ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu

University of California Irvine (UCI)

Status and phase: Begins enrollment in 1 month; Early Phase 1

Conditions: Solid Tumor, Adult; Malignant Solid Tumor; Esophageal Adenocarcinoma; Stomach Adenocarcinoma

Treatments: Drug: Durvalumab; Drug: Tremelimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06824363

6069

UCI 23-173 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Tremelimumab and Durvalumab

Experimental group

Description:

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

Treatment:

Drug: Tremelimumab

Drug: Durvalumab