Neoplasms, EndometrialPhase 4NCT06897527
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)
A Phase 4 study testing Dostarlimab in people with Neoplasms, Endometrial, run by GlaxoSmithKline.
Trial summary
The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasms, Endometrial
- What is being tested?
- Dostarlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 13 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants ≥18 years of age, at the time of signing the informed consent.
- Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinum containing regimen.
- Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
- WOCBP (Women of childbearing potential) agree to use contraceptive from screening through at least 120 days after the last dose.
- Negative serum or urine pregnancy test at most 72 hours prior to the first dose of study medication.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, in accordance with applicable laws.
Who cannot join
- Known active hepatic disease, End-Stage Renal Disease (ESRD) or known case of serious, uncontrolled medical disorder/active infections which precludes participant's inclusion in the study as per the investigator's judgement.
- Either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class of the study drug.
- Received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1) agent.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Received a live vaccine within 14 days of planned start of study therapy.
- Participation in another clinical study with a study drug administered in the last 3 months.
- Pregnant, breastfeeding, or expecting to conceive while receiving study treatment and for up to 120 days after the last dose of study treatment.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 4, Open Label, Non-comparative, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Mismatch Repair Deficient (dMMR)/Microsatellite Instability-high (MSI-H) Recurrent or Advanced Endometrial Cancer (EC) That Has Progressed on or Following Prior Treatment With a Platinum-containing Regimen
The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
- Conditions
- Neoplasms, Endometrial
- Being tested
- Dostarlimab
- Keywords
- Dostarlimab, Endometrial cancer, dMMR, MSI-H
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
Dostarlimab will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab | Experimental | Not described Receives: Drug: Dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 25 weeks
Secondary outcomes (18)
Number of Participants with any TEAEs
Measured: Up to 25 weeks
Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, treatment related fatal AEs, non-fatal SAEs
Measured: Up to 25 weeks
Number of Participants with AEs leading to discontinuation of treatment, AEs leading to death, AEs leading to study withdrawal and AEs leading to dose modification
Measured: Up to 25 weeks
Change from baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Blood urea nitrogen [BUN], glucose, calcium, sodium, and potassium levels (Millimoles per Liter)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Total protein levels (Gram per liter)
Measured: Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter)
Measured: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg])
Measured: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: pulse rate (Beats per minute)
Measured: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: body temperature (Degrees Celsius)
Measured: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: respiratory rate (breaths per minute)
Measured: Baseline (Day 1) up to 25 weeks
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute)
Measured: Baseline (Day 1) up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start15 Jul 2025 (estimated)
- Primary completion13 Jan 2027 (estimated)
- Study completion13 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, EndometrialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897527
- Sponsor's protocol ID
- 221460
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Open Label, Non-comparative, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Mismatch Repair Deficient (dMMR)/Microsatellite Instability-high (MSI-H) Recurrent or Advanced Endometrial Cancer (EC) That Has Progressed on or Following Prior Treatment With a Platinum-containing Regimen
- ClinicalTrials.gov ID
- NCT06897527
- Acronym / sponsor ID
- 221460
- Conditions
- Neoplasms, Endometrial
- Keywords
- Dostarlimab, Endometrial cancer, dMMR, MSI-H
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 13 Jan 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab | Experimental | Drug: Dostarlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants ≥18 years of age, at the time of signing the informed consent.
- Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinum containing regimen.
- Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
- WOCBP (Women of childbearing potential) agree to use contraceptive from screening through at least 120 days after the last dose.
- Negative serum or urine pregnancy test at most 72 hours prior to the first dose of study medication.
Key exclusion criteria (8 listed)
- Known active hepatic disease, End-Stage Renal Disease (ESRD) or known case of serious, uncontrolled medical disorder/active infections which precludes participant's inclusion in the study as per the investigator's judgement.
- Either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class of the study drug.
- Received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1) agent.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Received a live vaccine within 14 days of planned start of study therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabDostarlimab will be administered. | Drug | Dostarlimab |
Primary outcome
Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 25 weeks
18 secondary outcomes
Number of Participants with any TEAEs
Time frame: Up to 25 weeks
Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, treatment related fatal AEs, non-fatal SAEs
Time frame: Up to 25 weeks
Number of Participants with AEs leading to discontinuation of treatment, AEs leading to death, AEs leading to study withdrawal and AEs leading to dose modification
Time frame: Up to 25 weeks
Change from baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Blood urea nitrogen [BUN], glucose, calcium, sodium, and potassium levels (Millimoles per Liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Total protein levels (Gram per liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter)
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg])
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: pulse rate (Beats per minute)
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: body temperature (Degrees Celsius)
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in Vital signs: respiratory rate (breaths per minute)
Time frame: Baseline (Day 1) up to 25 weeks
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute)
Time frame: Baseline (Day 1) up to 25 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dostarlimab in people with Neoplasms, Endometrial, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.