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

Carcinoma Clinical Trial

— RUBY-J  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317311
• Other study ID #: 221968
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 16, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: March 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• 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: Not yet 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.

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Neoplasms

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