New cocktail aims to shrink tough colorectal tumors

NCT ID NCT06948448

Recruiting now Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jan 06, 2026 · Last updated Jun 22, 2026 · Updated 33 times

Summary

This Phase 2 trial tests whether adding an experimental drug (ONO-4578) and an immunotherapy (Opdivo) to standard chemotherapy and bevacizumab can shrink tumors better than standard care alone in people with advanced colorectal cancer that is not MSI-high and has PD-L1 expression. About 144 participants will receive one of two doses of the new combination. The main goals are to see how many patients respond and to monitor side effects.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

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Locations

Advent Health
RECRUITING

Orlando, Florida, 32803, United States
Azienda Socio Sanitaria Territoriale Niguarda
RECRUITING

Milan, Italy, Italy
Baylor Scott & White Medical Center
RECRUITING

Temple, Texas, 76508, United States
Blue Ridge Cancer Care
RECRUITING

Salem, Virginia, 24153, United States
CHU Besançon - Hôpital Jean Minjoz
RECRUITING

Besançon, Doubs, France
CHU Bordeaux - Hôpital Haut-Lévêque
RECRUITING

Pessac, Gironde, France
CHU Poitiers - Hôpital la Milétrie
RECRUITING

Poitiers, Vienne, France
Centre Leon Berard
RECRUITING

Lyon, Rhone, France
Chru De Nantes Hotel-Dieu
RECRUITING

Nantes, Loire Atlantique, France
Hospital General Universitario de Valencia
RECRUITING

Valencia, Valencia, Spain
Hospital Regional Universitario de Malaga
RECRUITING

Málaga, Spain, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, Madrid, Spain
Hospital Universitario Reina Sofia
RECRUITING

Córdoba, Córdoba, Spain
Hospital Universitario Virgen del Rocio
RECRUITING

Seville, Sevilla, Spain
Hosptial Universitari Vall d'Hebron
RECRUITING

Barcelona, Barcelona, Spain
Hôpital Européen Georges Pompidou
RECRUITING

Paris, Paris, France
Hôpital Saint-Antoine
RECRUITING

Paris, Paris, France
Hôpital de la Timone
RECRUITING

Marseille, Marseille, France
IOV-Istituto Oncologico
RECRUITING

Padova, Padova, Italy
Istituto Clinico Humanitas
RECRUITING

Milan, Italy, Italy
Istituto Europeo di Oncologia
RECRUITING

Milan, Italy, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
RECRUITING

Naples, Napoli, Italy
Kobe City Medical Center General Hospital
RECRUITING

Hyōgo, Kobe-shi, Japan
May Clinic Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
Mayo Clinic Arizona
RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic Florida
RECRUITING

Jacksonville, Florida, 32224, United States
National Hospital Organization Osaka National Hospital
RECRUITING

Osaka, Osaka-shi, Japan
Osaka General Medical Center
RECRUITING

Osaka, Osaka-shi, Japan
Osaka International Cancer Institute
RECRUITING

Osaka, Osaka-shi, Japan
Princess Margaret Cancer Centre- University Health Network
RECRUITING

Toronto, Ontario, M5G 2M9, Canada
Rocky Mountain Cancer Centers, LLP
RECRUITING

Lone Tree, Colorado, 80124, United States
The Ohio State University Comprehensive Cancer Center
RECRUITING

Columbus, Ohio, 43221, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
USC Norris Comprehensive Cancer Center
RECRUITING

Los Angeles, California, 90033, United States
Virginia Oncology Associates
RECRUITING

Norfolk, Virginia, 23502, United States

What this could mean

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

Active substance

ONO-4578 (an experimental drug) combined with nivolumab (Opdivo), chemotherapy (mFOLFOX6), and bevacizumab

What this could lead to

If successful, this could offer a new first-line treatment option for people with a specific type of advanced colorectal cancer, potentially improving tumor shrinkage rates.

What could go wrong

This is an early Phase 2 trial with only 144 participants, so results may not apply to everyone. Adding more drugs also raises the risk of side effects.

Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

COLORECTAL CANCER