Recruiting
Early Phase 1

Dual Immune Checkpoint Inhibitors

Sponsor:

UCLA

Code:

NCT06824363

Conditions

Solid Tumor, Adult

Malignant Solid Tumor

Stomach Adenocarcinoma

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tremelimumab

Durvalumab

Study Details

Brief summary:

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.

Conditions

Solid Tumor, Adult

Malignant Solid Tumor

Stomach Adenocarcinoma

Esophageal Adenocarcinoma

Study ID

NCT06824363

Start date

May 25, 2026

Status verified date

Jan, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Non metastatic GEC including locally advanced unresectable
  • Treatment naïve
  • Histologically proven adenocarcinoma of the esophagus or the stomach with ARID1a mutation either by liquid biopsy (ctDNA) or tissue NGS/WES
  • MSI-Stable or pMMR
  • Age ≥ 18 years
  • Body weight > 66 pounds
  • ECOG ≤ 2
  • Repeat biopsy feasible
  • No clinically significant autoimmune disease

Exclusion Criteria:

  • Patients with known metastatic disease
  • Prior systemic treatment for esophagus, GEJ, or the stomach adenocarcinoma
  • Patients with uncontrolled autoimmune disease per investigator discretion
  • Inability or refusal to undergo biopsy procedures to obtain tissue samples

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tremelimumab and Durvalumab

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

Interventions

Tremelimumab

single dose, 300mg IV, day 1

Durvalumab

single dose, 1500 mg IV, day 1

Primary outcome measure

  • Percentage of Subjects Completing Study Treatment [ Time Frame: 2 Years ]
  • Percentage of Subjects Completing Post-Treatment Biopsy [ Time Frame: 2 Years ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Farshid Dayyani, MD, PhD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Jul 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-07-07.