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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06317311
Other study ID # 221968
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 7, 2024
Est. completion date August 31, 2027

Study information

Verified date May 2024
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date August 31, 2027
Est. primary completion date July 15, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Dostarlimab
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)
Drug:
Carboplatin
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
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)

Locations

Country Name City State
Japan GSK Investigational Site Aichi
Japan GSK Investigational Site Chiba
Japan GSK Investigational Site Ehime
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Gunma
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Hyogo
Japan GSK Investigational Site Ibaraki
Japan GSK Investigational Site Iwate
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Okayama
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Saitama
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tochigi
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Approximately 18 months
Secondary DRR12 per RECIST 1.1, assessed by investigator Approximately 18 months
Secondary 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 Up to approximately 3 years
Secondary Overall survival (OS) OS is defined as time from first dose of study intervention to death from any cause Up to approximately 3 years
Secondary 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 Up to approximately 3 years
Secondary ORR per RECIST 1.1 assessed by investigator Up to approximately 3 years
Secondary 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 Up to approximately 3 years
Secondary DCR per RECIST 1.1 assessed by investigator Up to approximately 3 years
Secondary Duration of response (DOR) per RECIST 1.1 assessed by BICR DOR is defined as the time from the date of first documented objective response to the date of first documented PD or death, whichever comes first Up to approximately 3 years
Secondary DOR per RECIST 1.1 assessed by investigator Up to approximately 3 years
Secondary Maximum concentration (Cmax) for dostarlimab Up to 67 weeks
Secondary Minimum concentration (Cmin) for dostarlimab Up to 67 weeks
Secondary Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity Up to approximately 3 years
Secondary Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation Up to approximately 3 years
Secondary Number of participants with AEs leading to death Up to approximately 3 years
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