- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07652515
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer
torstai 11. kesäkuuta 2026 päivittänyt: GlaxoSmithKline
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).
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
100
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: US GSK Clinical Trials Call Center
- Puhelinnumero: 877-379-3718
- Sähköposti: GSKClinicalSupportHD@gsk.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: EU GSK Clinical Trials Call Center
- Puhelinnumero: +44 (0) 20 89904466
- Sähköposti: GSKClinicalSupportHD@gsk.com
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy
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.
|
Dostarlimabia annetaan.
Karboplatiinia annetaan.
Paklitakselia annetaan.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49
Aikaikkuna: Up to Week 49
|
Up to Week 49
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Number of participants with Grade 3 or greater TEAEs up to Week 170
Aikaikkuna: Up to Week 170
|
Up to Week 170
|
|
Number of participants with TEAEs up to Week 49
Aikaikkuna: Up to Week 49
|
Up to Week 49
|
|
Number of participants with TEAEs up to Week 170
Aikaikkuna: Up to Week 170
|
Up to Week 170
|
|
Number of participants with Immune-related adverse events (irAEs) up to Week 49
Aikaikkuna: Up to Week 49
|
Up to Week 49
|
|
Number of participants with Immune-related adverse events (irAEs) up to Week 170
Aikaikkuna: Up to Week 170
|
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
Aikaikkuna: Up to Week 49
|
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
Aikaikkuna: Up to Week 170
|
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
Aikaikkuna: Up to Week 49
|
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
Aikaikkuna: Up to Week 170
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 49
Aikaikkuna: Baseline (Day 1) and up to 49
|
Baseline (Day 1) and up to 49
|
|
Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 170
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 49
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 170
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) up to Week 49
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) to up to Week 170
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 49
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 170
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
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
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 49
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 170
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 49
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 170
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 49
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 170
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
|
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 49
Aikaikkuna: Baseline (Day 1) and up to Week 49
|
Baseline (Day 1) and up to Week 49
|
|
Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 170
Aikaikkuna: Baseline (Day 1) and up to Week 170
|
Baseline (Day 1) and up to Week 170
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: GSK Clinical Trials, GlaxoSmithKline
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Maanantai 17. elokuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Perjantai 30. elokuuta 2030
Opintojen valmistuminen (Arvioitu)
Perjantai 30. elokuuta 2030
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 11. kesäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 11. kesäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 17. kesäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 17. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 11. kesäkuuta 2026
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Urogenitaaliset kasvaimet
- Neoplasmat sivustoittain
- Neoplasmat
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Kohdun sairaudet
- Sukuelinten sairaudet, naiset
- Sukuelinten kasvaimet, naiset
- Kohdun kasvaimet
- Endometriumin kasvaimet
- Orgaaniset kemikaalit
- Hiilivety
- Sykloparaffiinit
- Hiilivedyt, aliisykliset
- Hiilivedyt, sykliset
- Terpeenit
- Koordinointikompleksit
- Taksoidit
- Syklodekaanit
- Diterpeenit
- Karboplatiini
- Paklitakseli
- dostarlimab
Muut tutkimustunnusnumerot
- 309169
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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
IPD-jaon aikakehys
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.
IPD-jaon käyttöoikeuskriteerit
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.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Joo
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .