NCT04291105

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Vyriad, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Head and Neck Squamous Cell Carcinoma
• Colo-rectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	VV1	VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit
BIOLOGICAL	Cemiplimab	Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.

Timeline

• Start date: 2020-04-24
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2020-03-02
• Last updated: 2025-03-26

Locations

27 sites across 2 countries: United States, Brazil

Regulatory

• FDA-regulated drug study