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Chemotherapy

Immunotherapy + Chemotherapy for Esophageal Cancer (CheckMate 648 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
Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
Must not have
Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus
Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 40 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if adding immunotherapy to chemotherapy can help people with esophageal cancer live longer or without disease progression.

Who is the study for?
This trial is for adults with esophageal cancer that's inoperable, recurrent, or metastatic. Participants must be able to perform light activities and provide a tumor tissue sample. It excludes those with symptomatic brain/spinal tumors, serious medical conditions, active infections, HIV/AIDS, hepatitis B/C infection, or autoimmune diseases.
What is being tested?
The study compares the effectiveness of Nivolumab plus Ipilimumab or combined with Fluorouracil and Cisplatin against just Fluorouracil plus Cisplatin in extending life without disease progression in esophageal cancer patients.
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs (like colitis), skin issues (rash), hormone gland problems (thyroid dysfunction), infusion reactions from the drugs administered intravenously, fatigue, nausea from chemotherapy agents like Fluorouracil and Cisplatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is a type of esophageal cancer called squamous cell or adenosquamous carcinoma.
Select...
My esophageal cancer is advanced, cannot be surgically removed, or treated with the intent to cure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have tested positive for hepatitis B or C.
Select...
I have cancer in my brain or spinal cord that shows symptoms or needs treatment.
Select...
I have tested positive for HIV/AIDS.
Select...
I do not have any serious or uncontrolled health issues or active infections.
Select...
I have an active autoimmune disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 40 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 40 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS) in Participants With Tumor Cell PD-L1
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1
Secondary study objectives
Objective Response Rate (ORR) as Assessed by BICR
Overall Survival (OS) in All Randomized Participants
Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR

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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Group II: Nivolumab + Cisplatin + FluorouacilExperimental Treatment3 Interventions
Group III: Cisplatin + FluorouracilActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11700
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420
Cisplatin
2013
Completed Phase 3
~3120

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,101 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
174 Previous Clinical Trials
95,292 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03143153 — Phase 3
Cancer Research Study Groups: Cisplatin + Fluorouracil, Nivolumab + Ipilimumab, Nivolumab + Cisplatin + Fluorouacil
Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03143153 — Phase 3
Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03143153 — Phase 3
~115 spots leftby Dec 2025
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