Immunotherapy + Chemotherapy for Stomach Cancer

Phase 1

Recruiting

Led By Travis E. Grotz, M.D.

Research Sponsored by Mayo Clinic

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 from date of study entry to date of death or last follow up, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests combining aldesleukin (immune-stimulator) and nivolumab (immunotherapy) w/ chemotherapy to treat gastric cancer spread to abdomen.

Who is the study for?

Adults with confirmed gastric or gastroesophageal junction adenocarcinoma that has spread to the abdominal lining, who are in relatively good health (ECOG 0-2) and have not shown non-peritoneal metastasis. They must be able to provide blood and tissue samples, return for follow-up, and meet specific blood count and organ function criteria. Pregnant or nursing individuals, those unwilling to use contraception, or those with certain prior treatments or severe concurrent diseases cannot participate.

What is being tested?

The trial is testing aldesleukin combined with nivolumab (an immune system booster) alongside standard chemotherapy drugs fluorouracil, leucovorin calcium, and oxaliplatin. The goal is to see if this combination is more effective for patients whose stomach cancer has spread to the peritoneum compared to standard treatment alone.

What are the potential side effects?

Possible side effects include typical chemotherapy reactions like nausea, fatigue, hair loss; immune-related issues such as rash or thyroid problems from nivolumab; and flu-like symptoms from aldesleukin such as fever and chills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of study entry to date of death or last follow up, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of study entry to date of death or last follow up, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of study entry to date of death or last follow up, assessed 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.

Secondary study objectives

Histological response of the peritoneal metastasis

Overall survival

Progression free survival

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: Treatment (aldesleukin, nivolumab, chemotherapy)Experimental Treatment11 Interventions

Patients receive aldesleukin IP over at least 40 minutes on days 1 and 8 of each cycle. Patients also receive standard of care nivolumab IV over 30 minutes on day 1, leucovorin calcium IV over 2 hours on day 1, oxaliplatin IV over 2 hours on day 1, and flurouracil IV continuously over 46 hours on days 1-3 for each cycle. Cycles repeat every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo diagnostic laparoscopy with biopsy, PET/CT or PET/MRI, and collection of blood and tissue samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorouracil

2014

Completed Phase 3

~11700

Leucovorin Calcium

2011

Completed Phase 3

~12500