Clinical trial • Phase III • Oncology|Rare Disease

DOSTARLIMAB for Non-mucinous epithelial ovarian cancer (stage III or IV)

Phase III trial of DOSTARLIMAB for Non-mucinous epithelial ovarian cancer (stage III or IV).

Overview

Trial Therapeutic Area: Oncology|Rare Disease
Trial Disease: Non-mucinous epithelial ovarian cancer (stage III or IV)
Trial Stage: Phase III
Drug Modality: Monoclonal antibody|Small molecule
Orphan Drug: Yes

Key dates

Initial CTIS Submission Date: 01-03-2024
First CTIS Authorization Date: 10-04-2024

Trial design

Randomised, standard of care (soc) platinum-based therapy (paclitaxel and carboplatin on day 1 of a 21-day cycle; bevacizumab may be administered every 21 days per local practice soc if determined prior to randomization). comparator arms include soc with placebo controls for dostarlimab and/or niraparib as applicable (treatment arm 1 = soc + dostarlimab placebo then niraparib placebo; arm 2 = soc + dostarlimab placebo then niraparib maintenance; arm 3 = soc + dostarlimab then niraparib maintenance). Phase III trial in Czechia, Norway, Netherlands and others.

Randomised: Yes
Comparator: Standard of care (SOC) platinum-based therapy (paclitaxel and carboplatin on Day 1 of a 21-day cycle; bevacizumab may be administered every 21 days per local practice SOC if determined prior to randomization). Comparator arms include SOC with placebo controls for dostarlimab and/or niraparib as applicable (Treatment Arm 1 = SOC + dostarlimab placebo then niraparib placebo; Arm 2 = SOC + dostarlimab placebo then niraparib maintenance; Arm 3 = SOC + dostarlimab then niraparib maintenance).
Target Sample Size: 708

Eligibility

Recruits 708 Vulnerable population flag is selected. All participants must be ≥18 years and "able to understand the study procedures, and agree to participate in the study by providing written informed consent." Country-specific SIS-ICF (subject information and informed consent form) documents are provided (multiple language versions and country templates are available in the dossier). A Power of Attorney form is present for Denmark (indicating provisions for legally authorised representatives where applicable). No paediatric assent processes are applicable because enrollment is restricted to adults..

Pregnancy Exclusion: 6. Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use, during niraparib treatment and for 30 days after receiving the final dose of study treatment).
Vulnerable Population: Vulnerable population flag is selected. All participants must be ≥18 years and "able to understand the study procedures, and agree to participate in the study by providing written informed consent." Country-specific SIS-ICF (subject information and informed consent form) documents are provided (multiple language versions and country templates are available in the dossier). A Power of Attorney form is present for Denmark (indicating provisions for legally authorised representatives where applicable). No paediatric assent processes are applicable because enrollment is restricted to adults.

Inclusion criteria

{"criterion_text":"- 1. Participants must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.\n- 2. Participants with a histologically confirmed diagnosis of high-grade nonmucinous epithelial ovarian (serous, endometrioid, clear cell, carcinosarcoma, and mixed pathologies), fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the FIGO or tumor, node and metastasis staging criteria [i.e., American Joint Committee on Cancer].\n- 3. All participants with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo PDS (R0 or macroscopic disease), or those for whom NACT is planned.\n- 4. Participants with Stage III are eligible if they meet one or more of the following criteria: a. Stage IIIC participants CC0 resection if they meet the following criteria: aggregate ≥ 5 cm extra-pelvic disease during PDS as assessed by the Investigator. b. All participants with inoperable Stage III disease. c. All Stage III participants with macroscopic residual tumor (per Investigator judgment) following PDS. d. All Stage III participants for whom NACT is planned.\n- 5. Participant must provide a blood sample for ctDNA HRR testing at PreScreening or Screening.\n- 6. Participant must provide sufficient tumor tissue sample (a minimum of 1 FFPE block or slide at Pre-Screening or Screening) for programmed death ligand 1 (PD-L1), HRD testing.\n- 7. Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 3 days prior to receiving the first dose of study treatment.\n- 8. Participants must be postmenopausal, free from menses for >1 year, surgically sterilized, or willing to use highly effective contraception to prevent pregnancy or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 180 days after the last dose of study treatment.\n- 9. Participants must have adequate organ function, defined as follows (Note: CBC test should be obtained without transfusion or receipt of stimulating factors within 2 weeks before obtaining Screening blood sample): a. Absolute neutrophil count ≥1,500/µL b. Platelet count ≥100,000/µL c. Hemoglobin ≥9 g/dL d. Serum creatinine ≤1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft Gault equation e. Total bilirubin ≤1.5 × ULN or direct bilirubin ≤1.5 × ULN f. Aspartate aminotransferase and alanine aminotransferase (ALT) ≤2.5 × ULN unless liver metastases are present, in which case they must be ≤5 × ULN\n- 10. Participants must have an ECOG score of 0 or 1.\n- 11. Participants must have normal BP or adequately treated and controlled hypertension (systolic BP ≤140 mmHg and/or diastolic BP ≤90 mmHg).\n- 12. Participants must agree to complete HRQoL questionnaires throughout the study.\n- 13. Participants must be able to take oral medication."}

