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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06824363
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Esophageal Adenocarcinoma
  • Malignant Solid Tumor
  • Solid Tumor, Adult
  • Stomach Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Feb 13, 2025
Start date
May 25, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tremelimumab and Durvalumab
    Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1

Primary Outcome Measure

Percentage of Subjects Completing Study Treatment [ Time Frame: 2 Years ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Farshid Dayyani, MD, PhD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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