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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) (RUBY-J)

A study of dostarlimab in combination with carboplatin-paclitaxel in Japanese participants with primary advanced or recurrent endometrial cancer (RUBY-J)

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Not Recruiting

May. 07, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Female

Endometrial Cancer

-Dostarlimab is administered via intravenous (IV) infusion at a dose of 500 milligram (mg) for first 6 cycles (each cycle is of 21 days) followed by 1,000 mg from cycle 7 (each cycle is of 42 days).
-Carboplatin is administered IV at a dose of Area under the concentration time curve (AUC) 5 milligram*millilitre/ minute (mg mL/min) for cycles 1 to 6 (each cycle is of 21 days).
-Paclitaxel is administered IV at a dose of 175 milligram per meter square (mg/m2) for cycles 1 to 6 (each cycle is of 21 days).

Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR)

-DRR12 per RECIST 1.1, assessed by investigator
-Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator
-OS is defined as time from first dose of study intervention to death from any cause
-Overall response rate (ORR) per RECIST 1.1 assessed by investigator and BICR
-Disease control rate (DCR) per RECIST 1.1 assessed by investigator and BICR
-Duration of response (DOR) per RECIST 1.1 assessed by investigator and BICR
-Maximum concentration (Cmax) and Minimum concentration (Cmin) for dostarlimab
-Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity
-Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation
-Number of participants with AEs leading to death

+81-86-235-7534

Mar. 21, 2024

Yes

[Plan Description] IPD for this study will be made available via the Clinical Study Data Request site. [URL] http://clinicalstudydatarequest.com

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