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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
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 belowSelect...
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 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
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 • NCT0201771780%
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
2014
Completed Phase 3
~5220
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.
Understanding Immune Checkpoint Inhibitors for Effective Patient Care.
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,124,190 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
171 Previous Clinical Trials
94,942 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery for cancer with clear margins but still have some disease left.I finished chemo and radiation before surgery.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.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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