Exclusion criteria

{"criterion_text":"- 1. Participant has mucinous, germ cell, transitional cell, or undifferentiated tumor.\n- 2. Participant has low grade or Grade 1 epithelial ovarian cancer.\n- 3. Stage III participant with CC0 resection after PDS (i.e., no macroscopic residual disease, unless inclusion criterion #4a is met).\n- 4. Participant has not adequately recovered from prior major surgery.\n- 5. Participant has a known condition, therapy, or laboratory abnormality that might confound the study results or interfere with the participant's participation for the full duration of the study treatment in the opinion of the Investigator.\n- 6. Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use, during niraparib treatment and for 30 days after receiving the final dose of study treatment).\n- 7. Participant has known active central nervous system metastases, carcinomatous meningitis, or both.\n- 8. Participant has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina <6 months to enrollment, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident within 6 months).\n- 9. Participant has a bowel obstruction by clinical symptoms or CT scan, subocclusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra abdominal abscess.\n- 10. Participant initiating bevacizumab as SOC has proteinuria as demonstrated by urine protein:creatinine ratio ≥1.0 at Screening or urine dipstick for proteinuria ≥2 (participants discovered to have ≥2 proteinuria on dipstick at baseline should undergo a 24 hour urine collection and must demonstrate <2 g of protein in 24 hours to be eligible).\n- 11. Participant has any known history or current diagnosis of MDS or AML.\n- 12. Participant has been diagnosed and/or treated with any therapy for invasive cancer <5 years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy (e.g., trastuzumab) less than 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment. Participants with definitively treated non- invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, Grade 1 or 2, Stage I endometrial cancer, or nonmelanomatous skin cancer are allowed.\n- 13. Participant is at increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).\n- 14. Participant is immunocompromised. Participants with splenectomy are allowed. Participants with known HIV are allowed if they meet all criteria as listed in the protocol. a. Cluster of differentiation 4 ≥350/µL and viral load <400 copies/mL b. No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment c. No history of HIV associated malignancy for the past 5 years d. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started >4 weeks prior to study enrollment.\n- 15. Participant has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative] is detected).\n- 16. Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease, or uncontrolled infection.\n- 17. Participant has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.\n- 18. Participant has received a live vaccine within 14 days of planned start of study therapy. Seasonal influenza vaccines that do not contain live viruses are allowed.\n- 19. Participant has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, dostarlimab, or their excipients.\n- 20. Prior treatment for high-grade nonmucinous epithelial ovarian, fallopian tube, or peritoneal cancer (immunotherapy, anticancer therapy, radiation therapy).\n- 21. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone or insulin).\n- 22. Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment."}

Endpoints

Primary endpoints

{"endpoint_text":"- The primary efficacy endpoint PFS is defined as the time from the date of randomization to the date of first documentation of progression or death by any cause, whichever occurs first","definition_or_measurement_approach":"PFS = time from randomization to first documentation of progression or death by any cause, whichever occurs first (investigator assessment as primary; BICR used as a secondary assessment per RECIST v1.1)."}

Secondary endpoints

{"endpoint_text":"- 1. Overall survival (OS)","definition_or_measurement_approach":"Overall survival (OS): time from randomization to death from any cause."}
{"endpoint_text":"- 2. BICR determined PFS per RECIST v1.1 criteria","definition_or_measurement_approach":"Progression-Free Survival assessed by Blinded Independent Central Review (BICR) using RECIST v1.1 criteria."}
{"endpoint_text":"- 3. The absolute scores and change from baseline in the EQ-5D-5L Visual Analogue Score (VAS) and Health Utility Index (HUI) HRQoL assessments","definition_or_measurement_approach":"Health-related quality of life (HRQoL) assessments: absolute scores and change from baseline in EQ-5D-5L VAS and HUI."}
{"endpoint_text":"- 4. The absolute scores and change from baseline in the EORTC QLQ C30, and EORTC QLQ OV28 HRQoL assessments","definition_or_measurement_approach":"HRQoL assessed via EORTC QLQ-C30 and EORTC QLQ-OV28: absolute scores and change from baseline."}
{"endpoint_text":"- 5. TFST, defined as the time from the date of randomization to the start date of the first subsequent anticancer therapy or death by any cause, whichever occurs first","definition_or_measurement_approach":"TFST = time from randomization to start of first subsequent anticancer therapy or death, whichever occurs first."}
{"endpoint_text":"- 6. TSST, defined as the time from the date of randomization to the start date of the second subsequent anticancer therapy or death by any cause, whichever occurs first treatment or death by any cause (PFS2)","definition_or_measurement_approach":"TSST = time from randomization to start of second subsequent anticancer therapy or death, whichever occurs first."}
{"endpoint_text":"- 7. PFS2, defined as the time from the date of randomization to the date of first PD per Investigator’s assessment after initiation of subsequent anticancer therapy or death by any cause, whichever occurs first","definition_or_measurement_approach":"PFS2 = time from randomization to first progressive disease (PD) per investigator assessment after initiation of subsequent anticancer therapy or death, whichever occurs first."}
{"endpoint_text":"- 8. ORR, defined as the proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1 by Investigator assessment, for participants with measurable disease at baseline","definition_or_measurement_approach":"ORR = proportion with CR or PR per RECIST v1.1 by investigator assessment among participants with measurable disease at baseline."}
{"endpoint_text":"- 9. DOR, defined as the time from first documentation of CR or PR until the time of first documentation of PD per RECIST v1.1 criteria by Investigator assessment, or death by any cause, whichever occurs first for participants with measurable disease at baseline","definition_or_measurement_approach":"DOR = time from first documentation of CR or PR to first documentation of PD per RECIST v1.1 by investigator assessment, or death, whichever occurs first (measurable disease cohort)."}
{"endpoint_text":"- 10. DCR, defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD), per RECIST v1.1 by Investigator assessment, for participants with measurable disease at baseline","definition_or_measurement_approach":"DCR = proportion with best overall response of CR, PR, or SD per RECIST v1.1 by investigator assessment among participants with measurable disease at baseline."}

