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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06410534
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — DRUG
    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
  • ipilimumab — DRUG
    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

Study Details

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....

Key Dates

Start date
Sep 9, 2025
Status verified
Sep 2025
Primary completion
Sep 9, 2025
Completion
Sep 9, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1: nivolumab and ipilimumab
    Nivolumab (3 mg/kg) every 3 weeks for up to an initial 4 cycles (an additional 4 cycles may be given depending on response, for a total of 8 cycles); low-dose ipilimumab at 1 mg/kg every other cycle (every 6 weeks) for up to an initial 2 doses (an additional 2 doses may be given depending on response, for a maximum of 4 doses).
  • Experimental: 2: nivolumab
    Nivolumab (3 mg/kg) every 3 weeks for up to an initial 4 cycles (an additional 4 cycles may be given depending on response, for a total of 8 cycles).

Primary Outcome Measure

Clinical complete response (CR) or near-complete response (nCR) [ Time Frame: 6, 12 18 and 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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