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Chemotherapy
Nivolumab + FOLFOX + Regorafenib for Esophageal Cancer
Phase 2
Waitlist Available
Led By Yelena Janjigian, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying the combination of three drugs as a potential treatment for HER2-negative metastatic esophagogastric cancer.
Who is the study for?
Adults with HER2-negative metastatic esophagogastric cancer can join this trial. They should have adequate organ function, no severe neuropathy, and their disease must be visible on scans. Excluded are those with HER2-positive cancer, difficulty swallowing pills, recent major surgery or radiation, prior regorafenib treatment, certain autoimmune diseases unless specified exceptions apply, active infections like HIV or hepatitis B/C, uncontrolled heart conditions or blood pressure issues.
What is being tested?
The study is testing a combination of nivolumab (an immune system booster), FOLFOX chemotherapy (a DNA-damaging drug trio), and regorafenib (a growth-blocking drug) to see if they work better together than standard treatments for advanced stomach cancers that don't respond to HER2-targeted therapies.
What are the potential side effects?
Possible side effects include immune-related reactions due to nivolumab potentially affecting healthy organs; nerve damage from oxaliplatin in FOLFOX; fatigue and digestive problems from chemotherapy drugs; and liver issues or high blood pressure from regorafenib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
6-month progression free Survival
Side effects data
From 2021 Phase 3 trial • 1844 Patients • NCT0306845538%
Fatigue
37%
Diarrhoea
37%
Pruritus
29%
Headache
28%
Rash
24%
Hypothyroidism
24%
Nausea
20%
Hyperthyroidism
18%
Arthralgia
18%
Cough
18%
Asthenia
15%
Alanine aminotransferase increased
13%
Lipase increased
13%
Pyrexia
12%
Constipation
12%
Aspartate aminotransferase increased
12%
Decreased appetite
12%
Nasopharyngitis
11%
Abdominal pain
11%
Dry mouth
11%
Vomiting
11%
Myalgia
10%
Hypophysitis
10%
Insomnia
10%
Back pain
9%
Amylase increased
8%
Dyspnoea
8%
Upper respiratory tract infection
7%
Dizziness
6%
Adrenal insufficiency
6%
Abdominal pain upper
6%
Infusion related reaction
6%
Hyperglycaemia
6%
Oropharyngeal pain
6%
Blood creatine phosphokinase increased
6%
Influenza like illness
5%
Vitiligo
5%
Hypertension
5%
Pain in extremity
3%
Colitis
3%
Anxiety
2%
Immune-mediated enterocolitis
2%
Autoimmune hepatitis
2%
Basal cell carcinoma
2%
Malignant neoplasm progression
1%
Squamous cell carcinoma
1%
Autoimmune colitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Erysipelas
1%
Pneumonia
1%
Melanoma recurrent
1%
Pneumonitis
1%
Sarcoidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Ipi
Arm B: Nivo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab Combined With FOLFOX and RegorafenibExperimental Treatment3 Interventions
Each treatment cycle consists of 28 days. Patients will initially receive induction therapy with regorafenib (80 mg on days 1-21 of the 28-day cycle) and nivolumab (240 mg on days 1 and 15 of the 28-day cycle). Starting on cycle 2, day 1, patients will also receive FOLFOX chemotherapy with oxaliplatin (85 mg/m2 IV), leucovorin (400 mg/m2 IV), 5-FU (400 mg/m2 IV bolus), and 5-FU (2400 mg/m2/day continuous IV infusion over 48 h). If the patient is not a good candidate for induction regorafenib and nivolumab (i.e. symptomatic from a large burden of disease), 5-FU and oxaliplatin can be added during cycle 1 at the treating physician's discretion. 39 Patients will continue with this regimen until disease progression, unacceptable toxicity, or development of serious intercurrent illness. Treatment will be performed on the scheduled day (±7-day treatment window).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~6290
regorafenib
2014
Completed Phase 3
~1310
Find a Location
Who is running the clinical trial?
BayerIndustry Sponsor
2,277 Previous Clinical Trials
25,540,990 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,799 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,032 Total Patients Enrolled
Yelena Janjigian, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
941 Total Patients Enrolled
Media Library
Esophageal Cancer Patient Testimony for trial: Trial Name: NCT04757363 — Phase 2