Other endpoints

{"endpoint_text":"- Pharmacokinetics (PK) and immunogenicity of dostarlimab\n- PK of niraparib","definition_or_measurement_approach":"PK and immunogenicity assessments of dostarlimab; PK assessments of niraparib (as listed among secondary objectives). Specific sampling/assay details are provided in study protocol and bioanalytical appendices."}

Recruitment

Planned Sample Size: 708
Recruitment Window Months: 129
Consent Approach: Informed consent is obtained in writing from each participant (participants must be ≥18 and able to provide written informed consent). Country-specific SIS-ICF (subject information and consent) documents are provided in multiple language versions and as local templates (e.g., German, Czech, Dutch, Danish, Greek, Spanish, French, Italian, Norwegian, Polish, Romanian, Finnish, etc., as per the dossier). A Power of Attorney form is available in Denmark indicating provisions for legally authorised representatives where applicable. PACT addenda and PACT-related consent addenda are available for continuation phases where applicable.

Geography

Total Number Of Sites: 84
Total Number Of Participants: 947

Czechia

Earliest CTIS Part Ii Submission Date: 25-03-2024
Latest Decision Or Authorization Date: 10-04-2024
Processing Time Days: 16
Number Of Sites: 2
Number Of Participants: 18

Sites

Site Name: Vseobecna Fakultni Nemocnice V Praze
Department Name: Gynekologickoporodnická klinika
Principal Investigator Name: David Cibula
Principal Investigator Email: dc@davidcibula.cz
Contact Person Name: David Cibula
Contact Person Email: dc@davidcibula.cz

Site Name: Fakultni Nemocnice Bulovka
Department Name: Gynekologicko porodnická klinika
Principal Investigator Name: Michal Zikán
Principal Investigator Email: michal.zikan@bulovka.cz
Contact Person Name: Michal Zikán
Contact Person Email: michal.zikan@bulovka.cz

Norway

Earliest CTIS Part Ii Submission Date: 25-03-2024
Latest Decision Or Authorization Date: 22-04-2024
Processing Time Days: 28
Number Of Sites: 1
Number Of Participants: 26

Sites

Site Name: Oslo University Hospital HF
Department Name: Avdelingen av Gynecologic Oncology
Principal Investigator Name: Kristina Lindemann
Principal Investigator Email: klinde@ous-hf.no
Contact Person Name: Kristina Lindemann
Contact Person Email: klinde@ous-hf.no

Netherlands

Earliest CTIS Part Ii Submission Date: 19-04-2024
Latest Decision Or Authorization Date: 10-04-2024
Processing Time Days: -9
Number Of Sites: 5
Number Of Participants: 38

Sites

Site Name: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name: Medical Oncology
Principal Investigator Name: Ingrid Boere
Principal Investigator Email: i.boere@erasmusmc.nl
Contact Person Name: Ingrid Boere
Contact Person Email: i.boere@erasmusmc.nl

Site Name: Academisch Medisch Centrum
Department Name: Medical Oncology
Principal Investigator Name: Jaqueline Tromp
Principal Investigator Email: J.m.tromp@amc.uva.nl
Contact Person Name: Jaqueline Tromp
Contact Person Email: J.m.tromp@amc.uva.nl

Site Name: University Hospital Maastricht
Department Name: Internal Medicine, section Medical Oncology
Principal Investigator Name: Roy Lalisang
Principal Investigator Email: roy.lalisang@mumc.nl
Contact Person Name: Roy Lalisang
Contact Person Email: roy.lalisang@mumc.nl

Site Name: Universitair Medisch Centrum Utrecht
Department Name: Medical Oncology
Principal Investigator Name: Inge Baas
Principal Investigator Email: i.o.baas-3@umcutrecht.nl
Contact Person Name: Inge Baas
Contact Person Email: i.o.baas-3@umcutrecht.nl

Site Name: Radboud universitair medisch centrum / RADBOUDUMC
Department Name: Medical Oncology
Principal Investigator Name: Petronella Ottevanger
Principal Investigator Email: nelleke.ottevanger@radboudumc.nl
Contact Person Name: Petronella Ottevanger
Contact Person Email: nelleke.ottevanger@radboudumc.nl

Italy

Earliest CTIS Part Ii Submission Date: 24-04-2024
Latest Decision Or Authorization Date: 11-04-2024
Processing Time Days: 17
Number Of Sites: 4
Number Of Participants: 80

