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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 belowSelect...
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:Select...
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have not had specific immune therapies if I have colorectal cancer, but it's okay for pancreatic cancer.My organ and bone marrow functions are normal as per recent tests.I've been on a stable dose of dexamethasone (2 mg or less) for the last week.My cancer is confirmed to be either colorectal or pancreatic adenocarcinoma.I am older than 18 years.I am fully active and can carry on all pre-disease activities without restriction.I have at least two cancer lesions; one can be treated with radiation, and the other, larger than 1 cm, cannot.I have another cancer besides skin or in situ cervical cancer that is getting worse or needs treatment.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I haven't had cancer treatment in the last 14 days and have no major side effects from past treatments.I have a history of active tuberculosis.I do not have HIV or AIDS.I have had treatments with 5FU, Irinotecan, and Oxaliplatin for colorectal cancer or cannot take them due to health reasons.My colorectal cancer's microsatellite status is documented.My pancreatic cancer has worsened despite one chemotherapy treatment.I do not have an active autoimmune disease, except for allowed conditions.My brain metastases are under control after radiation treatment.You have a positive test for hepatitis B or hepatitis C, which means you have an ongoing infection.You are expected to live for more than 3 months.You had a serious allergic reaction to a type of medicine called monoclonal antibody in the past.I have or had lung inflammation not caused by an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab+Ipilimumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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