Not yet recruiting NCT06897527
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dostarlimab.
- Who it may be relevant to
- Registry conditions: Neoplasms, Endometrial. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
Interventions
- Drug Dostarlimab
Dostarlimab will be administered.
Primary outcome measures
- Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 25 weeks]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06897527 · 221460