A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer

NCT07652515 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 309169
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Neoplasms, Endometrial

Keywords

Carboplatin; Dostarlimab; Endometrial cancer; First line treatment; Paclitaxel

Outcome Measures

Primary Outcomes (1)

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

  Up to Week 49

Secondary Outcomes (39)

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

  Up to Week 170

• Number of participants with TEAEs up to Week 49

  Up to Week 49

• Number of participants with TEAEs up to Week 170

  Up to Week 170

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

  Up to Week 49

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

  Up to Week 170

Study Arms (1)

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.

Drug: Dostarlimab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Dostarlimab DRUG

Dostarlimab will be administered.

Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy

Carboplatin DRUG

Carboplatin will be administered.

Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy

Paclitaxel DRUG

Paclitaxel will be administered.

Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adult Indian female participants diagnosed with EC who are eligible to receive first-line systemic therapy for primary advanced or recurrent disease will be enrolled.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

dostarlimab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.