Clinical trial • Phase III • Oncology

DOSTARLIMAB for Recurrent endometrial cancer | Advanced endometrial cancer (Stage III/IV)

Phase III trial of DOSTARLIMAB for Recurrent endometrial cancer | Advanced endometrial cancer (Stage III/IV).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Recurrent endometrial cancer | Advanced endometrial cancer (Stage III/IV)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
17-05-2024
First CTIS Authorization Date
12-07-2024

Trial design

Randomised, dostarlimab (tsr-042, jemperli) plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo (part 1). in part 2: dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo. dosing/schedules not specified in the ctis record; routes include iv for dostarlimab and oral for niraparib.-controlled Phase III trial in Greece, Norway, Sweden and others.

Randomised
Yes
Comparator
Dostarlimab (TSR-042, JEMPERLI) plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo (Part 1). In Part 2: dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo. Dosing/schedules not specified in the CTIS record; routes include IV for dostarlimab and oral for niraparib.
Biomarker Stratified
True, biomarker: MMR/MSI status; strata: dMMR/MSI-H and MMRp/MSS
Target Sample Size
560

Stratification factors

  • MMR/MSI status (dMMR/MSI-H vs MMRp/MSS)

Eligibility

Recruits 560 All participants are adult females (≥18 years) and must provide written informed consent. The trial documentation includes country-specific subject information and informed consent forms (including genetic research and pregnancy information). No assent procedures or enrolment of minors are provided (minors are excluded by age criterion)..

Pregnancy Exclusion
(Part 1 and Part 2) 16. Subject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment.
Vulnerable Population
All participants are adult females (≥18 years) and must provide written informed consent. The trial documentation includes country-specific subject information and informed consent forms (including genetic research and pregnancy information). No assent procedures or enrolment of minors are provided (minors are excluded by age criterion).

Inclusion criteria

  • {"criterion_text":"- (Part 1 and Part 2): 1. Female subject at least 18 years of age, who is able to understand the study procedures and agrees to participate in the study by providing written informed consent.\n- (Part 1 and Part 2): 2. Subject has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.\n- (Part 1 and Part 2): 3. Subject must provide adequate tumor tissue sample at Screening for MMR/MSI status testing. Note: The quality of the tumor tissue sample must be confirmed by the central laboratory during screening. Subjects should not be randomized without central laboratory confirmation.\n- (Part 1 and Part 2): 4. Subject must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, and meet at least 1 of the following criteria: a) Subject has primary Stage IIIA to IIIC1 disease with presence of evaluable or measurable disease per RECIST v.1.1 based on Investigator’s assessment. Lesions that are equivocal or can be representative of post-operative change should be biopsied and confirmed for the presence of tumor. b) Subject has primary Stage IIIC1 disease with carcinosarcoma, clear cell, serous, or mixed histology (containing ≥10% carcinosarcoma, clear cell, or serous histology) regardless of presence of evaluable or measurable disease on imaging. c) Subject has primary Stage IIIC2 or Stage IV disease regardless of presence of evaluable or measurable disease. d) Subject has first recurrent disease and is naïve to systemic anticancer therapy. e) Subject has received prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence or PD ≥ 6 months after completing treatment (first recurrence). Note: Subjects with uterine sarcoma are not allowed.\n- (Part 1 and Part 2): 5. Subject has an ECOG performance status of 0 or 1.\n- (Part 1 and Part 2): 6. Subject has adequate organ function, defined as follows: a) Absolute neutrophil count ≥1,500 cells/μL b) Platelets ≥100,000 cells/μL c) Hemoglobin ≥9 g/dL or ≥5.6 mmol/L d) Serum creatinine ≤1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥50 mL/min using the Cockcroft-Gault equation for subjects with creatinine levels >1.5 × institutional ULN e) Total bilirubin ≤1.5× ULN and direct bilirubin ≤1× ULN f) Aspartate aminotransferase and alanine aminotransferase ≤2.5× ULN unless liver metastases are present, in which case they must be ≤5× ULN g) International normalized ratio or prothrombin time (PT) ≤1.5× ULN and activated partial thromboplastin time ≤1.5× ULN. Subjects receiving anticoagulant therapy must have a PT or partial thromboplastin within the therapeutic range of the intended use of anticoagulants.\n- (Part 1 and Part 2): 7. Contraceptive use by subjects should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a) A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • The participant is a woman of nonchildbearing potential. OR • The participant is a WOCBP, using a contraceptive method that is highly effective (with a failure rate of <1% per year and, preferably, with low user dependency) during the Treatment Period and for at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova or oocytes) for the purpose of reproduction during this period. (Note: Duration of contraceptive use may be longer than 180 days in order to comply with local requirements and local approved product labels). Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. The Investigator should evaluate the potential for contraceptive method failure (eg, noncompliance and recently initiated) in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local guidelines) within 72 hours before the first dose of study treatment. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Note: The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Note: Additional requirements for pregnancy testing during and after study treatment are located in (Section 12.2.6.7).\n- Part 2 only: 8. Subjects must have normal BP or adequately treated and controlled hypertension (systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg).\n- Part 2 only: 9. Subjects must be able to take medication PO."}

Exclusion criteria

  • {"criterion_text":"- (Part 1 and Part 2) 1.\tSubject has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and: a.\t has not had a recurrence or PD prior to first dose on the study OR b. has had a recurrence or PD within 6 months of completing anticancer therapy treatment prior to first dose on the study Note: Low-dose cisplatin given as a radiation sensitizer or hormonal therapies do not exclude subjects from study participation.\n- (Part 1 and Part 2) 10.\tSubject 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.\n- (Part 1 and Part 2) 11.\tSubject has not recovered (ie, to Grade ≤1 or to baseline) from cytotoxic therapy-induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within 21 days prior to the first dose of study drug. Note: Subjects with Grade ≤2 neuropathy, Grade ≤2 alopecia, or Grade ≤2 fatigue are an exception to this criterion and may qualify for the study.\n- (Part 1 and Part 2) 12. Subject has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.\n- (Part 1 and Part 2) 13. Subject has a known hypersensitivity to carboplatin, paclitaxel, or dostarlimab components or excipients.\n- (Part 1 and Part 2) 14.\tSubject is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.\n- (Part 1 and Part 2) 15.\tSubject is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, noninfectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).\n- (Part 1 and Part 2) 16.\tSubject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment.\n- (Part 1 and Part 2) 17.\tSubject has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment.\n- Part 2 only: 18.\tSubject has received prior therapy with a PARP inhibitor.\n- Part 2 only: 19.\tSubject has clinically significant cardiovascular disease (eg, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina <6 months to enrollment, New York Heart Association Grade ≥2 congestive heart failure, serious cardiac arrhythmia requiring medication, Grade ≥2 peripheral vascular disease, and history of cerebrovascular accident within 6 months).\n- (Part 1 and Part 2) 2.\tSubject has had >1 recurrence of endometrial cancer.\n- Part 2 only: 20.\tSubject has any known history or current diagnosis of myelodysplastic syndrome or acute myeloid leukemia.\n- Part 2 only: 21.\tSubject is at increased bleeding risk due to concurrent conditions (eg, major injuries or major surgery within the past 28 days prior to start of study treatment, history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).\n- Part 2 only: 22.\tSubject has a known hypersensitivity to niraparib components or excipients.\n- Part 2 only: 23.\tSubject has participated in Part 1 of this study.\n- (Part 1 and Part 2) 3.\tSubject has received prior therapy with an anti-PD-1, anti PD-L1, or anti programmed cell death-ligand 2 agent.\n- (Part 1 and Part 2) 4.\tSubject has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or <5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter. Note: Palliative radiation therapy to a small field ≥1 week prior to Day 1 of study treatment may be allowed.\n- (Part 1 and Part 2) 5.\tSubject has a concomitant malignancy, or subject has a prior non-endometrial invasive malignancy who has been disease-free for <3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.\n- (Part 1 and Part 2) 6.\tSubject has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of PD by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a subject from study participation regardless of clinical stability.\n- (Part 1 and Part 2) 7.\tSubject has a known history of HIV (HIV 1/2 antibodies).\n- (Part 1 and Part 2) 8.\tSubject has known active hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] is detected).\n- (Part 1 and Part 2) 9.\tSubject 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 (eg, thyroid hormone or insulin)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary Endpoints for Part 1: The primary efficacy endpoint of PFS is based on the investigator assessment, which is defined as the time from the date of randomization to the earliest date of radiographic assessment of PD or death by any cause in the absence of PD, whichever occurs first. Tumor response will be evaluated using RECIST v.1.1.","definition_or_measurement_approach":"PFS assessed by Investigator per RECIST v1.1; defined as time from randomization to radiographic PD or death in absence of PD. Tumor response evaluated using RECIST v1.1."}
  • {"endpoint_text":"- Primary Endpoints for Part 1: The primary efficacy endpoint of overall survival is defined as the time from randomization to the date of death by any cause.","definition_or_measurement_approach":"Overall survival defined as time from randomization to date of death from any cause."}
  • {"endpoint_text":"- Primary Endpoint for Part 2: The primary efficacy endpoint of PFS is based on the investigator assessment, which is defined as the time from the date of randomization to the earliest date of radiographic assessment of PD or death by any cause in the absence of PD, whichever occurs first. Tumor response will be evaluated using RECIST v.1.1.","definition_or_measurement_approach":"PFS assessed by Investigator per RECIST v1.1; defined as time from randomization to radiographic PD or death in absence of PD. Tumor response evaluated using RECIST v1.1."}

Secondary endpoints

  • {"endpoint_text":"- 1.\tOS, defined as the time from randomization to the date of death by any cause (Part 2 only).","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause (Part 2)."}
  • {"endpoint_text":"- 2.\tPFS based on BICR assessment, defined as the time from randomization to the earliest date of assessment of PD per RECIST v.1.1 or death by any cause in the absence of PD per RECIST v.1.1, whichever occurs first","definition_or_measurement_approach":"PFS via blinded independent central review (BICR) per RECIST v1.1; time from randomization to PD per RECIST v1.1 or death without PD."}
  • {"endpoint_text":"- 3.\tORR based on BICR and Investigator assessment, defined as the proportion of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR)","definition_or_measurement_approach":"Objective response rate (ORR) measured as proportion with BOR = CR or PR by BICR and Investigator assessments."}
  • {"endpoint_text":"- 4.\tDOR based on BICR and Investigator assessment, defined as the time from the first documentation of CR or PR until the time of the first documentation of subsequent PD per RECIST v.1.1 or death by any cause in the absence of PD per RECIST v.1.1, whichever occurs first","definition_or_measurement_approach":"Duration of response (DOR) measured from first CR/PR documentation until subsequent PD per RECIST v1.1 or death without PD."}
  • {"endpoint_text":"- 5.\tDCR based on BICR and Investigator assessment, defined as the proportion of subjects who have achieved a BOR of CR, PR, or stable disease per RECIST v.1.1","definition_or_measurement_approach":"Disease control rate (DCR) = proportion with BOR of CR, PR or stable disease per RECIST v1.1 (BICR and Investigator)."}
  • {"endpoint_text":"- 6.\tPFS2, defined as the time from treatment randomization to the date of assessment of progression on the first subsequent anticancer therapy following study treatment or death by any cause, whichever is earlier","definition_or_measurement_approach":"PFS2 measured as time from treatment randomization to progression on first subsequent anticancer therapy after study treatment or death, whichever earlier."}
  • {"endpoint_text":"- 7.\tPRO assessment of treatment using EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ EN24","definition_or_measurement_approach":"Patient-reported outcomes (PROs) using EQ-5D-5L, EORTC QLQ-C30 and QLQ-EN24 instruments."}
  • {"endpoint_text":"- 8.\tPK and immunogenicity of dostarlimab (Part 1 and Part 2) and PK of niraparib when administered in combination with dostarlimab (Part 2 only)","definition_or_measurement_approach":"Pharmacokinetics (PK) and immunogenicity assessments for dostarlimab; PK of niraparib when combined with dostarlimab in Part 2."}

Recruitment

Planned Sample Size
560
Recruitment Window Months
88
Consent Approach
Written informed consent required from each participant ('providing written informed consent' per inclusion criterion 1). Participant information and ICF documents provided in country- and language-specific versions (examples in the dossier: Norwegian, Swedish, Hungarian, Polish, Spanish, Italian, Czech, Finnish, Dutch, German, French). Separate ICFs/materials exist for genetic research and pregnancy; no assent procedures are provided (minors are excluded).

