A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer

Phase 2Active Not RecruitingNCT06317311

GlaxoSmithKline41 enrolled

Overview

The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma

Interventions

DostarlimabBIOLOGICAL

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)

CarboplatinDRUG

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)

PaclitaxelDRUG

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)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Chiba, Japan

Outcomes

Primary Outcomes

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

DRR12 is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) lasting greater than or equal to (≥) 12 months, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Time frame: Approximately 18 months

Secondary Outcomes

DRR12 per RECIST 1.1, assessed by investigator

Time frame: Approximately 18 months

Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator

PFS is defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause

Time frame: Up to approximately 3 years

Overall survival (OS)

OS is defined as time from first dose of study intervention to death from any cause

Time frame: Up to approximately 3 years

Overall response rate (ORR) per RECIST 1.1 assessed by BICR

ORR is achieving a best overall response (BOR) of CR or PR. BOR is defined as the best confirmed response \[CR \> PR \> Stable disease (SD) \> Progressive Disease (PD) \> Not evaluable (NE)\] from treatment start date until disease progression, death or initiation of next line of therapy, whichever is earlier

Time frame: Up to approximately 3 years

ORR per RECIST 1.1 assessed by investigator

Time frame: Up to approximately 3 years

Disease control rate (DCR) per RECIST 1.1 assessed by BICR

Achieving a BOR of CR, PR, or SD, defined as the best confirmed response (CR \> PR \> SD) from treatment start date until disease progression, death or initiation of next line of therapy, whichever is earlier

Data from ClinicalTrials.gov

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