ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- Tremelimumab
- Durvalumab
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov