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Brief Title: Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer
Official Title: A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months
Study ID: NCT03598270
Brief Summary: Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after \>100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision. Platinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles. Niraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination. The use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Grand Hôpital de Charleroi, Charleroi, , Belgium
UZ Leuven, Leuven, , Belgium
CHU de Liège, site Sart Tilman, Liège, , Belgium
CHU Ambroise Paré, Mons, , Belgium
CHU UCL Namur site St. Elisabeth, Namur, , Belgium
ICO - Paul Paupin - ANGERS, Angers, , France
CHU Besançon, Besançon, , France
Institut Bergonié, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
ICM Val d'Aurelle, Montpellier, , France
Centre Antoine Lacassagne, Nice, , France
ONCOGARD - Institut de Cancérologie du Gard, Nîmes, , France
Hôpital Cochin, Paris, , France
Hôpital Européen Georges Pompidou, Paris, , France
Groupe Hospitalier Diaconesses-Croix Saint Simon, Paris, , France
Hôpital Tenon, Paris, , France
HPCA Cario, Plérin Cedex, , France
Institut Curie - Hopital Claudius Régaud, Saint-Cloud, , France
Institut Curie - Hôpital René Huguenin- SAINT CLOUD, Saint-Cloud, , France
ICO Centre René Gauducheau, Saint-Herblain, , France
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, , France
Gustave Roussy, Villejuif, , France
Hochtaunus-Kliniken, Bad Homburg, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem, Hamburg, , Germany
Diakovere Krankenhaus, Hannover, , Germany
Klinikum Kulmbach, Kulmbach, , Germany
Universitätsklinikum Mannheim, Mannheim, , Germany
Universitätsklinikum Münster, Münster, , Germany
MVZ Nordhausen, Nordhausen, , Germany
Klinikum Oldenburg AöR, Oldenburg, , Germany
ROMed Klinikum Rosenheim, Rosenheim, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsfrauenklinik Ulm, Ulm, , Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden, , Germany
Spedali Civili, Brescia, , Italy
Asst Lecco, Lecco, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
I.R.C.C.S. Istituto Oncologico Veneto, Padova, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
AO Città della Salute e della Scienza- Ospedale Sant'Anna, Torino, , Italy
Ospedale Mauriziano Umberto I, Torino, , Italy
Hospital de Sabadell, Sabadell, Barcelona, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Complejo Hospitalario Universitario de A Coruña, A Coruña, , Spain
ICO Badalona, Badalona, , Spain
H. Clínic Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital de la Vall d'Hebron, Barcelona, , Spain
H Reina Sofía Cordoba, Cordoba, , Spain
ICO Girona, Girona, , Spain
ICO Hospitalet, Hospitalet del Llobregat, , Spain
Hospital de León, León, , Spain
Clinica Universitaria de Navarra, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Gregorio Marañon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
H Morales Meseguer, Murcia, , Spain
Complejo Hospitalario Regional de Málaga, Málaga, , Spain
Hospital Son Llatzer, Palma De Mallorca, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
H La Fe de Valencia, Valencia, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Name: Antonio González Martín, MD PhD
Affiliation: Clinica Universitaria de Navarra
Role: PRINCIPAL_INVESTIGATOR