Geography

Total Number Of Sites
48
Total Number Of Participants
225

Greece

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
42
Number Of Sites
2
Number Of Participants
1

Sites

Site Name
Euromedica General Clinic Of Thessaloniki
Department Name
2nd Oncology Department
Contact Person Name
George Fountzilas
Contact Person Email
fountzil@auth.gr
Site Name
Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.
Department Name
3rd Gynecologic Oncology Department
Contact Person Name
Ioannis Syrios
Contact Person Email
syriosi@yahoo.gr

Norway

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
35
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Helse Bergen HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Line Bjørge
Contact Person Email
line.bjorge@uib.no
Site Name
St. Olavs Hospital HF
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Guro Aune
Contact Person Email
guro.aune@stolav.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Gyneoncology
Contact Person Name
Anne Gry Bentzen
Contact Person Email
anne.gry.bentzen@unn.no
Site Name
Oslo University Hospital HF
Department Name
Department of Gynaecological Oncology
Contact Person Name
Kristina Lindemann
Contact Person Email
klinde@ous-hf.no

Sweden

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
36
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Karolinska University Hospital
Department Name
Department of Gynaecological Oncology
Contact Person Name
Magnus Frödin-Bolling
Site Name
Uppsala University Hospital
Department Name
Department of Oncology
Contact Person Name
Anthoula Koliadi
Contact Person Email
anthoula.koliadi@akademiska.se

Hungary

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
36
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
University Of Debrecen
Department Name
Szülészeti és Nőgyógyászati Klinika
Contact Person Name
Róbert László Póka
Contact Person Email
pokar@med.unideb.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Szülészeti és Nőgyógyászati Klinika
Contact Person Name
Andrea Bagaméri
Contact Person Email
bagameristudy@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
35
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
UZ Leuven
Department Name
Gynecology – oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical oncology
Contact Person Name
Christine Gennigens
Site Name
Onze-Lieve-Vrouwziekenhuis
Department Name
Oncology
Contact Person Name
Greet Huygh
Contact Person Email
greet.huygh@olvz-aalst.be

Poland

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
35
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Ginekologicznej
Contact Person Name
Beata Maćkowiak-Matejczyk
Contact Person Email
bco@onkologia.bialystok.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
Contact Person Name
Aneta Cymbaluk-Płoska
Contact Person Email
cwbk@pum.edu.pl

Spain

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
12-07-2024
Processing Time Days
32
Number Of Sites
9
Number Of Participants
23

Sites

Site Name
Hospital Universitario Virgen De Valme
Department Name
Medical Oncology
Contact Person Name
Carlos Enrique Robles Barraza
Contact Person Email
croblesbarraza@yahoo.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Contact Person Name
Luis Manso
Contact Person Email
luismansosanchez@gmail.com
Site Name
Hospital Universitario Donostia
Department Name
Medical Oncology
Contact Person Name
Cristina Churruca
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Lydia Gaba
Contact Person Email
lgaba@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Ana Oaknin
Contact Person Email
aoaknin@vhio.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Contact Person Name
José Alejandro Perez Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Medical Oncology
Contact Person Name
Maria Jesús Rubio
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Medical Oncology
Contact Person Name
Maria Jose Bermejo
Contact Person Email
cheberpe@gmail.com
Site Name
Hospital Universitario Donostia (additional site listing)
Department Name
Medical Oncology
Contact Person Name
Cristina Churruca

Italy

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
37
Number Of Sites
8
Number Of Participants
36

Sites

Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
U.O. Oncologia Medica
Contact Person Name
Alessia Caldara
Contact Person Email
alessia.caldara@apss.tn.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica A
Contact Person Name
Antonella Savarese
Contact Person Email
antonella.savarese@ifo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Ginecologia Oncologica
Contact Person Name
Francesco Raspagliesi
Site Name
Azienda Sanitaria Locale Della Provincia Di Biella
Department Name
S.O.C. Oncologia
Contact Person Name
Laura Zavallone
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
UO Oncologia Medica
Contact Person Name
Luigi Carlo Turco
Contact Person Email
luigicarlo.turco@ircc.it
Site Name
Ospedale Di Sassuolo S.p.A.
Department Name
UOSD Oncologia
Contact Person Name
Massimiliano Nicolini
Contact Person Email
m.nicolini@ausl.mo.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico
Department Name
UOC Ginecologia
Contact Person Name
Roberto Angioli
Contact Person Email
r.angioli@policlinicocampus.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
SOC Oncologia
Contact Person Name
Claudia Andreetta

