Esophageal Adenocarcinoma, Malignant Solid Tumor, Solid Tumor, Adult, Stomach Adenocarcinoma
Conditions
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.
Interventions
DRUGTremelimumab
single dose, 300mg IV, day 1
DRUGDurvalumab
single dose, 1500 mg IV, day 1
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Completing Study Treatment | 2 Years | Percentage of Subjects Completing the Study Treatment |
| Percentage of Subjects Completing Post-Treatment Biopsy | 2 Years | Percentage of Subjects Completing the Post-Treatment Biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in the Proportion of Intra Tumoral Effector T-cells | 2 years | 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 |
| Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay. | 2 years | 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/ |
| Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events | 2 years | Evaluation of safety and adverse events of patients who received one dose of Tremelimumab and Durvalumab using the CTCAE version 5.0 |
| Comparison of T-Cell Infiltration in Various Tumor Mutations | 2 years | Comparison of T-Cell Infiltration in ARID1A mutated tomors to ARID1A wile-type tumors. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORFarshid Dayyani
Chao Family Comprehensive Cancer Center
Outcome results
None listed