Last updated: 06/11/2026 07:10:13

A study to evaluate the safety of dostarlimab in adult participants in India with primary advanced or recurrent endometrial cancer

GSK study ID
309169
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Phase 4, open label, single-arm, interventional, multicenter study to evaluate the safety of dostarlimab in adult patients in India with primary advanced or recurrent endometrial cancer
Trial description: This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).
Primary purpose:
Treatment
Trial design:
Single Group
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49

Timeframe: Up to Week 49

Secondary outcomes:

Number of participants with Grade 3 or greater TEAEs up to Week 170

Timeframe: Up to Week 170

Number of participants with TEAEs up to Week 49

Timeframe: Up to Week 49

Number of participants with TEAEs up to Week 170

Timeframe: Up to Week 170

Number of participants with Immune-related adverse events (irAEs) up to Week 49

Timeframe: Up to Week 49

Number of participants with Immune-related adverse events (irAEs) up to Week 170

Timeframe: Up to Week 170

Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, fatal AEs, non-fatal SAEs up to Week 49

Timeframe: Up to Week 49

Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, fatal AEs, non-fatal SAEs up to Week 170

Timeframe: Up to Week 170

Number of Participants with AEs leading to discontinuation of treatment, AEs leading to study withdrawal and AEs leading to dose modification up to Week 49

Timeframe: Up to Week 49

Number of Participants with AEs leading to discontinuation of treatment, AEs leading to study withdrawal and AEs leading to dose modification up to Week 170

Timeframe: Up to Week 170

Change from Baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 49

Timeframe: Baseline (Day 1) and up to 49

Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) to up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose, calcium, sodium, and potassium levels (Millimoles per Liter) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose, calcium, sodium, and potassium levels (Millimoles per Liter) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in clinical chemistry parameters: Total protein levels (Gram per liter) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in clinical chemistry parameters: Total protein levels (Gram per liter) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 49

Timeframe: Baseline (Day 1) and up to Week 49

Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 170

Timeframe: Baseline (Day 1) and up to Week 170

Interventions:
Drug: Dostarlimab
Drug: Carboplatin
Drug: Paclitaxel
Enrollment:
100
Observational study model:
Not applicable
Primary completion date:
2030-30-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Endometrial
Product
Dostarlimab
Collaborators
Not applicable
Study date(s)
August 2026 to August 2030
Type
Interventional
Phase
4

Participation criteria

Sex
Female
Age
18+ years
Accepts healthy volunteers
No
  • Participant with greater than or equals to (>=) 18 years of age, at the time of signing the informed consent.
  • Participant has histologically or cytologically proven EC with recurrent or advanced disease.
  • Participant has had greater than (>) 1 recurrence of endometrial cancer.
  • Participant has a concomitant malignancy, or participant has a prior non endometrial invasive malignancy who has been disease-free for less than (<) 3 years or who received any active treatment in the last 3 years for that malignancy.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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