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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
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

CheckMate 648 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.Check my eligibility
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.See study design
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.

CheckMate 648 Trial 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.

CheckMate 648 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 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%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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 648 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
~11540
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,129,862 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,553 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
~124 spots leftby May 2025
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