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

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma; Colo-rectal Cancer; Melanoma
• Interventions: Biological: VV1; Biological: Cemiplimab

• 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.

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Study Start: 2020-04-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

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

Scroll for more (16 remaining)