Klinische Studie
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer KEYNOTE-826 (MSD MK 3475-826)(MSD MK 3475-826)Phase-3-Studie mit Pembrolizumab (MK-3475) plus Chemotherapie gegenüber Chemotherapie plus Placebo für die Erstlinienbehandlung von persist., rezidiv. oder met. Gebärmutterhalskrebs
Krankheitsentität(en)
Weibliches Genital (z.B. Eierstock, Eileiter, Gebärmutter, Scheide, Schamlippen)
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1 Have persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).
2 Not be pregnant (Appendix 5) or breastfeeding, and at least one of the following conditions applies:
a. Not be a woman of childbearing potential (WOCBP) as defined in Appendix 5 or
b. A WOCBP must agree to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
3 The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
4 Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable only if progression has been demonstrated in such lesions.
5 Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of PD-L1 status prior to randomization.
Wesentliche Ausschlusskriterien1 A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
2 Has known active CNS metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable.
3 Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
4 Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
StatusStudie beendet
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823401fhk-studienzentrum(at)csj.de