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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Vyriad, Inc.
Study ID
NCT04291105
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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. (CRC and melenoma cohorts are now closed to new patients)

Key Dates

First listed
Mar 2, 2020
Start date
Apr 24, 2020
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
87 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Melanoma intratumoral
    (CLOSED): 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.
  • Experimental: Head and Neck SCC intratumoral
    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.
  • Experimental: Colo-rectal Carcinoma intratumoral (Arm closed)
    (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.

Primary Outcome Measure

Objective response rate (ORR) per imaging assessment [ Time Frame: within 24 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Saint John's Health Center - John Wayne Cancer Institute (JWCI)Santa MonicaCalifornia90404-
Yale UniversityNew HavenConnecticut06520-8032-
University of MiamiMiamiFlorida33136-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Mayo ClinicRochesterMinnesota55905-
Billings Clinic Montana Cancer ConsortiumBillingsMontana59101-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of Cincinnati Medical CenterCincinnatiOhio45219-
Sanford Cancer CenterSioux FallsSouth Dakota57104-

Find similar trials in Santa Monica, CA

By condition
Head and neck cancerMelanoma
By specialty
OncologyENTSkin cancerDermatology
By research site
Saint John's Health Center - John Wayne Cancer Institute (JWCI)· Santa Monica, CAYale University· New Haven, CTUniversity of Miami· Miami, FLOchsner Clinic Foundation· New Orleans, LAMayo Clinic· Rochester, MNBillings Clinic Montana Cancer Consortium· Billings, MT

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