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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
6-month progression free Survival

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455
38%
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%
Autoimmune colitis
1%
Squamous cell carcinoma
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

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
~4960
regorafenib
2014
Completed Phase 3
~830

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,238 Previous Clinical Trials
25,332,679 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,816 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,993 Total Patients Enrolled

Media Library

Esophageal Cancer Patient Testimony for trial: Trial Name: NCT04757363 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain nivolumab's main function?

"Nivolumab is a medication used to treat cancerous growths. Additionally, it can be utilized as treatment for unresectable melanoma, squamous cell carcinoma of the skin, and metastatic esophageal adenocarcinoma."

Answered by AI

Are researchers looking for more participants in this trial?

"The trial is currently recruiting patients, according to the information available on clinicaltrials.gov. This study was originally posted on February 11th, 2021 and was last updated November 15th, 2022. There are 43 participants enrolled across 7 sites."

Answered by AI

Has the United States Food and Drug Administration cleared nivolumab for public use?

"So far, nivolumab has only been proven safe in Phase 2 trials. There is no data yet supporting its efficacy."

Answered by AI

Are there any other ongoing studies that use nivolumab?

"At this time, 1130 different clinical trials are investigating nivolumab with 208 of those being in Phase 3. The largest concentration of these studies is located Woolloongabba, Queensland; however, there are 54730 total locations running nivolumab trials."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

How long do screening visits take? How long do screening visits take? Have you tracked any results yet?
PatientReceived no prior treatments

Why did patients apply to this trial?

I had 8 months of chemo ( FLOT II believe) followed by attempted total gastrectomy. The tumor had advanced along the esophagus into the chest precluding a safe margin of resection. My spleen and tail of pancreas were removed but no stomach. I also received HIPEC.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer
2021. "A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04757363.
All > Debbies Dream > Gastric Cancer
~7 spots leftby Feb 2025
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