Sites

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: Oncologia Medica
Principal Investigator Name: Claudio Zamagni
Principal Investigator Email: claudio.zamagni@aosp.bo.it
Contact Person Name: Claudio Zamagni
Contact Person Email: claudio.zamagni@aosp.bo.it

Site Name: Azienda Unita Sanitaria Locale Della Romagna
Department Name: Dipt. di Oncologia ed Ematologia
Principal Investigator Name: Stefano Tamberi
Principal Investigator Email: ste.tamberi@gmail.com
Contact Person Name: Stefano Tamberi
Contact Person Email: ste.tamberi@gmail.com

Site Name: Istituto Nazionale Dei Tumori
Department Name: Oncologia Medica B
Principal Investigator Name: Sandro Pignata
Principal Investigator Email: s.pignata@istitutotumori.na.it
Contact Person Name: Sandro Pignata
Contact Person Email: s.pignata@istitutotumori.na.it

Site Name: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name: Oncologia Medica
Principal Investigator Name: Alberto Farolfi
Principal Investigator Email: alberto.farolfi@irst.emr.it
Contact Person Name: Alberto Farolfi
Contact Person Email: alberto.farolfi@irst.emr.it

Spain

Earliest CTIS Part Ii Submission Date: 24-04-2024
Latest Decision Or Authorization Date: 10-04-2024
Processing Time Days: 16
Number Of Sites: 10
Number Of Participants: 60

Sites

Site Name: Hospital Universitario De Toledo
Department Name: Servicio de Oncología - Investigación Clínica
Principal Investigator Name: Maria del Carmen Esteban
Principal Investigator Email: cesteban@sescam.jccm.es
Contact Person Name: Maria del Carmen Esteban
Contact Person Email: cesteban@sescam.jccm.es

Site Name: Hospital Clinico Universitario De Valencia
Department Name: Servicio de Hematología y Oncología Médica
Principal Investigator Name: Jose Alejandro Pérez Fidalgo
Principal Investigator Email: japfidalgo@msn.com
Contact Person Name: Jose Alejandro Pérez Fidalgo
Contact Person Email: japfidalgo@msn.com

Site Name: Hospital Universitario La Paz
Department Name: Servicio de Oncología
Principal Investigator Name: Andres Redondo
Principal Investigator Email: andres.redondo@salud.madrid.org
Contact Person Name: Andres Redondo
Contact Person Email: andres.redondo@salud.madrid.org

Site Name: Institut Catala D'oncologia
Department Name: Servicio de Oncología
Principal Investigator Name: Maria Pilar Barretina Ginesta
Principal Investigator Email: mpbarretina@iconcologia.net
Contact Person Name: Maria Pilar Barretina Ginesta
Contact Person Email: mpbarretina@iconcologia.net

Site Name: Hospital Universitario Infanta Sofía
Department Name: Medical Oncology
Principal Investigator Name: Maria Merino Salvador
Principal Investigator Email: mmerinos.hulp@salud.madrid.org
Contact Person Name: Maria Merino Salvador
Contact Person Email: mmerinos.hulp@salud.madrid.org

Site Name: Hospital Clinico Universitario Lozano Blesa
Department Name: Department of Oncology
Principal Investigator Name: Alfonso Yubero Esteban
Principal Investigator Email: ayuberoe@salud.aragon.es
Contact Person Name: Alfonso Yubero Esteban
Contact Person Email: ayuberoe@salud.aragon.es

Site Name: Complexo Hospitalario Universitario De Santiago
Department Name: Servicio de Oncología Medica
Principal Investigator Name: Juan Cueva
Principal Investigator Email: juan.fernando.cueva.banuelos@sergas.es
Contact Person Name: Juan Cueva
Contact Person Email: juan.fernando.cueva.banuelos@sergas.es

Site Name: Hospital Germans Trias I Pujol
Department Name: Oncology Department
Principal Investigator Name: Pau Guillén Sentis
Principal Investigator Email: pguillens@iconcologia.net
Contact Person Name: Pau Guillén Sentis
Contact Person Email: pguillens@iconcologia.net

Site Name: Hospital Universitario De Jaen
Department Name: Oncology
Principal Investigator Name: Irene Martinez Martín
Principal Investigator Email: irenemm225@gmail.com
Contact Person Name: Irene Martinez Martín
Contact Person Email: irenemm225@gmail.com

Site Name: Hospital Clinic De Barcelona
Department Name: Inter-Unit
Principal Investigator Name: Lydia Gaba
Principal Investigator Email: lgaba@clinic.cat
Contact Person Name: Lydia Gaba
Contact Person Email: lgaba@clinic.cat

Belgium

Earliest CTIS Part Ii Submission Date: 19-04-2024
Latest Decision Or Authorization Date: 17-04-2024
Processing Time Days: 28
Number Of Sites: 3
Number Of Participants: 34

Sites

Site Name: Algemeen Ziekenhuis Klina
Department Name: Digestive Oncology
Principal Investigator Name: Wim Demey
Principal Investigator Email: wim.demey@klina.be
Contact Person Name: Wim Demey
Contact Person Email: wim.demey@klina.be

Site Name: CHU Saint Pierre
Department Name: Oncology
Principal Investigator Name: Corina Martinez-Mena
Principal Investigator Email: corina_martinez-mena@stpierrebru.be
Contact Person Name: Corina Martinez-Mena
Contact Person Email: corina_martinez-mena@stpierrebru.be

