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Checkpoint Inhibitor

Ipilimumab + Nivolumab for Colorectal Cancer

Phase 2

Recruiting

Led By Nicholas D Klemen, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have adequate organ and marrow function

Participants must have biopsy-proven stage I-III colorectal cancer (CRC) or stage I-III gastroesophageal cancer (GEC)

Must not have

Any active major medical illness precluding major intraabdominal surgery

Primary immunodeficiency or immune disorder contraindicating ICB treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until 30 days after documented progressive disease

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test one or two drugs (nivolumab with or without ipilimumab) to see if they can help people with colorectal or gastroesophageal cancer delay or

Who is the study for?

This trial is for adults with colorectal or gastroesophageal cancer. For gastroesophageal cancer, a specific gene change is required. Participants will undergo numerous clinic visits and tests including blood, urine, imaging scans, and tissue samples from the digestive tract.

What is being tested?

The study evaluates if nivolumab alone or combined with ipilimumab can delay or avoid surgery in patients. Treatments are given through an IV every 3 weeks for up to 24 weeks. Patients responding well may continue treatment; otherwise, they'll consider surgery.

What are the potential side effects?

Nivolumab and ipilimumab might cause immune-related reactions affecting various organs, infusion-related discomforts, fatigue, gastrointestinal issues like diarrhea or colitis, skin rash and potential hormonal gland problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organs and bone marrow are working well.

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I have been diagnosed with early-stage colorectal or gastroesophageal cancer.

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My cancer has been tested for specific genetic markers.

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It has been over 4 weeks since my last cancer treatment.

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I am 18 years old or older.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses that would prevent me from having major surgery in my abdomen.

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I have an immune system disorder that prevents me from receiving ICB treatment.

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My tumor cannot be checked with a scope.

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My tumor is causing blockage in my intestines.

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I am not fit for major abdominal surgery.

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I have been treated with checkpoint inhibitors for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until 30 days after the last dose of study drugs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until 30 days after the last dose of study drugs

This trial's timeline: 3 weeks for screening, Varies for treatment, and until 30 days after the last dose of study drugs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Delay in surgery

Disease free survival (DFS)

Locoregional failure

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2: nivolumabExperimental Treatment1 Intervention

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).

Group II: 1: nivolumab and ipilimumabExperimental Treatment2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nivolumab

2016

Completed Phase 3

~6290

ipilimumab

2016

Completed Phase 3

~6380