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Checkpoint Inhibitor
Nivolumab + Ipilimumab + Radiation for Colorectal Cancer
Phase 2
Waitlist Available
Led By Theodore S 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
Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal origin
One previously unirradiated measurable lesion amenable to radiotherapy 8 Gy x 3 and can meet dose constraints, and another unirradiated measurable lesion > 1 cm in size (>15 mm for nodal disease) outside the radiation field that can be used as measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of the treatment until disease progression/recurrence, up to 5 years
Awards & highlights
Study Summary
This trial is being done to study the effects of the combination of ipilimumab, nivolumab, and radiation therapy in people with metastatic microsatellite stable colorectal cancer.
Who is the study for?
Adults over 18 with metastatic microsatellite stable colorectal cancer who've tried or can't have standard treatments. They must not be pregnant, breastfeeding, or planning to conceive soon. Participants need a good performance status and normal organ/marrow function. Those with severe allergies to monoclonal antibodies, active autoimmune diseases (with some exceptions), recent radiation therapy, or uncontrolled illnesses are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of two immunotherapy drugs—Nivolumab and Ipilimumab—with Radiation Therapy in patients with colorectal cancer that has spread and doesn't respond well to certain genetic therapies. The goal is to see if this combo helps more than current treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, skin rash, hormone gland problems (like thyroid issues), digestive tract symptoms (colitis), liver inflammation (hepatitis), lung issues (pneumonitis) and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of colorectal cancer confirmed by lab tests.
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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.
Select...
I have been on a stable dose of dexamethasone or similar steroid for at least 7 days.
Select...
I am older than 18 years.
Select...
My colorectal cancer's microsatellite status is known.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of the treatment until disease progression/recurrence, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of the treatment until disease progression/recurrence, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate for unirradiated lesions (ORR)
Secondary outcome measures
Disease control rate (DCR)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE 5
Overall response rate for irradiated lesions (ORR)
+2 moreSide effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab+Ipilimumab+Radiation Therapy (RT)Experimental Treatment3 Interventions
Study cycles are 6 weeks long, participants will receive:
Cycle 1: Nivolumab every 2 weeks during cycle, Ipilimumab 1x on Day 1 of cycle, and Radiation Therapy every other weekday or 2 days for a total of 3 treatments during week 1 of Cycle 1 only.
Cycles 2-4: Nivolumab every 2 weeks during each cycle, Ipilimumab 1x on Day 1 of each cycle
Cycles 5-Disease Progression: Nivolumab every 2 weeks during each cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Ipilimumab
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,000 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,463 Total Patients Enrolled
Theodore S Hong, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
157 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active tuberculosis infection.I have another cancer besides skin or in situ cervical cancer that needs treatment.I have not received a live vaccine within the last 30 days.You are expected to live for at least 3 more months.My cancer is a type of colorectal cancer confirmed by lab tests.My organ and bone marrow functions are normal as per recent tests.I am using or will use effective birth control if I'm sexually active with a woman who can become pregnant.I have at least two cancer lesions; one can be treated with radiation, and the other, larger than 1 cm, cannot.I have colorectal cancer and have been treated with or cannot tolerate 5FU, Irinotecan, and Oxaliplatin.I have received radiation therapy within the last 8 weeks.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am currently being treated for an infection.I haven't had cancer treatment in the last 14 days and have recovered from any previous treatments, except for mild neuropathy.I do not have an active autoimmune disease, except for allowed conditions like vitiligo or type I diabetes.My brain metastases are under control after radiation treatment more than 4 weeks ago.I have been on a stable dose of dexamethasone or similar steroid for at least 7 days.I do not have HIV or AIDS.I have not received anti-CTLA-4 therapy but may have had anti-PD-1 or anti-PD-L1 therapy over 6 months ago without severe side effects.I am a woman who can have children and have a negative pregnancy test.I am not on high-dose steroids or other immune-weakening drugs.I am older than 18 years.You cannot be taking any other experimental drugs or treatments.I do not have active or chronic hepatitis B or C.I have or had lung inflammation not caused by an infection.You have experienced a strong allergic reaction to any type of monoclonal antibody in the past.My colorectal cancer's microsatellite status is known.I am fully active and can carry on all my pre-disease activities without restriction.You have had an allergic reaction to any of the ingredients in the study drug.I am using birth control to prevent pregnancy for 5 months after my last treatment dose.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab+Ipilimumab+Radiation Therapy (RT)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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 is the aggregate count of individuals enrolled in this clinical experiment?
"At present, this clinical trial has suspended recruitment. This study was initially posted on October 5th 2020 and last modified on September 7th 2022. For possible alternatives, 859 trials for colorectal cancer and 765 studies using Ipilimumab are actively enrolling participants."
Answered by AI
What earlier investigations have been conducted concerning Ipilimumab?
"At present, there are 86 phase 3 trials and 679 other studies centered around Ipilimumab. Most of these clinical sites can be found in Pittsburgh, Pennsylvania; however, globally 42755 medical centres are presently running experiments with this medication."
Answered by AI
Has the Food and Drug Administration given its stamp of approval for Ipilimumab?
"The safety of Ipilimumab was estimated by our team to be a 2, given that this is only in Phase 2. Thus far, there are some pieces of evidence supporting its security; however, efficacy still needs to be established."
Answered by AI
Are any new participants being brought into this experiment?
"Based on the clinicaltrials.gov registry, this medical study has ceased recruitment since September 7th 2022 and is no longer accepting patients at this time. Nonetheless, 1,624 other trials are actively recruiting new participants who wish to join a medical trial."
Answered by AI
What clinical indications are commonly addressed by Ipilimumab?
"Ipilimumab is typically taken following anti-angiogenic therapy and can be used to address various malignancies such as melanoma, squamous cell carcinoma."
Answered by AI
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