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Chemotherapy

Chemotherapy + Immunotherapy for Esophageal and Gastric Cancer

Phase 3

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

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 up to 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares chemo drugs to treat advanced gastroesophageal cancer. Some get chemo plus immunotherapy drug to try to shrink tumor and extend life.

Who is the study for?

Adults with advanced, inoperable or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma can join. They shouldn't have had previous treatment for their advanced cancer but may have had prior therapy if completed over a year ago. Participants need adequate organ function and no active autoimmune diseases requiring recent treatment. Those with certain heart conditions or infections like HIV must meet specific criteria.

What is being tested?

The trial compares mFOLFIRINOX (a combination of chemotherapy drugs) to mFOLFOX (another chemo combo), both aiming to stop tumor growth by killing cells or preventing cell division. Some patients will also receive Nivolumab, an immunotherapy drug designed to boost the immune system's response against cancer cells.

What are the potential side effects?

Chemotherapy may cause nausea, fatigue, hair loss, increased risk of infection due to low blood counts, and nerve damage leading to numbness or tingling. Immunotherapy with Nivolumab might lead to immune-related side effects such as inflammation in various organs including the lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies), and skin rash.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS)

Secondary study objectives

Overall response rate

Patient reported outcomes

Progression-free survival (PFS)

Other study objectives

Exploratory correlative markers

Feasibility and compliance of intervention

Incidence of adverse events

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (mFOLFIRINOX, nivolumab)Experimental Treatment9 Interventions

Patients receive fluorouracil IV, leucovorin calcium IV, oxaliplatin IV, and irinotecan IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.

Group II: Arm II (mFOLFOX, nivolumab)Active Control8 Interventions

Patients receive fluorouracil IV, leucovorin calcium IV, and oxaliplatin IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740