SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)

Sponsor
Queensland Centre for Gynaecological Cancer
Study ID
NCT06278857
Phase
PHASE2
Status
Recruiting
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Conditions

  • Endometrial Cancer Stage I
  • Endometrioid Endometrial Adenocarcinoma
  • Immune-related Adverse Event
  • Mmr Deficiency

Eligibility Criteria

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

Interventions

Study Details

The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions. Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks. This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.

Key Dates

Start date
Aug 1, 2024
Status verified
Dec 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Single Arm
    Participation involves seven dostarlimab sessions over 12 months, with a treatment protocol of four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.

Primary Outcome Measure

Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab. [ Time Frame: Week 27 (Month 6) ]

Central Contacts

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