Finland

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
37
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Tampere University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Annika Auranen
Contact Person Email
annika.auranen@pirha.fi
Site Name
Turku University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Sakari Hietanen
Contact Person Email
sakari.hietanen@varha.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Marjo Tuppurainen

Czechia

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
35
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
David Cibula
Contact Person Email
dc@davidcibula.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
Vít Weinberger
Contact Person Email
weinberger.vit@fnbrno.cz

Denmark

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
36
Number Of Sites
5
Number Of Participants
28

Sites

Site Name
Region Sjaelland
Department Name
Klinisk Forskningsenhed
Contact Person Name
Dejan Labudovic
Contact Person Email
dejl@regionsjaelland.dk
Site Name
Rigshospitalet
Department Name
Klinisk Forskningsenhed
Contact Person Name
Trine Jakobi Nøttrup
Site Name
Odense University Hospital
Department Name
Klinisk Forskningsenhed
Contact Person Name
Trine Lembrecht Jørgensen
Contact Person Email
trine.joergensen@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Klinisk Forskningsenhed
Contact Person Name
Nicoline Raaschou-Jensen
Site Name
Aalborg University Hospital
Department Name
Klinisk Forskningsenhed
Contact Person Name
Adam Andrzej Luczak
Contact Person Email
kfeaalborg@rn.dk

Germany

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
35
Number Of Sites
3
Number Of Participants
44

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Katja Rieke
Contact Person Email
Katja.Rieke@uksh.de
Site Name
MVZ fuer Haematologie und Onkologie Ravensburg GmbH
Department Name
Studienzentrum
Contact Person Name
Martina Gropp-Meier
Site Name
Hochtaunus-Kliniken gGmbH
Department Name
Krankenhaus Bad Homburg Frauenklinik
Contact Person Name
Dominik Denschlag

Netherlands

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
35
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Catharina Ziekenhuis Stichting
Department Name
Medical oncology
Contact Person Name
Anna Marie Thijs
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Internal Medicine, section Medical Oncology
Contact Person Name
A . J. M. (Tonneke ) Beijers
Contact Person Email
tonneke.beijers@mumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Contact Person Name
Ingrid Boere
Contact Person Email
i.boere@erasmusmc.nl

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon
Responsibilities
Monitoring, Regulatory (e.g. preparation of applications to CA and ethics committee), Investigator recruitment, SUSAR reporting, Statistical analysis, Project management, Data Monitoring Committee, Programming, Medical Management
Name
Labcorp Central Laboratory Services SARL
Responsibilities
ctDNA testing, blood sample DNA extraction, Digital archiving & filing of pathology reports
Name
Frontage Laboratories Inc.
Responsibilities
NAB analysis
Name
Charles River Laboratories Inc.
Responsibilities
laboratory services (sponsor duties code 4)

Third parties

  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Long term sample storage post-study/drug approval","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"ctDNA testing, blood sample DNA extraction, Digital archiving & filing of pathology reports; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"NAB analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"Medical review and case processing","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Icon","duties_or_roles":"Monitoring, Regulatory (e.g. preparation of applications to CA and ethics committee), Investigator recruitment, SUSAR reporting, Statistical analysis, Project management, Data Monitoring Committee, Programming, Medical Management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
JEMPERLI 500 mg concentrate for solution for infusion
Active Substance
DOSTARLIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous use
Route
Intravenous
Authorisation Status
Authorised (prodAuthStatus 2)
Maximum Dose
1000 mg (maxDailyDoseAmount)
Investigational Product Name
NIRAPARIB (tablets/capsules)
Active Substance
NIRAPARIB TOSILATE MONOHYDRATE
Modality
Small molecule
Routes Of Administration
Oral use
Route
Oral
Authorisation Status
Authorised (prodAuthStatus 1)
Maximum Dose
300 mg (maxDailyDoseAmount)
Combination Treatment
Yes

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