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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Control Rate
Secondary outcome measures
Median Overall Survival
Median Progression free Survival
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
2,933 Previous Clinical Trials
13,198,401 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,129,984 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What maladies are typically alleviated through Nivolumab administration?
"Nivolumab can be utilized to combat previous anti-angiogenic therapy, malignant tumours, and inoperable melanoma."
Answered by AI
What is the current enrollment tally for this trial?
"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial, launched on May 10th 2017 is still actively looking for 80 volunteers to be recruited from one medical centre."
Answered by AI
Are participants being accepted for enrollment in this trial at present?
"According to the reports listed on clinicaltrials.gov, this research is actively seeking participants. The trial was made available for public viewing on May 10th 2017 and has been revised as recently as September 7th 2022."
Answered by AI
What adverse effects might patients experience while taking Nivolumab?
"There is some evidence that Nivolumab can be safely administered, so it was given a score of 2 on our scale. This drug has yet to garner data in support of its efficacy when used therapeutically."
Answered by AI
Has Nivolumab been tested on participants in prior research studies?
"Currently, there are 86 Phase 3 trials in progress investigating Nivolumab and 765 studies overall. While most of these tests take place in Pittsburgh, Pennsylvania, the drug is being trialed at 42707 locations worldwide."
Answered by AI
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