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Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors

NCT04291105•Vyriad, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inclusion:
•1. Age ≥18 years on day of signing informed consent.
•2. 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.
+5 more criteria

Exclusion Criteria

•ii. Non-microsatellite instability high (non-MSI high).
•iii. Progression on previous systemic therapy.
•3. At least one tumor lesion amenable to IT injection and biopsy that has not been previously irradiated.
•4. Measurable disease based on RECIST 1.1., including ≥ 1 measurable lesion(s) to be injected
•5. Performance status of 0 or 1 on the ECOG Performance Scale
•6. Life expectancy of \>3 months.
•7. Willingness to provide biological samples required for the duration of the study, including a fresh tumor biopsy sample whilst on study.
•8. Adequate organ function assessed by laboratory values obtained ≤14 days prior to enrollment
•Exclusion:
•1. Availability of and patient acceptance of an alternative curative therapeutic option.
+21 more criteria

Locations (27)

Mayo Clinical

Phoenix, Arizona, 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 D.C., District of Columbia, United States

Mayo Clinical

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Key Dates

Start Date

April 24, 2020

Primary Completion Date

June 1, 2025

Completion Date

December 1, 2025

Last Updated

March 26, 2025

Enrollment

ESTIMATED participants

Conditions

MelanomaHead and Neck Squamous Cell CarcinomaColo-rectal Cancer

Interventions

VV1

BIOLOGICAL

Cemiplimab

BIOLOGICAL

Contacts

Jennifer boughton

CONTACT

9085533135 Jboughton@vyriad.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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