Trial Title:
A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
NCT ID:
NCT06317311
Condition:
Carcinoma
Conditions: Official terms:
Endometrial Neoplasms
Paclitaxel
Carboplatin
Dostarlimab
Conditions: Keywords:
Endometrial cancer
Dostarlimab
Carboplatin
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Dostarlimab
Description:
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)
Arm group label:
Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
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)
Arm group label:
Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
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)
Arm group label:
Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy
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
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GSK Investigational Site
Address:
City:
Aichi
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Shiro Suzuki
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Chiba
Zip:
260-8717
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Naotake Tanaka
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Ehime
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Kazuhiro Takehara
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Kazuya Ariyoshi
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Fukuoka
Zip:
830-0011
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Shin Nishio
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Gunma
Zip:
373-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Kazuto Nakamura
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Hokkaido
Zip:
060-8648
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Hidemichi Watari
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Hyogo
Zip:
673-8558
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Satoshi Yamaguchi
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Ibaraki
Zip:
305-8576
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Toyomi Satoh
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Iwate
Zip:
028-3695
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Tsukasa Baba
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Kanagawa
Zip:
259-1193
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Takeshi Hirasawa
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Shoji Nagao
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Osaka
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Tsuyoshi Hisa
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Osaka
Zip:
569-8686
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Satoe Fujiwara
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Saitama
Zip:
350-1298
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Kosei Hasegawa
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Shizuoka
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Yasuyuki Hirashima
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Tochigi
Zip:
329-0498
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Yuji Takei
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Kazuki Sudo
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Mayu Yunokawa
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Tokyo
Zip:
160-8582
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Wataru Yamagami
Email:
Principal Investigator
Start date:
May 7, 2024
Completion date:
August 31, 2027
Lead sponsor:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
GlaxoSmithKline
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06317311