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Checkpoint Inhibitor

Nivolumab for Esophageal Cancer (CheckMate 577 Trial)

Wilton, Ireland
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
Pivotal Trial

Summary

This trial is testing if Nivolumab, a drug that helps the immune system fight cancer, can help cancer patients stay free of the disease longer. Nivolumab has been shown to improve survival in various cancers, including melanoma and esophageal cancer.

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.
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.
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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease
Secondary study objectives
Overall Survival (OS)
Overall Survival Rate

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.

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
2015
Completed Phase 3
~4010

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Immune checkpoint inhibitors, such as Nivolumab, work by blocking the PD-1 pathway, which cancer cells often exploit to evade the immune system. By inhibiting PD-1, these drugs enhance the body's immune response against cancer cells, allowing T-cells to recognize and destroy them more effectively. This mechanism is crucial for cancer patients as it offers a targeted approach to treatment, potentially leading to improved survival rates and durable responses. However, it also comes with unique immune-related side effects that require careful management. Understanding these mechanisms helps patients and healthcare providers make informed decisions about incorporating immunotherapy into cancer treatment plans.
Understanding Immune Checkpoint Inhibitors for Effective Patient Care.

Find a Location

Closest Location:Local Institution - 0054· Washington, United States

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,096,794 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
174 Previous Clinical Trials
95,144 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
~84 spots leftby Dec 2025