Site Name: Az St-Jan Brugge-Oostende A.V.
Department Name: Medical Oncology
Principal Investigator Name: Eveline De Cuypere
Principal Investigator Email: eveline.decuypere@azsintjan.be
Contact Person Name: Eveline De Cuypere
Contact Person Email: eveline.decuypere@azsintjan.be

France

Earliest CTIS Part Ii Submission Date: 26-04-2024
Latest Decision Or Authorization Date: 15-04-2024
Processing Time Days: 11
Number Of Sites: 36
Number Of Participants: 400

Sites

Site Name: Centre Hospitalier Lyon Sud
Department Name: Service d'Hépato-Gastroentérologie
Principal Investigator Name: Benoit You
Principal Investigator Email: benoit.you@chu-lyon.fr
Contact Person Name: Benoit You
Contact Person Email: benoit.you@chu-lyon.fr

Site Name: Hopital De La Croix Rousse
Department Name: Oncologie médicale
Principal Investigator Name: Benoit You
Principal Investigator Email: benoit.you@chu-lyon.fr
Contact Person Name: Benoit You
Contact Person Email: benoit.you@chu-lyon.fr

Site Name: Institut Regional Du Cancer De Montpellier
Department Name: Department d'Oncologie Médicale
Principal Investigator Name: Véronique D Hondt
Principal Investigator Email: veronique.dhondt@icm.unicancer.fr
Contact Person Name: Véronique D Hondt
Contact Person Email: veronique.dhondt@icm.unicancer.fr

Site Name: Institut Gustave Roussy
Department Name: Département d'Oncologie médicale
Principal Investigator Name: Alexandra Leary
Principal Investigator Email: alexandra.leary@gustaveroussy.fr
Contact Person Name: Alexandra Leary
Contact Person Email: alexandra.leary@gustaveroussy.fr

Site Name: Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name: Unite Onco sein Gyneco
Principal Investigator Name: Julien Grenier
Principal Investigator Email: j.grenier@isc84.org
Contact Person Name: Julien Grenier
Contact Person Email: j.grenier@isc84.org

Site Name: Les Hopitaux Universitaires De Strasbourg
Department Name: Pôle d'Onco-hématologie
Principal Investigator Name: Jean-Emmanuel Kurtz
Principal Investigator Email: je.kurtz@icans.eu
Contact Person Name: Jean-Emmanuel Kurtz
Contact Person Email: je.kurtz@icans.eu

Site Name: Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name: Service d'Oncologie Médicale
Principal Investigator Name: Frédéric Selle
Principal Investigator Email: fselle@hopital-dcss.org
Contact Person Name: Frédéric Selle
Contact Person Email: fselle@hopital-dcss.org

Site Name: Centr Georges Francois Leclerc
Department Name: Oncologie Médicale
Principal Investigator Name: Laure Favier
Principal Investigator Email: lfavier@cgfl.fr
Contact Person Name: Laure Favier
Contact Person Email: lfavier@cgfl.fr

Site Name: Centre Francois Baclesse
Department Name: Département de cancérologie gynécologique
Principal Investigator Name: Florence Joly
Principal Investigator Email: f.joly@baclesse.unicancer.fr
Contact Person Name: Florence Joly
Contact Person Email: f.joly@baclesse.unicancer.fr

Site Name: Institut Curie
Department Name: Oncologie médicale
Principal Investigator Name: Manuel Rodrigues
Principal Investigator Email: manuel.rodrigues@curie.fr
Contact Person Name: Manuel Rodrigues
Contact Person Email: manuel.rodrigues@curie.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Oncologie médicale
Principal Investigator Name: Jacques Medioni
Principal Investigator Email: jacques.medioni@aphp.fr
Contact Person Name: Jacques Medioni
Contact Person Email: jacques.medioni@aphp.fr

Site Name: Centre Oscar Lambret
Department Name: Département de Cancérologie Gynécologique
Principal Investigator Name: Cyril Abdeddaim
Principal Investigator Email: c-abdeddaim@o-lambret.fr
Contact Person Name: Cyril Abdeddaim
Contact Person Email: c-abdeddaim@o-lambret.fr

Site Name: Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name: Oncologie médicale
Principal Investigator Name: Laurence Gladieff
Principal Investigator Email: gladieff.laurence@iuct-oncopole.fr
Contact Person Name: Laurence Gladieff
Contact Person Email: gladieff.laurence@iuct-oncopole.fr

Site Name: Clinique Victor Hugo
Department Name: Oncologie médicale
Principal Investigator Name: Sophie Roche
Principal Investigator Email: essaisroche@ilcgroupe.fr
Contact Person Name: Sophie Roche
Contact Person Email: essaisroche@ilcgroupe.fr

Site Name: Hopital Prive Des Cotes D'armor
Department Name: Oncologie
Principal Investigator Name: Anne-Claire Hardy-Bessard
Principal Investigator Email: ac.hardy@cario-sante.fr
Contact Person Name: Anne-Claire Hardy-Bessard
Contact Person Email: ac.hardy@cario-sante.fr

