Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Melanoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cemiplimab

Interferon-beta

Antineoplastic Agents, Immunological

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.

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.

(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.

VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit

Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.

Jennifer boughton

Neta Shanwetter Levit, MPH

Barbara Johnson

Mario Sznol, MD

Ashley Kaufman

Christy Estevez

Jose Lutzky, MD

Ashley Poliak Hammad, MSN

Thomas Marron, MD

Trisha Wise-Draper, MD, PhD

Staci Vogel

Steven Powell, MD

Alexssandra Lima, MD

Henrique Souza Maia

Caio A Dantas, MD

Alice Bexon, MD

Stephen J Russell, MD, Ph.D.

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.

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.

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

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

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 expression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients	NCT04291105	Melanoma Head and Neck S... Colo-rectal Can...	VV1 Cemiplimab	18 Years -	Vyriad, Inc.
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients	NCT04291105	Melanoma Head and Neck S... Colo-rectal Can...	VV1 Cemiplimab	18 Years -	Vyriad, Inc.

Spots Global Cancer Trial Database for vv1

Every month we try and update this database with for vv1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vv1

Every month we try and update this database with for vv1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vv1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.