Klinische Studie

A Phase 3 Randomized, Open-Label, Trial of Pembrolizumab Plus Lenvatinib Versus Chemotherapy for the First-line Treatment of Persistent, Recurrent or Metastatic Endometrial Carcinoma MSD MK 7902-001(MSD MK 7902-001)A Phase 3 Randomized, Open Study of Pembrolizumab Plus Lenvatinib vs Chemoth. for First-line Treatment of Adv./ Recurrent Endometrial Carcinoma
EUDRACT2018-003009-24
NCT-
DRKS-
Krankheitsentität(en) Weibliches Genital (z.B. Eierstock, Eileiter, Gebärmutter, Scheide, Schamlippen)
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien• Have Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or non-measurable but radiographically apparent, per RECIST 1.1 as assessed by BICR. Notes about prior therapy:  May have received prior chemotherapy only if administered concurrently with radiation  May have received prior radiation  May have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued ≥1 week prior to randomization • Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determination of MMR status. • Have an ECOG performance status of 0 or 1, as assessed within 7 days prior to the first dose of study intervention. • Be female and at least 18 years of age on the day of signing consent. • Not be pregnant of breastfeeding, and at least one of the following conditions applies:  Not be a woman of child-bearing potential (WOCBP, as defined by Sponsor) or  A WOCPB must follow Sponsor’s contraceptive guidance • The participant (or legally acceptable representative if applicable) provides written informed consent for the study. • Have adequately controlled BP with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week prior to randomization. • Have adequate organ function (parameters provided by Sponsor) within 7 days prior to the first dose of study intervention
Wesentliche Ausschlusskriterien• Has carcinosarcoma (malignant mixed Műllerian tumor), endometrial leiomyosarcoma or other high grade sarcomas, or endometrial stromal sarcomas. • Participants with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or 7 symptoms of CNS metastases must be stable for at least 4 weeks before starting study treatment. • Has a known additional malignancy (other than endometrial carcinoma) that is progressing or has required active treatment in the last 3 years.  Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, ductal carcinoma in situ, cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded • Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib. • Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
StatusStudie beendet
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823401fhk-studienzentrum(at)csj.de
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