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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
Must not have
History of interstitial lung disease or pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My tumor is identified as MSI-H or dMMR.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had interstitial lung disease or pneumonitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

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.

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
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
172 Previous Clinical Trials
94,939 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,686 Previous Clinical Trials
4,128,996 Total Patients Enrolled

Media Library

Fluorouracil (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04008030 — Phase 3
Colorectal Cancer Research Study Groups: Arm A: Nivolumab Monotherapy, Arm B: Nivolumab + Ipilimumab Combination, Arm C: Investigator's Choice Chemotherapy
Colorectal Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT04008030 — Phase 3
Fluorouracil (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04008030 — Phase 3
~71 spots leftby Jun 2025
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