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: Oncologie médicale
Principal Investigator Name: Pierre Cornillon
Principal Investigator Email: pierre.cornillon@chu-st-etienne.fr
Contact Person Name: Pierre Cornillon
Contact Person Email: pierre.cornillon@chu-st-etienne.fr

Site Name: Institut Godinot
Department Name: Oncologie médicale
Principal Investigator Name: Aude-Marie Savoye
Principal Investigator Email: aude-marie.savoye@reims.unicancer.fr
Contact Person Name: Aude-Marie Savoye
Contact Person Email: aude-marie.savoye@reims.unicancer.fr

Site Name: L'Hopital Prive Du Confluent
Department Name: Oncologie médicale
Principal Investigator Name: Alain Lortholary
Principal Investigator Email: alain.lortholary@groupeconfluent.fr
Contact Person Name: Alain Lortholary
Contact Person Email: alain.lortholary@groupeconfluent.fr

Site Name: Clinique Clementville
Department Name: Oncologie médicale
Principal Investigator Name: Emmanuel Guardiola
Principal Investigator Email: emmanuel.guardiola@oncoclem.org
Contact Person Name: Emmanuel Guardiola
Contact Person Email: emmanuel.guardiola@oncoclem.org

Site Name: Centre Hospitalier De Cholet
Department Name: Oncologie médicale
Principal Investigator Name: Victor Simmet
Principal Investigator Email: victor.simmet@ch-cholet.fr
Contact Person Name: Victor Simmet
Contact Person Email: victor.simmet@ch-cholet.fr

Site Name: Medipole De Nancy
Department Name: Oncologie
Principal Investigator Name: Fabien Brocard
Principal Investigator Email: f.brocard@oncog.fr
Contact Person Name: Fabien Brocard
Contact Person Email: f.brocard@oncog.fr

Site Name: Institut Paoli Calmettes
Department Name: Oncologie médicale
Principal Investigator Name: Renaud Sabatier
Principal Investigator Email: sabatierr@ipc.unicancer.fr
Contact Person Name: Renaud Sabatier
Contact Person Email: sabatierr@ipc.unicancer.fr

Site Name: Institut De Cancerologie De L Ouest
Department Name: Département d'Oncologie
Principal Investigator Name: Sophie Abadie-Lacourtoisie
Principal Investigator Email: sophie.abadie-lacourtoisie@ico.unicancer.fr
Contact Person Name: Sophie Abadie-Lacourtoisie
Contact Person Email: sophie.abadie-lacourtoisie@ico.unicancer.fr

Site Name: Institut Curie (Saint-Cloud)
Department Name: Oncologie médicale
Principal Investigator Name: Manuel Rodrigues
Principal Investigator Email: manuel.rodrigues@curie.fr
Contact Person Name: Manuel Rodrigues
Contact Person Email: manuel.rodrigues@curie.fr

Site Name: Centre Leon Berard
Department Name: Oncologie médicale
Principal Investigator Name: Isabelle Ray-Coquard
Principal Investigator Email: isabelle.ray-coquard@lyon.unicancer.fr
Contact Person Name: Isabelle Ray-Coquard
Contact Person Email: isabelle.ray-coquard@lyon.unicancer.fr

Site Name: Centre Hospitalier Universitaire Grenoble Alpes (La Tronche)
Department Name: Oncologie Medicale et Hématologie
Principal Investigator Name: Elise Bonnet
Principal Investigator Email: elise.bonnet@lyon.unicancer.fr
Contact Person Name: Elise Bonnet
Contact Person Email: elise.bonnet@lyon.unicancer.fr

Site Name: Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name: Oncologie médicale
Principal Investigator Name: Thibault De La Motte Rouge
Principal Investigator Email: t.delamotterouge@rennes.unicancer.fr
Contact Person Name: Thibault De La Motte Rouge
Contact Person Email: t.delamotterouge@rennes.unicancer.fr

Denmark

Earliest CTIS Part Ii Submission Date: 24-04-2024
Latest Decision Or Authorization Date: 10-04-2024
Processing Time Days: 16
Number Of Sites: 3
Number Of Participants: 40

Sites

Site Name: Region Sjaelland
Department Name: Onkologisk Afdeling
Principal Investigator Name: Dejan Labudovic
Principal Investigator Email: dejl@regionsjaelland.dk
Contact Person Name: Dejan Labudovic
Contact Person Email: dejl@regionsjaelland.dk

Site Name: Region Hovedstaden
Department Name: Department of Oncology
Principal Investigator Name: Nicoline Raaschou-Jensen
Principal Investigator Email: nicoline.raaschoujensen.01@regionh.dk
Contact Person Name: Nicoline Raaschou-Jensen
Contact Person Email: nicoline.raaschoujensen.01@regionh.dk

Site Name: Rigshospitalet
Department Name: Department of Oncology 5073
Principal Investigator Name: Hanne From Mathiesen
Principal Investigator Email: hanne.from.mathiesen@regionh.dk
Contact Person Name: Hanne From Mathiesen
Contact Person Email: hanne.from.mathiesen@regionh.dk

Romania

Earliest CTIS Part Ii Submission Date: 24-04-2024
Latest Decision Or Authorization Date: 11-04-2024
Processing Time Days: 17
Number Of Sites: 4
Number Of Participants: 80

