Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors
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.
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalVV1
VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit
- BiologicalCemiplimab
Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
Locations (27)
- Mayo ClinicalPhoenix, Arizona
- City of Hope Medical CenterDurate, California
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- HOAG Memorial Hospital PresbyterianNewport Beach, California
- Saint John's Health Center - John Wayne Cancer Institute (JWCI)Santa Monica, California
- Stanford Health CareStanford, California