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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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
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%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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
2,629 Previous Clinical Trials
4,125,742 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,869 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

Frequently Asked Questions

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

What are some of the diseases that Nivolumab has been known to help with?

"Nivolumab is most often used to target and treat malignant neoplasms; however, it has also been found helpful in treating other conditions such as unresectable melanoma, squamous cell carcinoma, metastatic esophageal adenocarcinoma."

Answered by AI

Are trial participants still being enrolled in this research?

"This particular trial is not currently enrolling patients. However, there are 749 other trials for Nivolumab that are actively recruiting participants. Out of all the cancer trials, 162 of them are admitting patients that have advanced cancer."

Answered by AI

Do we have a historical precedent for Nivolumab's effectiveness?

"There are 749 ongoing trials regarding Nivolumab, with the majority of these being Phase 3 studies. Out of all the locations conducting research on Nivolumab, 84 percent of them are located in Basel, BE."

Answered by AI

Is this research project a new one?

"There are presently 749 active studies for Nivolumab across 2347 cities and 50 countries. The earliest trial for Nivolumab was conducted in 2010 by Medarex. This Phase 1 drug approval stage involved 127 patients and completed its clinical trials in 2010. Since then, 18518 additional trials have been conducted worldwide."

Answered by AI

Are there many facilities testing this medication in North America?

"There are a total of 94 medical centres where this trial is being conducted. This includes Local Institution - 0247 in Denver, Pacific Hematology Oncology Associates in San Francisco, and Local Institution - 0250 in Tucson."

Answered by AI

What are the dangers that have been associated with taking Nivolumab?

"Nivolumab's safety is denoted by a score of 3. This means that it has gone through multiple phase 3 trials, which provides efficacy data and supports the medication's safety."

Answered by AI

Who else is applying?

What state do they live in?
Nova Scotia
How old are they?
18 - 65
What site did they apply to?
Nova Scotia Health Authority QEII Health Sciences Centre
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~92 spots leftby Mar 2025