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

NCT06410534 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-09-11

No results posted yet for this study

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....

Conditions

Interventions

DRUG

nivolumab

Nivolumab will be dosed at 3 mg/kg and given as an IV over 30-60 minutes on day 1 of each cycle. It will be administered every 3 weeks (21 days) for up to 8 cycles

DRUG

ipilimumab

Ipilimumab will be dosed at 1 mg/kg and given as an IV over approximately 30 minutes on day 1 of every other cycle (every 6 weeks or 42 days) for up to 4 doses

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nicholas D Klemen, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2025-09-09
Completion
2025-09-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06410534 on ClinicalTrials.gov