Clinical trial · Interventional
ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
| Stomach Adenocarcinoma | Gastric Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tremelimumab and Durvalumab
- description
- Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1
- interventionNames
- Drug: Tremelimumab
- Drug: Durvalumab
Primary outcomes (2)
- measure
- Percentage of Subjects Completing Study Treatment
- timeFrame
- 2 Years
- description
- Percentage of Subjects Completing the Study Treatment
- measure
- Percentage of Subjects Completing Post-Treatment Biopsy
- timeFrame
- 2 Years
- description
- Percentage of Subjects Completing the Post-Treatment Biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available