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Checkpoint Inhibitor

Nivolumab + Ipilimumab + Radiation for Colorectal and Pancreatic Cancer

Phase 2
Recruiting
Led By Theodore Hong, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable dose of dexamethasone 2 mg or less for 7 days prior to initiation of treatment
Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal or pancreatic origin
Must not have
Has a known history of active TB (Bacillus Tuberculosis)
Patients are excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is studying a combination of drugs as a possible treatment for certain types of cancer. The drugs are Nivolumab and Ipilimumab, and the radiation therapy is meant to target the cancer specifically.

Who is the study for?
Adults over 18 with colorectal or pancreatic cancer that's stable and haven't had certain treatments. They need a lesion for radiotherapy, another measurable one outside the radiation field, normal organ/marrow function, and an ECOG status ≤1. Women must use contraception; no severe infections or psychiatric issues that affect trial participation.
What is being tested?
The study tests Nivolumab and Ipilimumab combined with Radiation Therapy on patients with Microsatellite Stable (MSS) Colorectal Cancer, Pancreatic Cancer, or MSI High Colorectal Cancer to evaluate their effectiveness as a treatment option.
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in organs, skin rash, hormone gland problems (like thyroid), infusion reactions during drug administration, fatigue, nausea, and potential increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on a stable dose of dexamethasone (2 mg or less) for the last week.
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My cancer is confirmed to be either colorectal or pancreatic adenocarcinoma.
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I am older than 18 years.
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I am fully active and can carry on all pre-disease activities without restriction.
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I have at least two cancer lesions; one can be treated with radiation, and the other, larger than 1 cm, cannot.
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I have had treatments with 5FU, Irinotecan, and Oxaliplatin for colorectal cancer or cannot take them due to health reasons.
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My colorectal cancer's microsatellite status is documented.
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My pancreatic cancer has worsened despite one chemotherapy treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of active tuberculosis.
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I do not have HIV or AIDS.
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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I am currently being treated for an infection.
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I do not have an active autoimmune disease, except for allowed conditions.
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I have or had lung inflammation not caused by an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Control Rate
Secondary study objectives
Median Overall Survival
Median Progression free Survival

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab+IpilimumabExperimental Treatment3 Interventions
* Nivolumab will be administered intravenously 3 times per cycle * Ipilimumab will be administered intravenously once per cycle * Radiation Therapy will be administered per hospital standard
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,202 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,124,904 Total Patients Enrolled
Theodore Hong, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03104439 — Phase 2
Colorectal Cancer Research Study Groups: Nivolumab+Ipilimumab
Colorectal Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03104439 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03104439 — Phase 2
~10 spots leftby Oct 2025
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