
- i. Received or are not eligible for standard of care fluoropyrimidine(s), oxaliplatin, irinotecan, anti-VEGF and EGFR-targeted therapies.
- +8 more criteria
You may not qualify if:
- Availability of and patient acceptance of an alternative curative therapeutic option.
- Patients with tumor lesion(s) \> 5cm in diameter.
- Recent or ongoing serious infection, including any active Grade 3 or higher per the NCI CTCAE, v5.0 viral, bacterial, or fungal infection within 2 weeks of registration.
- Patients who have a diagnosis of ocular, mucosal or acral melanoma.
- Known seropositivity for and with active infection with HIV.
- Seropositive for and with evidence of active viral infection with HBV.
- Seropositive for and with active viral infection with HCV.
- Known history of active or latent TB.
- Any concomitant serious health condition, which, in the opinion of the investigator, would place the patient at undue risk from the study, including uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
- Prior therapy within the following timeframe before the planned start of study treatment as follows:
- Small molecule inhibitors, and/or other investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
- Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.
- Radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.
- NYHA classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or SVT).
- Any known or suspected active organ-threatening autoimmune disease, such as inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis, with the exception of hypothyroidism and type 1 diabetes that are controlled with treatment
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vyriad, Inc.lead
- Regeneron Pharmaceuticalscollaborator
Study Sites (27)
Mayo Clinical
Phoenix, Arizona, 85054, United States
City of Hope Medical Center
Durate, 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 D.C., 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
Hospital Sao Rafael
Salvador, BR, 41253-190, Brazil
INCA
Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000, Brazil
Hospital de Amor de Barretos
Barretos, São Paulo, 14.784-400, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alice Bexon, MD
CMO
- STUDY DIRECTOR
Stephen J Russell, MD, Ph.D.
Clinical Lead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2020
First Posted
March 2, 2020
Study Start
April 24, 2020
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
March 26, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share