Combining dostarlimab with carboplatin and paclitaxel for advanced endometrial cancer in Japanese patients

A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Japanese Patients With Primary Advanced or Recurrent Endometrial Cancer (RUBY-J)

This study is testing if a new combination of drugs can help Japanese patients with advanced or recurring endometrial cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, dostarlimab
• Locations: 20 sites (Aichi and 19 other locations)
• Trial ID: NCT06317311 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of dostarlimab in combination with carboplatin and paclitaxel in patients with primary advanced or recurrent endometrial cancer. Participants will receive the combination treatment followed by dostarlimab monotherapy. The study focuses on patients with specific molecular subtypes of endometrial cancer, assessing their response to the treatment regimen. The trial is designed to provide insights into the potential benefits of this combination therapy for improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include Japanese participants with recurrent or advanced endometrial cancer who have specific molecular subtypes and measurable lesions.

Not a fit: Patients with early-stage endometrial cancer or those who do not meet the molecular subtype criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could offer a new effective option for patients with advanced endometrial cancer.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating endometrial cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
2. Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
3. Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one measurable lesion per RECIST 1.1 based on Investigator's assessment.
4. Participant is not pregnant or breastfeeding and agrees to use a highly effective contraceptive method during the study period if a woman of childbearing potential (WOCBP).
5. Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1.
6. Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters.

Exclusion Criteria:

1. Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
2. Participant has any medical history of interstitial lung disease or pneumonitis.
3. Participant has cirrhosis or current unstable liver or biliary disease.
4. Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
5. Participant has a diagnosis of immunodeficiency.
6. Participant has received prior therapy with an anti- Programmed death protein 1 (PD-1), anti- Programmed death ligand 1 (PD-L1), anti- Programmed death ligand 2 (PD-L2), or anti- Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.
7. Participant has not recovered adequately from AEs.
8. Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or \<5 times the half-life of the most recent therapy prior to the first dose of study intervention, whichever is shorter.
9. Participant has received any live vaccine within 30 days of the first dose of study intervention. Vaccination against coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms are not exclusionary.
10. Participant has HBsAg positive, or HCV RNA positive.
11. Participant is known HIV infection.
12. Participant is currently participating and receiving study intervention or has participated in a study of an investigational agent and received study intervention or used an investigational device within 4 weeks of the first dose of treatment.
13. Participant with contraindication to carboplatin and paclitaxel.

Where this trial is running

Aichi and 19 other locations

• GSK Investigational Site — Aichi, Japan (Recruiting)
• GSK Investigational Site — Chiba, Japan (Recruiting)
• GSK Investigational Site — Ehime, Japan (Recruiting)
• GSK Investigational Site — Fukuoka, Japan (Recruiting)
• GSK Investigational Site — Fukuoka, Japan (Recruiting)
• GSK Investigational Site — Gunma, Japan (Recruiting)
• GSK Investigational Site — Hokkaido, Japan (Recruiting)
• GSK Investigational Site — Hyogo, Japan (Recruiting)
• GSK Investigational Site — Ibaraki, Japan (Recruiting)
• GSK Investigational Site — Iwate, Japan (Recruiting)
• GSK Investigational Site — Kanagawa, Japan (Recruiting)
• GSK Investigational Site — Okayama, Japan (Recruiting)
• GSK Investigational Site — Osaka, Japan (Recruiting)
• GSK Investigational Site — Osaka, Japan (Recruiting)
• GSK Investigational Site — Saitama, Japan (Recruiting)
• GSK Investigational Site — Shizuoka, Japan (Recruiting)
• GSK Investigational Site — Tochigi, Japan (Recruiting)
• GSK Investigational Site — Tokyo, Japan (Recruiting)
• GSK Investigational Site — Tokyo, Japan (Recruiting)
• GSK Investigational Site — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Carcinoma; Endometrial cancer; Dostarlimab; Carboplatin; Paclitaxel