Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05379972
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200mg IV every 3 weeks starting C2D1
  • Olaparib — DRUG
    Olaparib 200mg orally twice daily starting C1D1 concurrently with radiation. Starting C2D1, Olaparib 300mg orally twice with Pembrolizumab
  • Stereotactic Body Radiation Therapy — RADIATION
    Stereotactic Body Radiation Therapy Dose 25Gy in 5 fractions daily (M-F) for 5 days starting C1D1 with Olaparib

Study Details

This study is an open-label, phase II study with a safety lead-in to assess the response rate of induction olaparib and stereotactic beam radiotherapy (SBRT) followed by combination olaparib/pembrolizumab in patients with metastatic gastric and GEJ cancers after at least one of therapy.

Key Dates

Start date
Jan 12, 2023
Status verified
May 2026
Primary completion
Feb 24, 2025
Completion
Jan 22, 2026

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HR deficient cohort
    Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.
  • Experimental: HR proficient cohort
    No identifiable somatic or germline deleterious mutation in DNA Response and Repair pathway

Primary Outcome Measure

Objective Response Rate (ORR) of Unirradiated Tumors [ Time Frame: 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Colorado HealthAuroraColorado80045-
UCHealth Memorial Hospital CentralColorado SpringColorado80909-
UCHealth Memorial Hospital NorthColorado SpringsColorado80909-
UCHealth Highlands Ranch HospitalHighlands RanchColorado80129-

Related coverage on Hipa.ai

Find similar trials in Aurora, CO

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
University of Colorado Health· Aurora, COUCHealth Memorial Hospital Central· Colorado Spring, COUCHealth Memorial Hospital North· Colorado Springs, COUCHealth Highlands Ranch Hospital· Highlands Ranch, CO

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