Experimental combo therapy shows promise in advanced cancers, but trial halted early

NCT ID NCT04916002

Terminated Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether injecting vidutolimod directly into tumors plus giving cemiplimab through a vein could shrink cancers that have spread. The trial included 77 people with several types of advanced cancer. Unfortunately, the study was stopped early, so we have less information than hoped. The main goal was to see how many patients' tumors responded and to check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: vidutolimod (CMP-001) and cemiplimab (Libtayo)
What this could lead to: If successful, this combination could offer a new treatment option for several advanced cancers by boosting the immune system to attack tumors.
What could go wrong: The trial was terminated early, so results are limited. It is unclear if the combination is effective or safe; side effects from immune activation can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

basal cell carcinoma cutaneous neuroendocrine carcinoma Neoplasm Metastasis non-small cell lung carcinoma oropharynx squamous cell carcinoma skin squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BASAL CELL CARCINOMA CUTANEOUS SQUAMOUS CELL CARCINOMA MERKEL CELL CARCINOMA NON-SMALL CELL LUNG CANCER OROPHARYNX SQUAMOUS CELL CARCINOMA TRIPLE NEGATIVE BREAST CANCER

Contacts and locations

Locations

City of Hope

Duarte, California, 91010, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dartmouth Clinical Trial Office

Lebanon, New Hampshire, 03756, United States
East Carolina University

Greenville, North Carolina, 27858, United States
Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia
GenesisCare USA

Jacksonville, Florida, 32204, United States
Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Norton Cancer Institute

Louisville, Kentucky, 40202, United States
OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States
Ohio State University

Columbus, Ohio, 43210, United States
Oncology Consultants

Houston, Texas, 77030, United States
Orlando Health Cancer Institute

Orlando, Florida, 32806, United States
Peter MacCallum Cancer Centre (PMCC) and The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia
Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia
St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia
UC San Diego Moores Cancer Center

La Jolla, California, 92037-0845, United States
University of Alabama

Birmingham, Alabama, 35294, United States
University of California

Los Angeles, California, 90095, United States
University of Iowa

Iowa City, Iowa, 52242, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States
University of Utah Huntsman Cancer Center

Salt Lake City, Utah, 84112, United States
University of Washington

Seattle, Washington, 98109, United States
VA Maryland Health Care System

Baltimore, Maryland, 20814, United States

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