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Monoclonal Antibodies

Nivolumab for Colorectal Cancer (CheckMate 9X8 Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization up to the date of the first documented progression (per recist 1.1) or death due to any cause, whichever occurs first (up to 44 months)

Awards & highlights

CheckMate 9X8 Trial Summary

This trial is testing nivolumab in combination with standard chemotherapy and bevacizumab to see if it is effective in treating first-line metastatic colorectal cancer.

Eligible Conditions

Colorectal Cancer

CheckMate 9X8 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization up to the date of the first documented progression (per recist 1.1) or death due to any cause, whichever occurs first (up to 44 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization up to the date of the first documented progression (per recist 1.1) or death due to any cause, whichever occurs first (up to 44 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to the date of the first documented progression (per recist 1.1) or death due to any cause, whichever occurs first (up to 44 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)

Secondary outcome measures

Disease Control Rate (DCR) Per Blinded Independent Central Review (BICR)

Disease Control Rate (DCR) Per Investigator

Duration of Response (DoR) Per Blinded Independent Central Review (BICR)

+12 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

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%

Hypomagnesaemia

19%

Headache

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

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Hyperglycaemia

Bronchitis

Chills

Blood alkaline phosphatase increased

Dehydration

Hyperkalaemia

Hypertension

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Malaise

Pain

Musculoskeletal chest pain

Rash maculo-papular

Hypotension

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Neoplasm progression

Femur fracture

Circulatory collapse

Atrial flutter

Bronchial obstruction

Pneumothorax

Hypercalcaemia

Small intestinal haemorrhage

Bone pain

Superior vena cava syndrome

Pericardial effusion malignant

Cancer pain

Syncope

Confusional state

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

CheckMate 9X8 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment5 Interventions

Nivo + SOC

Group II: Arm BActive Control4 Interventions

SOC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxaliplatin

2011

Completed Phase 4

~2560

Nivolumab

2014

Completed Phase 3

~4750

Bevacizumab

2013

Completed Phase 4

~5280

Leucovorin

2005

Completed Phase 4

~5730

Fluorouracil

2014

Completed Phase 3

~11540

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,636 Previous Clinical Trials

4,127,347 Total Patients Enrolled

Ono Pharmaceutical Co. LtdIndustry Sponsor

154 Previous Clinical Trials

94,327 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the required health conditions enroll in this trial at this time?

"While this particular clinical trial is not enrolling new patients at the moment, that may change in the future as the study was last edited on March 2nd, 2022. According to clinicaltrials.gov, there are 2680 other trials currently looking for participants."

Answered by AI

For what medical reasons is Nivolumab often recommended?

"Nivolumab is a medication that is most often used to treat melanoma that cannot be removed through surgery. It can also be given to patients with squamous cell carcinoma, rectal carcinoma, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Are there other similar research projects that have used Nivolumab?

"Nivolumab is being trialled in 1574 different studies at the moment, with 339 of those trials currently ongoing. The majority of these live Phase 3 studies are located in Guangzhou, Guangdong; however, there are 78025 locations running Nivolumab studies in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread

2018. "An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03414983.