Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UCI 23-173 | Other Identifier | UCI CFCCC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tremelimumab and Durvalumab | Experimental | Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tremelimumab | Drug | single dose, 300mg IV, day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Completing Study Treatment | Percentage of Subjects Completing the Study Treatment | 2 Years |
| Percentage of Subjects Completing Post-Treatment Biopsy | Percentage of Subjects Completing the Post-Treatment Biopsy | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Contact | 1-877-827-8839 | ucstudy@uci.edu | |
| University of California Irvine Medical | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Farshid Dayyani | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine | Recruiting | Orange | California | 92868 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Durvalumab |
| Drug |
single dose, 1500 mg IV, day 1 |
|
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. |
| 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 | 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. | 2 years |
| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C520704 | tremelimumab |
| C000613593 | durvalumab |
Not provided
Not provided
Not provided