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

NCT06278857 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-03

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]

The dosing regimen follows standard clinical care protocol comprising of 4 cycles every 3-weeks, a rest period of 34 weeks followed by 3 cycles every 6 weekly for a total of 7 cycles.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Queensland Centre for Gynaecological Cancer

    lead OTHER_GOV

Principal Investigators

  • Andreas Obermair, Professor · Queensland Centre for Gynaecological Cancer (QCGC) Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06278857 on ClinicalTrials.gov