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Chemotherapy
Nivolumab + Ipilimumab for Colorectal Cancer (CheckMate 8HW Trial)
Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1
Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
CheckMate 8HW Trial Summary
This trial is testing nivolumab with or without ipilimumab as a treatment for metastatic colorectal cancer in patients with microsatellite instability high or mismatch repair deficiency. The goal is to see if the combination therapy is more effective than nivolumab alone and if either treatment is more effective than chemotherapy.
Who is the study for?
This trial is for adults with a specific type of advanced colorectal cancer that's not suitable for surgery. Participants must have tumors with high microsatellite instability or mismatch repair deficiency, and be in good physical condition (ECOG ≤1). People who've had certain immune diseases, lung conditions, or are HIV positive cannot join.Check my eligibility
What is being tested?
The study tests the effectiveness of Nivolumab alone or combined with Ipilimumab against standard chemotherapy options like Irinotecan and Oxaliplatin. It measures how long patients live without their cancer getting worse, their overall response to treatment, and survival time.See study design
What are the potential side effects?
Nivolumab and Ipilimumab can cause immune-related side effects such as inflammation in various organs, skin rash, hormone gland problems (like thyroid), fatigue, and may worsen pre-existing autoimmune diseases.
CheckMate 8HW Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My tumor is identified as MSI-H or dMMR.
CheckMate 8HW Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
PFS by BICR (arm B vs C, 1L, centrally confirmed)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)
Secondary outcome measures
ORR by BICR (arm A vs C, 1L, centrally confirmed)
ORR by BICR (arm B vs A, 1L, centrally confirmed)
ORR by BICR (arm B vs C, 1L, centrally confirmed)
+16 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
CheckMate 8HW Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Nivolumab + Ipilimumab CombinationExperimental Treatment2 Interventions
Specified dose on specified days
Group II: Arm A: Nivolumab MonotherapyExperimental Treatment1 Intervention
Specified dose on specified days
Group III: Arm C: Investigator's Choice ChemotherapyActive Control6 Interventions
Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,692 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,129,233 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all pre-disease activities without restriction.You have an autoimmune disease that is currently active, known, or suspected.My colorectal cancer has returned or spread, and I haven't had chemotherapy or targeted therapy for it.There are other requirements that you must meet or not meet to participate in this study, as determined by the study guidelines.I have had interstitial lung disease or pneumonitis.My tumor is identified as MSI-H or dMMR.My colorectal cancer has returned or spread and cannot be removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Nivolumab Monotherapy
- Group 2: Arm B: Nivolumab + Ipilimumab Combination
- Group 3: Arm C: Investigator's Choice Chemotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Has Nivolumab been cleared by the FDA?
"There is preliminary data affirming Nivolumab's efficacy and extensive data supporting its safety, so it received a score of 3."
Answered by AI
Is this clinical trial taking place in several locations throughout the United States?
"Currently, this trial is underway at 20 different sites, which include locations such as Sacramento, Roanoke and Edmonton. To reduce the amount of travelling required, patients are encouraged to enroll at the location nearest to them."
Answered by AI
Are there previous findings with Nivolumab?
"The first clinical trial for nivolumab was conducted over 20 years ago at Peter MacCallum Cancer Centre. In total, there have been 2672 completed studies. Of these, 1807 are actively recruiting patients. The majority of these are located in Sacramento, California."
Answered by AI
What are the common conditions that Nivolumab is used to manage?
"Nivolumab is a common treatment for unresectable melanoma. However, it can also be used to manage other oncological conditions, such as squamous cell carcinoma, a high risk of cancer recurrence, and intolerance to irinotecan."
Answered by AI
If I may ask, how many individuals are currently enrolled in this experiment?
"This study requires 831 individuals that fit the pre-determined eligibility criteria. Potential participants can inquire about this trial at University of California Davis Health-University of California Davis Comprehensive Cancer Center in Sacramento, California and Oncology & Hematology Associates Of Southwest Virginia, Inc. in Roanoke, Virginia."
Answered by AI
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