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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

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I had surgery for cancer with clear margins but still have some disease left.

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I finished chemo and radiation before surgery.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to 1, 2 and 3 years later

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%

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

Hypertension

Bronchitis

Dehydration

Hyperkalaemia

Chills

Blood alkaline phosphatase increased

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

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

Small intestinal haemorrhage

Cancer pain

Neoplasm progression

Pneumothorax

Atrial flutter

Bone pain

Circulatory collapse

Confusional state

Pericardial effusion malignant

Syncope

Hypercalcaemia

Femur fracture

Superior vena cava syndrome

Bronchial obstruction

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 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,645 Previous Clinical Trials

4,130,205 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

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