Trial comparing treatments for Advanced Esophageal Adenocarcinoma
Official title mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
ClinicalTrials.gov ID: NCT05677490
What this study is testing
What is Fluorouracil?
An investigational chemotherapy drug being studied for advanced esophageal adenocarcinoma. It is designed to stop cancer cells from making DNA.
Also referred to as 5-FU.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see which treatment, mFOLFIRINOX or mFOLFOX, each given with or without nivolumab, works better at shrinking tumors in patients with advanced, unresectable, or metastatic HER2‑negative cancer of the esophagus, GEJ, or stomach.
- Who it's for
- Adults who have advanced, unresectable, or metastatic HER2‑negative esophageal, gastroesophageal junction, or gastric adenocarcinoma.
- What's involved
- Participants will receive either the mFOLFIRINOX or mFOLFOX chemotherapy regimen, and some will also receive the immunotherapy drug nivolumab. Treatment will involve regular hospital visits for drug infusions, blood tests, and imaging scans to monitor the cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists...
- Stage: unresectable or metastatic
- Tumor site: esophagus, gastroesophageal junction, or stomach
- Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- No prior systemic treatment for unresectable or metastatic disease
See the full eligibility criteria
- Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology [JCO]...
- Stage: unresectable or metastatic
- Tumor site: esophagus, gastroesophageal junction, or stomach
- Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- No prior systemic treatment for unresectable or metastatic disease
- Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects \ Therefore, for women of childbearing potential only, a negative serum or urine pregnancy...
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Creatinine =\ = 30 mL/min
- Total bilirubin =\< 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (in patients with liver metastasis: =\< 5 x ULN if clearly attributable to liver metastases)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- On effective anti-retroviral therapy
- Undetectable HIV viral load by standard clinical assay =\< 6 months of registration
- No known Gilbert's syndrome or known homozygosity for UGAT1A1\ 28 polymorphism
- No baseline grade \>= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality
- No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system...
- No allogeneic tissue/organ transplant
- Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors
- Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration.
- Patients must not have a condition requiring systemic treatment with either corticosteroids (\>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration.
- Patients must not have a history of noninfectious pneumonitis requiring steroids
- Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible
The study team makes the final eligibility decision.
Where it is enrolling
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Kingman, Arizona, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Antioch, California, United States
- Arroyo Grande, California, United States
- Auburn, California, United States
- Berkeley, California, United States
- Burbank, California, United States
- Burlingame, California, United States
- Cameron Park, California, United States
- Castro Valley, California, United States
- Costa Mesa, California, United States
- Davis, California, United States
- Dublin, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
+ 414 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Kingman, Arizona, United States; Fort Smith, Arkansas, United States; Little Rock, Arkansas, United States; Antioch, California, United States and 428 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.