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

ConditionsSolid Tumor, AdultMalignant Solid TumorStomach AdenocarcinomaEsophageal Adenocarcinoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Tremelimumab

    Drug

    single dose, 300mg IV, day 1

  • Durvalumab

    Drug

    single dose, 1500 mg IV, day 1

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Tremelimumab and DurvalumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Subjects Completing Study Treatment

Percentage of Subjects Completing the Study Treatment

Time frame
2 Years
2

Percentage of Subjects Completing Post-Treatment Biopsy

Percentage of Subjects Completing the Post-Treatment Biopsy

Time frame
2 Years

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov
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