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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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