An Early Phase 1 interventional study of Tremelimumab and Durvalumab in Solid Tumor, Adult, Malignant Solid Tumor and Stomach Adenocarcinoma, sponsored by University of California, Irvine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by University of California, Irvine · Early Phase 1, Interventional, and Treatment
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.
116 studies on the registry are indexed under Adenocarcinoma Of Esophagus; 72 are open to participants now.
This study's planned enrollment of 34 is below the median of 78 across 101 interventional studies indexed under Adenocarcinoma Of Esophagus.
Browse Adenocarcinoma Of Esophagus studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1
Drug: Tremelimumab · Drug: Durvalumab
single dose, 300mg IV, day 1
single dose, 1500 mg IV, day 1
Percentage of Subjects Completing Study Treatment
Percentage of Subjects Completing the Study Treatment
Time frame: 2 Years
Percentage of Subjects Completing Post-Treatment Biopsy
Percentage of Subjects Completing the Post-Treatment Biopsy
Time frame: 2 Years
Percent Change in the Proportion of Intra Tumoral Effector T-cells
Assessment of Effects on Tumor Microenvironment Composition based on the percent change in the proportion of intra tumoral effector T-cells (CD3/CD8) at 2-6 weeks post single dose of STRIDE regiment compared to that at baseline
Time frame: 2 years
Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay.
Assessment of effects on circulating cytokine from whole blood collection at baseline and after receiving Tremelimumab and Durvalumab. Blood samples will be used to perform a 96-cytokine-discovery assay. https://www.evetechnologies.com/product/new-human-cytokine-chemokine-96-plex-discovery-assay-array-hd96/
Time frame: 2 years
Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events
Evaluation of safety and adverse events of patients who received one dose of Tremelimumab and Durvalumab using the CTCAE version 5.0
Time frame: 2 years
Comparison of T-Cell Infiltration in Various Tumor Mutations
Comparison of T-Cell Infiltration in ARID1A mutated tomors to ARID1A wile-type tumors.
Time frame: 2 years
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University of California, Irvine