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Checkpoint Inhibitor

Nivolumab for Esophageal Cancer (CheckMate 577 Trial)

Phase 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
Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection
Completed pre-operative chemo radiotherapy followed by surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 1, 2 and 3 years later
Awards & highlights

CheckMate 577 Trial Summary

This trial will test whether the drug Nivolumab can help people with cancer live longer without their disease coming back.

Who is the study for?
This trial is for people who've had surgery for Stage II/III esophageal or gastroesophageal junction cancer and still have some signs of the disease. They must have finished chemo radiotherapy before surgery. It's not open to those with other conditions that could interfere.Check my eligibility
What is being tested?
The study is testing if Nivolumab, an immune therapy drug, can keep cancer from coming back better than a placebo (a treatment with no active drug). Participants will be randomly assigned to receive either Nivolumab or the placebo.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs, skin rash, endocrine disorders like thyroid issues, fatigue, and infusion reactions.

CheckMate 577 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery for cancer with clear margins but still have some disease left.
Select...
I finished chemo and radiation before surgery.
Select...
My cancer is in the esophagus or where the stomach meets the esophagus, and it's at an advanced stage but not the most severe.

CheckMate 577 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 1, 2 and 3 years later
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 1, 2 and 3 years later for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease
Secondary outcome measures
Overall Survival (OS)
Overall Survival Rate

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%
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%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
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%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Pericardial effusion malignant
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
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 577 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NivolumabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,038 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,729 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02743494 — Phase 3
Cancer Research Study Groups: Nivolumab, Placebo
Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02743494 — Phase 3
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02743494 — Phase 3
~90 spots leftby Jun 2025
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