Durvalumab + Tremelimumab for Stomach and Esophageal Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByFarshid Dayyani

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of California, Irvine

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.

Eligibility Criteria

This trial is for individuals with untreated esophageal, gastroesophageal junction, or gastric adenocarcinomas that haven't spread elsewhere and have ARID1A mutations. Participants must be willing to undergo biopsy procedures.

Inclusion Criteria

My cancer in the esophagus or stomach has a specific genetic change.

I have not received any treatment for my condition.

I am 18 years old or older.

My cancer is not MSI-High.

I can take care of myself and am up and about more than half of my waking hours.

I weigh more than 66 pounds.

My stomach cancer has not spread and cannot be surgically removed.

Exclusion Criteria

My cancer has spread to other parts of my body.

I cannot or will not have a biopsy to get tissue samples.

Participant Groups

The trial tests the effectiveness of a single dose of two immune checkpoint inhibitors, Durvalumab and Tremelimumab, in increasing T cells within tumors for certain stomach cancers.

1Treatment groups

Experimental Treatment

Group I: Tremelimumab and DurvalumabExperimental Treatment2 Interventions

Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1