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

Immune-related Adverse Event Clinical Trial

Official title: A Phase 2b, Open-label, Single Arm, Multicentre, Pilot Study of the Efficacy, Safety and Tolerability of Dostarlimab in Women With Early-stage MMR Deficient Endometrioid Endometrial Adenocarcinoma.

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Cancer of the endometrium is a common type of cancer that affects over 3,000 women in Australia every year. The usual way to treat this cancer is by having surgery to remove the uterus, fallopian tubes, ovaries, and sometimes lymph nodes. But this surgery might not be the best choice for women who want to have children or for older women, those with obesity, or people with other health problems, because surgery can be risky for them.

Big improvements in the treatment of endometrial cancer have occurred due to new technology and enhanced understanding of this cancer. In the past, doctors decided how to treat this cancer based on what it looked like and how likely it was to come back. But in recent years, they've been looking at the genes of the cancer to figure out the best treatment for each person. This is important to make sure each patient gets the right care.

The research project evaluates 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. DNA repair errors can lead to cancer, and the Mismatch Repair (MMR) pathway addresses these errors. dostarlimab enhances the immune system's ability to combat cancer by blocking specific proteins, and while approved in Australia for advanced cases, its effectiveness in early-stage cancer is unknown. 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. The study proposes a unique approach to endometrial cancer treatment.

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.

Dostarlimab is approved in Australia for the treatment of adult patients with recurrent or advanced mismatch repair deficient endometrial cancer. However, it is not currently approved to treat early-stage endometrial cancer. This study will test to see if dostarlimab is an effective treatment for early-stage mismatch repair deficient endometrial cancer. Dostarlimab may be a good option for women who cannot or do not want to have surgery to remove their uterus, fallopian tubes, ovaries and lymph nodes, or who want to keep the option of having children.

This research offers hope for a novel, non-invasive treatment option for patients with specific genetic characteristics, expanding the scope of endometrial cancer care.

Primary objective: To determine the absence of endometrial cancer following protocol treatment regimen of dostarlimab

Secondary objective: To determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma

Exploratory Objective:

• To assess study feasibility

• Assess participant evaluation of study participation providing consumer feedback to inform future clinical research programs.

• To assess longer term (9 and 12 months) changes to laboratory and clinical parameters post treatment with dostarlimab.

• Exploratory investigations utilizing biobanked tissue, blood samples for participant treated with dostarlimab.

• An exploratory outcome of increased clinical efficacy (pCR) related to irAEs.

• Fertility Outcome ;

Related Conditions & MeSH terms

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

• NCT number: NCT06278857
• Study type: Interventional
• Source: Queensland Centre for Gynaecological Cancer
• Contact: Sara Baniahmadi
• Phone: 07 3346 5073
• Email: s.baniahmadi@uq.edu.au
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Completion date: June 30, 2028