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Cancer surgery avoidance study withdrawn before it began

NCT ID NCT06410534

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study aimed to see if the immunotherapy drugs nivolumab and ipilimumab could help people with colorectal or gastroesophageal cancer avoid or delay major surgery. It was designed for adults with stage I to III cancers. However, the trial was withdrawn by the sponsor before enrolling any participants, so no data were collected.

What this could mean

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

Active substance
nivolumab and ipilimumab
What this could lead to
If this approach had worked, it could have pointed toward a way for some patients to avoid major surgery and preserve their organs.
What could go wrong
The study was withdrawn before any participants were enrolled, so no results are available. It is unknown whether the combination would have been effective or safe.

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.

Started

Sep 2025

Finished

Sep 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 120 years

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: * Participants must have biopsy-proven stage I-III colorectal cancer (CRC) \[any MMR or Tumor Mutational Burden (TMB) status\] or stage I-III gastroesophageal cancer (GEC) (MMR deficient only). * Participants with known mismatch repair protein expression by immunohistochemical staining and/ or known next-generation sequencing report of tumor mutational burden and/or microsatellite status. Note: For participants that come to NIH with an equivocal MMR status, next-generation sequencing (NGS) by TSO500 will be done at NIH. * More than four weeks must have elapsed since completion of any prior systemic therapy or radiotherapy at the time of enrollment. Participants are permitted to have undergone prior treatment with systemic chemotherapy (e.g. FOLFOX, FOLFIRI, FLOT) and/or radiotherapy. Note: Participant may have undergone minor surgical procedures within the four weeks prior to enrollment, if related major organ toxicities have recovered to \<= grade 1. * Participants must have endoscopically evaluable disease. * Age \>=18 years. * ECOG performance status =\<1. * Participants must have adequate organ and marrow function as defined below: * White Blood Cell (WBC), \>=3,000/mm\^3 * Hemoglobin \>8.0 d/dL, (transfusion permitted) * platelets, \>=100,000/mm\^3 * total bilirubin, \< 1.5 mg/dL (except in participants with Gilbert s Syndrome, who must have a total bilirubin \< 3.0 mg/dL) * AST(SGOT)/ALT(SGPT), 5.0 X institutional upper limit of normal * serum creatinine, \< 1.6 mg/dL * No pre-existing autoimmune or infectious conditions for which treatment with immune checkpoint blockade is contraindicated. * Serology * Seronegative for HIV antibody. * Seronegative for hepatitis B surface antigen and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative * Must have a negative pregnancy test. * Women of childbearing potential must be willing to must agree to use adequate contraception (surgical sterilization, partner vasectomy, hormonal or barrier method of birth control; abstinence) from the time of enrollment through 3 months after ipilimumab or for 5 months after nivolumab, whichever is later. * Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after ipilimumab or for 5 months nivolumab, whichever is later. * Ability of participant to understand and the willingness to sign a written informed consent document. * Participants with MMR proficient colon tumors must have extenuating circumstances that make surgical treatment an unacceptable option. This must be documented in the medical record. Some examples: * Religious or strong personal objections * Prior colorectal surgery, such that another resection could lead to short gut, permanent stoma or detriment to quality of life * Participant must be co-enrolled on protocol 03-C-0277 EXCLUSION CRITERIA: * Participants who are receiving any other investigational agents. * Previous treatment with checkpoint inhibitors (anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies) for the primary tumor in question. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and ipilimumab or other agents used in study. * Concomitant medications, such as steroids or other immunosuppressive agents, that have the potential to affect the activity of the study agents. * Any active or uncompensated major medical illness that would preclude major intraabdominal surgery. * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) or any immune disorder that would be a contraindication to ICB treatment. * Concurrent opportunistic infections * Tumor is causing symptomatic bowel obstruction (participants with a diverting ostomy are eligible). * History of significant autoimmune adverse events due to administration of anti-PD-1, anti-PD L1 or anti-CTLA-4 antibodies when given for prior indication. * Participants who are medically unfit to undergo major abdominal surgery. * Participants with tumors that are unable to be endoscopically evaluated. * Uncontrolled intercurrent illness that would limit compliance with study requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

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