Neoplasms, EndometrialPhase 4NCT07652515
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer
A Phase 4 study testing Dostarlimab, Carboplatin and Paclitaxel in people with Neoplasms, Endometrial, run by GlaxoSmithKline.
Trial summary
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). 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, Carboplatin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2026to 30 Aug 2030
- 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
- 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 must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination based on investigator's assessment.
- Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
- Woman of childbearing potential (WOCBP) agrees to use contraceptive from screening through at least 180 days after the last dose.
- Negative urine pregnancy test at most 24 hours prior to the first dose of study intervention.
- Capable of giving signed informed consent.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- 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.
- Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
- Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.
- Participant has not recovered (i.e., to Grade less than or equal to [<=] 1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony-stimulating factor [G-CSF], Granulocyte macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within 21 days prior to the first dose of study drug.
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- Either the history of hypersensitivity to excipients of the study intervention or to drugs with a similar chemical structure or class of the study intervention.
- Participant has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative] is detected).
- Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:
- has not had a recurrence or Progressive disease (PD) prior to first dose on the study, or
- has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study.
- Participant has received prior therapy with an anti- Programmed death protein 1 (anti-PD-1), anti- Programmed death ligand 1 (anti-PD-L1), or Programmed death ligand 2 (anti PD L2) agent.
- Participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days or <5 times the half life of the most recent therapy prior to study Day 1, whichever is shorter.
- Systemic glucocorticoids for any purpose other than to manage symptoms of suspected irAEs. If medically deemed necessary (e.g., acute asthma or chronic obstructive pulmonary disease exacerbation, prophylaxis for intravenous (IV) contrast if indicated), Investigators are allowed to use their judgment to treat participants with systemic steroids. In such cases, systemic steroids should be stopped at least 24 hours prior to the next dose of study treatment.
- Participant has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study intervention, during study treatment, and for up to 180 days after receiving the last dose of study intervention.
- Participant has a diagnosis of immunodeficiency and is receiving systemic steroid therapy (>10 milligrams [mg] daily prednisone or equivalent) within 7 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication.
- Participant is currently receiving study intervention, or is enrolled or has participated in any other clinical study involving an investigational intervention and received investigational treatment or used an investigational device within 4 weeks of the first dose of dostarlimab.
- Participant is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study intervention.
- Judgment by the investigator that the participant should not participate in the study if the participant 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, Single-arm, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Primary Advanced or Recurrent Endometrial Cancer
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).
- Conditions
- Neoplasms, Endometrial
- Being tested
- Dostarlimab, Carboplatin, Paclitaxel
- Keywords
- Carboplatin, Dostarlimab, Endometrial cancer, First line treatment, Paclitaxel
- 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.
CarboplatinDrug
Carboplatin will be administered.
PaclitaxelDrug
Paclitaxel will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy | Experimental | Participants will receive dose level 1 of dostarlimab in combination with carboplatin and paclitaxel followed by dose level 2 of dostarlimab monotherapy. Dose level 1 is the lowest dose level. Receives: Drug: Dostarlimab; Drug: Carboplatin; Drug: Paclitaxel |
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) up to Week 49
Measured: Up to Week 49
Secondary outcomes (39)
Number of participants with Grade 3 or greater TEAEs up to Week 170
Measured: Up to Week 170
Number of participants with TEAEs up to Week 49
Measured: Up to Week 49
Number of participants with TEAEs up to Week 170
Measured: Up to Week 170
Number of participants with Immune-related adverse events (irAEs) up to Week 49
Measured: Up to Week 49
Number of participants with Immune-related adverse events (irAEs) up to Week 170
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (Day 1) and up to Week 170
Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 49
Measured: Baseline (Day 1) and up to 49
Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 170
Measured: Baseline (Day 1) and up to Week 170
Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 49
Measured: Baseline (Day 1) and up to Week 49
Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 170
Measured: Baseline (Day 1) and up to Week 170
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) up to Week 49
Measured: Baseline (Day 1) and up to Week 49
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) to up to Week 170
Measured: Baseline (Day 1) and up to Week 170
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 49
Measured: Baseline (Day 1) and up to Week 49
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 170
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (Day 1) and up to Week 170
Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 49
Measured: Baseline (Day 1) and up to Week 49
Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 170
Measured: Baseline (Day 1) and up to Week 170
Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 49
Measured: Baseline (Day 1) and up to Week 49
Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 170
Measured: Baseline (Day 1) and up to Week 170
Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 49
Measured: Baseline (Day 1) and up to Week 49
Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 170
Measured: Baseline (Day 1) and up to Week 170
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 49
Measured: Baseline (Day 1) and up to Week 49
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 170
Measured: Baseline (Day 1) and up to Week 170
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start17 Aug 2026 (estimated)
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Aug 2030 (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
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652515
- Sponsor's protocol ID
- 309169
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07652515
- Acronym / sponsor ID
- 309169
- Conditions
- Neoplasms, Endometrial
- Keywords
- Carboplatin, Dostarlimab, Endometrial cancer, First line treatment, Paclitaxel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 17 Jun 2026 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy | Experimental | Drug: Dostarlimab, Drug: Carboplatin, Drug: PaclitaxelParticipants will receive dose level 1 of dostarlimab in combination with carboplatin and paclitaxel followed by dose level 2 of dostarlimab monotherapy. Dose level 1 is the lowest dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination based on investigator's assessment.
- Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
- Woman of childbearing potential (WOCBP) agrees to use contraceptive from screening through at least 180 days after the last dose.
Key exclusion criteria (19 listed)
- 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.
- Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
- Participant has not recovered adequately from AEs or complications from any major surgery prior to starting 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 | Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy |
| CarboplatinCarboplatin will be administered. | Drug | Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy |
| PaclitaxelPaclitaxel will be administered. | Drug | Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy |
Primary outcome
Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49
Time frame: Up to Week 49
39 secondary outcomes
Number of participants with Grade 3 or greater TEAEs up to Week 170
Time frame: Up to Week 170
Number of participants with TEAEs up to Week 49
Time frame: Up to Week 49
Number of participants with TEAEs up to Week 170
Time frame: Up to Week 170
Number of participants with Immune-related adverse events (irAEs) up to Week 49
Time frame: Up to Week 49
Number of participants with Immune-related adverse events (irAEs) up to Week 170
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 1) and up to Week 170
Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 49
Time frame: Baseline (Day 1) and up to 49
Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 170
Time frame: Baseline (Day 1) and up to Week 170
Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 49
Time frame: Baseline (Day 1) and up to Week 49
Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 170
Time frame: Baseline (Day 1) and up to Week 170
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) up to Week 49
Time frame: Baseline (Day 1) and up to Week 49
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) to up to Week 170
Time frame: Baseline (Day 1) and up to Week 170
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 49
Time frame: Baseline (Day 1) and up to Week 49
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 170
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 1) and up to Week 170
Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 49
Time frame: Baseline (Day 1) and up to Week 49
Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 170
Time frame: Baseline (Day 1) and up to Week 170
Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 49
Time frame: Baseline (Day 1) and up to Week 49
Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 170
Time frame: Baseline (Day 1) and up to Week 170
Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 49
Time frame: Baseline (Day 1) and up to Week 49
Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 170
Time frame: Baseline (Day 1) and up to Week 170
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 49
Time frame: Baseline (Day 1) and up to Week 49
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 170
Time frame: Baseline (Day 1) and up to Week 170
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 17 Jun 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dostarlimab, Carboplatin and Paclitaxel 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 8 inclusion and 19 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 17 Jun 2026. 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) up to Week 49 (time frame: Up to Week 49). 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 17 Jun 2026.