A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER
A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.
Inclusion Criteria:
Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.
Exclusion Criteria:
Philadelphia, Pennsylvania 19104, United States
Kelowna, British Columbia V1Y5L3, Canada
Halifax, Nova Scotia B3H 1V7, Canada
Ostrava-Poruba, 708 52, Czechia
Athens/New Kifissia, 14564, Greece
Szolnok, 5000, Hungary
Kita-adachi-gun, Saitama 362-0806, Japan
Bunkyo-ku, Tokyo 113-8655, Japan
Chuo-ku, Tokyo 104-0045, Japan
Krakow, 31-115, Poland
Poznan, 60-569, Poland
Sochi, Krasnodarskiy Kray 354057, Russia
Pyatigorsk, Stavropol Kray 357502, Russia
Moscow, 115478, Russia
Orenburg, 460021, Russia
Saint Petersburg, 197758, Russia
Veliky Novgorod, 173016, Russia
Seoul, 03722, South Korea
Seoul, 06591, South Korea
L'Hospitalet de Llobregat, Barcelona 08908, Spain
Lucerne, Canton of Lucerne 6000, Switzerland
Zurich, 8091, Switzerland
Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
Bebington, Wirral, Merseyside CH63 4JY, United Kingdom
Bebington, Wirral, Merseyside CH63 4JY, United Kingdom