WithdrawnPhase 2

A Phase II Study Evaluating an Organ Preservation Strategy Using Immune Checkpoint Blockade for Participants With Primary Colorectal or Gastroesophageal Cancer

Stopped: PI left NIH.

United States0Started 2025-09-09

Plain-language summary

Background: People with colorectal cancer (CRC) or gastroesophageal cancer (GEC) must often have major surgery to remove tumors from the esophagus, stomach, colon, or rectum. These surgeries can have adverse effects on their quality of life. Researchers want to know if one or two approved drugs (nivolumab with or without ipilimumab) can help people with CRC or GEC delay or avoid surgery. Objective: To test 1 or 2 drugs in people with CRC or GEC. Eligibility: People aged 18 years and older with CRC or GEC. People with GEC must also have changes in a particular gene. Design: Participants will visit the clinic about 15 times over the first 2 years. Each visit will last 4 to 8 hours. Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans. Small samples of tissue will be collected from their upper or lower digestive tract where the tumor is located. Both ipilimumab and nivolumab are administered through a tube attached to a needle inserted into a vein in the arm. Some participants will receive both drugs. Some will receive only nivolumab. Treatment will be given once every 3 weeks for up to 8 cycles up to (24 weeks). Participants will be evaluated every 6 weeks. Those who are responding well will continue with the drug treatments. If their disease progresses, they will go to surgery. After treatment ends, participants will have follow-up visits every 6 months for up to 5 years....

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 …

What they're measuring

Clinical complete response (CR) or near-complete response (nCR)

Timeframe: 6, 12 18 and 24 weeks

Trial details

NCT IDNCT06410534

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-09-09