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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Vyriad, Inc.
Study ID
NCT04291105
Phase
PHASE2
Status
Recruiting
Apply to this trial

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.

Key Dates

Start date
Apr 24, 2020
Status verified
Mar 2025
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Melanoma intratumoral
    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 ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Mayo ClinicalPhoenixArizona85054-
City of Hope Medical CenterDurateCalifornia91010-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
HOAG Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Saint John's Health Center - John Wayne Cancer Institute (JWCI)Santa MonicaCalifornia90404-
Stanford Health CareStanfordCalifornia94305-
Yale UniversityNew HavenConnecticut06520-8032
Neta Shanwetter Levit, MPH
[email protected]
203.500.0834
Barbara Johnson
[email protected]
Mario Sznol, MD (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Mayo ClinicalJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
Ochsner Clinic FoundationNew OrleansLouisiana70121
Amanda Woolery, RN, BSN
[email protected]
504-842-0275.
Daniel Johnson, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55905
Clinical Trials Referal Office
855-776-0015
Patrick McGarrah, MD (PRINCIPAL_INVESTIGATOR)
Billings Clinic Montana Cancer ConsortiumBillingsMontana59101-
Atlantic HealthMorristownNew Jersey07960-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Ashley Poliak Hammad, MSN
[email protected]
212-824-7309
Thomas Marron, MD (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Medical CenterCincinnatiOhio45219
Trisha Wise-Draper, MD, PhD
[email protected]
513-584-7698
Ohio State UniversityColumbusOhio43210-
UPMCPittsburghPennsylvania15213-
Sanford Cancer CenterSioux FallsSouth Dakota57104
Staci Vogel
[email protected]
605-312-3320
Steven Powell, MD (PRINCIPAL_INVESTIGATOR)
UT Health San Antonio MD Anderson Cancer CenterSan AntonioTexas78229-

Find similar trials in Phoenix, AZ

By condition
Head and neck cancerMelanoma
By specialty
OncologyENTSkin cancerDermatology
By research site
Mayo Clinical· Phoenix, AZCity of Hope Medical Center· Durate, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAHOAG Memorial Hospital Presbyterian· Newport Beach, CASaint John's Health Center - John Wayne Cancer Institute (JWCI)· Santa Monica, CAStanford Health Care· Stanford, CA

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