Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New cocktail aims to shrink tough colorectal tumors

NCT ID NCT06948448

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 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.

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.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection * ECOG Performance Status of 0-1 * No prior systemic treatment for advanced local or mCRC * Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory Exclusion Criteria: * Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor * Participants with BRAF V600E mutation * Unable to swallow tablets. * Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis * Participants with an active, known or suspected autoimmune disease. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Other protocol-defined inclusion/exclusion criteria apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Uni degli Studi Della Campania Lugi Vanvitelli

    RECRUITING

    Naples, Napoli, Italy

  • 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

  • Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona)

    RECRUITING

    Badalona, Barcelona, Spain

  • 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

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, Canada

  • 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

  • The Ottawa Hospital Cancer Centre

    RECRUITING

    Ottawa, Ontario, Canada

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.