Sites

Site Name: Medisprof S.R.L.
Department Name: Oncologie Medicala
Principal Investigator Name: Udrea Anghel-Adrian
Principal Investigator Email: adrianudrea@medisprof.ro
Contact Person Name: Udrea Anghel-Adrian
Contact Person Email: adrianudrea@medisprof.ro

Site Name: Centrul De Oncologie SF Nectarie S.R.L.
Department Name: Oncologie Medicala
Principal Investigator Name: Michael Schenker
Principal Investigator Email: mike_schenker@yahoo.com
Contact Person Name: Michael Schenker
Contact Person Email: mike_schenker@yahoo.com

Site Name: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name: Oncologie Medicala
Principal Investigator Name: Aurelia Alexandru
Principal Investigator Email: auralexandru@yahoo.com
Contact Person Name: Aurelia Alexandru
Contact Person Email: auralexandru@yahoo.com

Site Name: Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name: Oncologie Medicala
Principal Investigator Name: Eliade Ciuleanu Tudor
Principal Investigator Email: tudor_ciuleanu@hotmail.com
Contact Person Name: Eliade Ciuleanu Tudor
Contact Person Email: tudor_ciuleanu@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date: 26-04-2024
Latest Decision Or Authorization Date: 24-04-2024
Processing Time Days: -2
Number Of Sites: 3
Number Of Participants: 36

Sites

Site Name: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name: Klinika Ginekologii Onkologicznej
Principal Investigator Name: Mariusz Bidziński
Principal Investigator Email: sekretariatgin@nio.gov.pl
Contact Person Name: Mariusz Bidziński
Contact Person Email: sekretariatgin@nio.gov.pl

Site Name: Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name: Klinika Ginekologii Operacyjneji Onkologii Ginekologicznej Dorosłychi Dziewcząt
Principal Investigator Name: Anita ChudeckaGłaz
Principal Investigator Email: cwbk@pum.edu.pl
Contact Person Name: Anita ChudeckaGłaz
Contact Person Email: cwbk@pum.edu.pl

Site Name: Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name: KLINIKA ONKOLOGII I IMMUNO ONKOLOGI I ZODDZIA ŁEM DZIENNYM TERAPII ONKOLOGICZNEJ
Principal Investigator Name: Monika Kotyla
Principal Investigator Email: sek.chemioterapia@poliklinika.net
Contact Person Name: Monika Kotyla
Contact Person Email: sek.chemioterapia@poliklinika.net

Greece

Earliest CTIS Part Ii Submission Date: 27-05-2024
Latest Decision Or Authorization Date: 22-05-2024
Processing Time Days: -5
Number Of Sites: 4
Number Of Participants: 50

Sites

Site Name: Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.
Department Name: 3rd Department of Medical Oncology
Principal Investigator Name: Evangelia Razis
Principal Investigator Email: erazis@hygeia.gr
Contact Person Name: Evangelia Razis
Contact Person Email: erazis@hygeia.gr

Site Name: Alexandra Hospital
Department Name: Clinical Therapeutics Department
Principal Investigator Name: Flora Zagouri
Principal Investigator Email: florazagouri@yahoo.co.uk
Contact Person Name: Flora Zagouri
Contact Person Email: florazagouri@yahoo.co.uk

Site Name: Areteio Hospital
Department Name: Oncology Dept.
Principal Investigator Name: Christos Papadimitriou
Principal Investigator Email: chr_papadim@yahoo.gr
Contact Person Name: Christos Papadimitriou
Contact Person Email: chr_papadim@yahoo.gr

Site Name: University General Hospital Attikon
Department Name: 4th Department of Internal Medicine
Principal Investigator Name: Anna Koumarianou
Principal Investigator Email: akoumari@yahoo.com
Contact Person Name: Anna Koumarianou
Contact Person Email: akoumari@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date: 26-04-2024
Latest Decision Or Authorization Date: 15-04-2024
Processing Time Days: 11
Number Of Sites: 5
Number Of Participants: 45

Sites

Site Name: Klinikum Wolfsburg
Department Name: Department of Gynecology and obstetrics
Principal Investigator Name: Andreas Reichl
Principal Investigator Email: andreas.reichl@klinikum.wolfsburg.de
Contact Person Name: Andreas Reichl
Contact Person Email: andreas.reichl@klinikum.wolfsburg.de

Site Name: MVZ fuer Haematologie und Onkologie Ravensburg GmbH
Department Name: Women’s Clinic,Breast center, Gynecological Cancer Center
Principal Investigator Name: Martina Gropp-Meier
Principal Investigator Email: martina.groppmeier@oberschwabenklinik.de
Contact Person Name: Martina Gropp-Meier
Contact Person Email: martina.groppmeier@oberschwabenklinik.de

Site Name: Universitaetsklinikum Muenster AöR
Department Name: UKM Gynaecology Department
Principal Investigator Name: Ralf Witteler
Principal Investigator Email: ralf.witteler@ukmuenster.de
Contact Person Name: Ralf Witteler
Contact Person Email: ralf.witteler@ukmuenster.de

Site Name: HELIOS Klinikum Berlin-Buch GmbH
Department Name: Gynaecology Department
Principal Investigator Name: Sabine Rothe
Principal Investigator Email: sabine.rothe@helios-gesundheit.de
Contact Person Name: Sabine Rothe
Contact Person Email: sabine.rothe@helios-gesundheit.de

