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Spots Global Cancer Trial Database for Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Antonio González Martín, MD PhD

Affiliation: Clinica Universitaria de Navarra

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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