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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 belowSelect...
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 weeks3 visits
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)
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)
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 • NCT0204153357%
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%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
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%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
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
~2670
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,544 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,553 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tested positive for hepatitis B or C.I am 18 years old or older.I can walk and do light activities like housework or office work.I have cancer in my brain or spinal cord that shows symptoms or needs treatment.I have tested positive for HIV/AIDS.My cancer is a type of esophageal cancer called squamous cell or adenosquamous carcinoma.My esophageal cancer is advanced, cannot be surgically removed, or treated with the intent to cure.I do not have any serious or uncontrolled health issues or active infections.I agree to provide a sample of my tumor tissue for the study.I have an active autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Cisplatin + Fluorouracil
- Group 2: Nivolumab + Ipilimumab
- Group 3: Nivolumab + Cisplatin + Fluorouacil
Awards:
This trial has 2 awards, including:- 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.
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.
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 main conditions that Nivolumab is used to target?
"Nivolumab is most frequently given to patients with malignant neoplasms, but it has also shown efficacy in treating unresectable melanoma, squamous cell carcinoma, and rectal carcinoma."
Answered by AI
Can patients still join the trial?
"This particular clinical trial is not enrolling participants at the moment, however that information is subject to change. According to the website, this study was first posted on June 29th, 2017 and was last updated on June 13th, 2022. There are 1708 other studies that are actively recruiting patients."
Answered by AI
Can you give some examples of other times Nivolumab has been used in medical research?
"Nivolumab was first studied in 1997 and since then, there have been 1750 completed clinical trials. As of now, there are 1706 ongoing studies recruiting patients. A large number of these trials are being conducted in Tampa, Alabama."
Answered by AI
What is the total recruitment size for this trial?
"As of now, this study has ceased recruiting patients. The trial was first posted on 6/29/2017 and was last updated on 6/13/2022. However, there are presently 2 clinical trials actively recruiting patients with malignant neoplasms and 1706 studies for Nivolumab actively recruiting patients."
Answered by AI
Is Nivolumab a danger to patients?
"There is some evidence, from earlier phases of this trial, to support the efficacy of Nivolumab. Furthermore, multiple rounds of data have been collected to support its safety. Therefore, our team has rated Nivolumab as a 3 on our safety scale."
Answered by AI
What benefits does this trial hope to confer on patients?
"The primary outcome of this study, as measured by the sponsor Bristol-Myers Squibb, will be Progression-free Survival (PFS) in study participants with PD-L1 positive tumors. This study will also evaluate secondary outcomes of Overall Survival (OS), Progression-free Survival (PFS), and Objective Response Rate (ORR)."
Answered by AI
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