Site Name: Albertinen-Krankenhaus/Albertinen-Haus gGmbH
Department Name: Gynaecology Department
Principal Investigator Name: Ulrike Dörste
Principal Investigator Email: ulrike.doerste@albertinen.de
Contact Person Name: Ulrike Dörste
Contact Person Email: ulrike.doerste@albertinen.de

Finland

Earliest CTIS Part Ii Submission Date: 24-04-2024
Latest Decision Or Authorization Date: 10-04-2024
Processing Time Days: 16
Number Of Sites: 4
Number Of Participants: 40

Sites

Site Name: Tampere University Hospital
Department Name: Obstetrics and Gynecology
Principal Investigator Name: Annika Auranen
Principal Investigator Email: annika.auranen@pirha.fi
Contact Person Name: Annika Auranen
Contact Person Email: annika.auranen@pirha.fi

Site Name: HUS-Yhtymae
Department Name: Comprehensive Cancer Center - Syopakeskus Gynecologic Oncology Outpatient Clinic
Principal Investigator Name: Mikko Loukovaar
Principal Investigator Email: mikko.loukovaara@hus.fi
Contact Person Name: Mikko Loukovaar
Contact Person Email: mikko.loukovaara@hus.fi

Site Name: Pohjois-Savon hyvinvointialue
Department Name: Naistenkeskus (Department of Gyncology)
Principal Investigator Name: Maarit Anttila
Principal Investigator Email: maarit.anttila@pshyvinvointialue.fi
Contact Person Name: Maarit Anttila
Contact Person Email: maarit.anttila@pshyvinvointialue.fi

Site Name: Turku University Hospital
Department Name: Naistentautien poliklinikka (Department of Gyncology)
Principal Investigator Name: Sakari Hietanen
Principal Investigator Email: sakari.hietanen@varha.fi
Contact Person Name: Sakari Hietanen
Contact Person Email: sakari.hietanen@varha.fi

Sponsor

Primary sponsor

Full Name: Tesaro Inc.
Organisation Type: Pharmaceutical company
Country Of Registered Address: United States

Contract research organisations

Name: Icon Clinical Research Limited
Responsibilities: Sponsor-related activities per dossier: sponsorDuties codes [1,12,13,2,5,8]; contact email CTIS-Biotech@iconplc.com

Name: Bioclinica Inc.
Responsibilities: Support services (sponsorDuties code [4]); contact email support@bioclinica.com

Third parties

{"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: [14]; email: help@thermofisher.com","organisation_type":"Pharmaceutical company"}
{"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,12,13,2,5,8]; email: CTIS-Biotech@iconplc.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]; email: pharmaservices@neogenomics.com","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]; email: researchmodels@crl.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: \"sample long term storage\"; email: Service.Products@azenta.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: [14]; email: info@almacgroup.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Myriad Genetics Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: \"HRD testing of tumour tissue\"; email: cscomments@myriad.com","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties codes: [4]; email: indianapolis.cd_tsc@roche.com","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties codes: [15]; value: \"sample long term storage\"; email: Service.Products@azenta.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: \"Dostarlimab PK and NAB testing and analysis\"; email: marketing@frontagelab.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [3,7]; email: Helpdesk@mdsol.com","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: \"Laboratory analysis, Sample storage\"; email: ondemandSupport@labcorp.com","organisation_type":"Pharmaceutical company"}
{"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"sponsorDuties codes: [6]; email: Global.marketing@tcs.com","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [15]; value: \"Histopathology and Digital archiving & filing of pathology reports\"; email: ondemandSupport@labcorp.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [15]; value: \"sample storage\"; email: ondemandSupport@labcorp.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Resolution Bioscience Inc.","duties_or_roles":"sponsorDuties codes: [15,4]; values: \"Biomarker testing, ctDNA HRR testing & analysis\"; email: ido_info@agilent.com","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [4]; email: support@bioclinica.com","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name: JEMPERLI 500 mg concentrate for solution for infusion
Active Substance: DOSTARLIMAB
Modality: Monoclonal antibody
Routes Of Administration: Intravenous
Route: Intravenous
Authorisation Status: Approved (EU MA EU/1/21/1538/001)
Starting Dose: 500 mg
Dose Levels: 500 mg
Frequency: Every 21 days (500 mg after carboplatin infusion on Day 1 of a 21-day cycle, starting Cycle 2)
Maximum Dose: 1000 mg

Investigational Product Name: Niraparib tosilate monohydrate (tablets/capsules)
Active Substance: NIRAPARIB TOSILATE MONOHYDRATE
Modality: Small molecule
Routes Of Administration: Oral
Route: Oral
Authorisation Status: Authorised (UK MIA(IMP) 20377 & IMP12181/00001; PRD references in dossier)
Orphan Designation: Yes
Starting Dose: 300 mg
Dose Levels: 300 mg
Frequency: Daily (maintenance; start delayed at least 6 weeks and up to 9 weeks after Cycle 6 Day 1 to allow hematologic recovery)
Maximum Dose: 300 mg

Investigational Product Name: Placebo (Niraparib placebo tablets, Dostarlimab placebo infusion bags)
Modality: Other

Combination Treatment: Yes

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