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Patients with recurrent or primary advanced endometrial cancer

Tesaro Ruby

a Phase 3, randomized, double-blind, multicenter study of Dostarlimab (TSR-042) plus Carboplatin-Paclitaxel versus Placebo plus Carboplatin-Paclitaxel in patients with recurrent or primary advanced endometrial cancer (Ruby)

Erkrankung: Gebärmutterkrebs u.a. gynäkologische Tumoren Adenokarzinom
Status der Studie: Studie rekrutiert
Studiendesign: interventionell
Studienphase: Phase III
Studienart: Medikamentöse Therapie
Haupteinschlusskritieren: 1. Female subject at least 18 years of age, who is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
2. Subject has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
3. Subject must provide adequate tumor tissue sample at Screening for MSI status testing
Note: The quality of the tumor tissue sample must be confirmed by the central laboratory during screening. Subjects should not be randomized without central laboratory confirmation.
4. Subject must have primary Stage III or Stage IV disease or first recurrent endometrial cancer (see International Federation of Gynecology and Obstetrics staging in Appendix 4) with a low potential for cure by radiation therapy or surgery alone or in combination, and meet at least one of the following criteria:
a. Subject has primary Stage IIIA to IIIC1 disease with presence of evaluable or measurable disease per RECIST v.1.1 based on Investigator’s assessment. Lesions that are equivocal or can be representative of postoperational change should be biopsied and confirmed for the presence of tumor.
b. Subject has primary Stage IIIC1 disease with carcinosarcoma, clear cell, serous, or mixed histology (containing ≥ 10% carcinosarcoma, clear cell, or serous histology) regardless of presence of evaluable or measurable disease on imaging.
c. Subject has primary Stage IIIC2 or Stage IV disease.
d. Subject has first recurrent disease and is chemotherapy naïve.
e. Subject has received prior neo-adjuvant/adjuvant systemic chemotherapy and had a recurrence or PD ≥ 6 months after completing treatment (first recurrence).
Hauptausschlusskritieren: 1. Subject has received neo-adjuvant/adjuvant systemic chemotherapy for primary Stage III or IV disease and:
a. has not had a recurrence or PD prior to entering the study
b. has had a recurrence or PD within 6 months of completing chemotherapy treatment prior to entering the study
Note: Low-dose cisplatin given as a radiation sensitizer or hormonal therapies do not exclude subjects from study participation.
2. Subject has had > 1 recurrence of endometrial cancer.
3. Subject has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1, or anti- programmed cell death-ligand 2 agent.
4. Subject has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, 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. Note: Palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed.
5. Subject has a concomitant malignancy, or subject has a prior non-endometrial invasive malignancy who has been disease-free for < 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed
Prüfarzt: Dr. med. Antje Lehnert

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