A Study to Investigate GSK5733584 as Maintenance Treatment for Participants With MMRp Endometrial Cancer (BEHOLD-Endometrial02)

Sponsor
GlaxoSmithKline
Study ID
NCT07684599
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Neoplasms, Endometrial

Eligibility Criteria

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

Interventions

  • GSK5733584 — DRUG
    GSK5733584 will be administered
  • Dostarlimab — DRUG
    Dostarlimab will be administered
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered

Study Details

The purpose of this study is to see how well GSK5733584 in combination with standard treatment of choice works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared to current standard of care. The study will also assess whether drug combination is safe and tolerated well by participants compared to the usual care and will help us better understand its impact on Health-Related Quality of Life of participants.

Key Dates

First listed
Jul 6, 2026
Start date
Sep 3, 2026
Status verified
Jul 2026
Primary completion
Jul 23, 2029
Completion
Sep 18, 2031

Study Design

Enrollment
610 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GSK5733584 plus Standard of Care (SOC)
    Participants will receive GSK5733584 along with SOC (Dostarlimab or Pembrolizumab)
  • Active Comparator: Standard of Care
    Participants will receive standard of care (Dostarlimab or Pembrolizumab) as per investigator's discretion

Primary Outcome Measure

Progression free survival (PFS) by BICR assessment [ Time Frame: Up to approximately 151 weeks ]

Central Contacts