Clinical trial • Phase III • Oncology

SACITUZUMAB GOVITECAN for Triple-negative breast cancer (metastatic, PD-L1 positive)

Phase III trial of SACITUZUMAB GOVITECAN for Triple-negative breast cancer (metastatic, PD-L1 positive).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple-negative breast cancer (metastatic, PD-L1 positive)
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
27-09-2024
First CTIS Authorization Date
04-11-2024

Trial design

Randomised, open-label, treatment of physician's choice (tpc): investigator's choice chemotherapy options include gemcitabine (gemcitabine 38 mg/ml concentrate for infusion; dosing unit mg/m2; max daily amount listed 1000 mg/m2), carboplatin (carboplatin 10 mg/ml; dosing mg/m2; max listed 1000 mg/m2), paclitaxel (paclitaxel 6 mg/ml; dosing mg/m2; max listed 90 mg/m2), or nab-paclitaxel (abraxane; max listed 100 mg/m2). in both arms pembrolizumab (keytruda 25 mg/ml concentrate for infusion; pembrolizumab listed, max amount 200 mg) is administered. specific schedules are not specified in the provided record.-controlled Phase III trial in Netherlands, Hungary, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment of Physician's Choice (TPC): investigator's choice chemotherapy options include Gemcitabine (Gemcitabine 38 mg/mL concentrate for infusion; dosing unit mg/m2; max daily amount listed 1000 mg/m2), Carboplatin (Carboplatin 10 mg/mL; dosing mg/m2; max listed 1000 mg/m2), Paclitaxel (Paclitaxel 6 mg/mL; dosing mg/m2; max listed 90 mg/m2), or Nab-paclitaxel (Abraxane; max listed 100 mg/m2). In both arms pembrolizumab (KEYTRUDA 25 mg/mL concentrate for infusion; pembrolizumab listed, max amount 200 mg) is administered. Specific schedules are not specified in the provided record.
Target Sample Size
329

Eligibility

Recruits 329 Participants must be 18 years of age or older and able to understand and give written informed consent. Informed consent is to be provided by participants (written ICF). Subject information and ICF documents (including partner pregnancy follow-up and pre-screening materials) are provided in local languages for participating countries. Minors are not eligible, and no assent procedures for children are described..

Pregnancy Exclusion
Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study (no waivers for participant eligibility will be offered or permitted): Positive serum pregnancy test (Appendix 11.4) or women who are lactating.
Vulnerable Population
Participants must be 18 years of age or older and able to understand and give written informed consent. Informed consent is to be provided by participants (written ICF). Subject information and ICF documents (including partner pregnancy follow-up and pre-screening materials) are provided in local languages for participating countries. Minors are not eligible, and no assent procedures for children are described.

Inclusion criteria

  • {"criterion_text":"- Participants must meet all of the following inclusion criteria to be eligible for participation in this study (no waivers for participant eligibility will be offered or permitted): Female or male participants, regardless of race and/or ethnic group, who are 18 years of age or older, able to understand and give written informed consent.\n- International normalized ratio (INR)/PT and PTT or aPTT ≤ 1.5 ULN unless participant is currently receiving therapeutic anticoagulant therapy.\n- Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 11.4.\n- Participants with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease defined as: a) Participants on ART must have a CD4+ T-cell count ≥ 350 cells/mm3 at time of screening. b) Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening. c) Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (Day 1). d) The combination ART regimen must not contain any medications that may interfere with SN-38 metabolism\n- Participants with locally advanced inoperable or metastatic TNBC who have not received previous systemic therapy for advanced disease and whose tumors are PD-L1 positive at screening. a) Participants must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent (eg, date of primary breast cancer surgery or date of last (neo)adjuvant chemotherapy administration [including anti-PD-(L)1 treatment], whichever occurred last) and first documented local or distant disease recurrence. Dates of postoperative radiotherapy are not included in this calculation. Prior use of an anti-PD(L)1 agent in the curative TNBC setting is permitted. i) Participants who received taxane, gemcitabine, or platinum agents in the (neo)adjuvant setting can be treated with same class of chemotherapy (taxane or gemcitabine/carboplatin) if ≥ 12 months have elapsed between the completion of treatment with curative intent (eg, date of primary breast tumor surgery or date of last (neo)adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence. ii) Participants enrolled should have received prior anthracycline in the (neo)adjuvant setting or be considered not eligible for anthracyclines as assessed by the treating physician. b) Participants presenting with de novo metastatic TNBC are eligible for this study. c) TNBC status and tumor PD-L1 CPS will be confirmed centrally on a recent or archival tumor specimen. Participants must have histologically or cytologically documented TNBC, according to current ASCO/CAP criteria, defined as negative for ER, progesterone receptor, and HER2 {Allison 2020, Wolff 2018}. Participants initially diagnosed with hormone receptor-positive or HER2-positive breast cancer must have central confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site prior to study entry. Tumor CPS ≥ 10 using the PD-L1 IHC 22C3 assay will be required for eligibility. d) Participants must have measurable disease by CT or MRI as per RECIST Version 1.1 criteria (Appendix 11.7) as evaluated locally. Tumor lesions situated in a previously irradiated area are considered measurable if unequivocal progression has been documented in such lesions since radiation.\n- Have provided representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in blocks (preferably) or have at least 20 to 25 freshly sectioned unstained slides from fresh biopsy tissue (preferred) or archival tissue block for central testing of ER, progesterone receptor, HER2, PD-L1, Trop-2, and additional biomarker testing. A baseline biopsy is required if archival tissue is not available and this procedure must be performed prior to the first dose of study treatment and after the participant provides written informed consent. Fine needle aspirates and bone biopsies are not suitable samples. Note: Tumor tissue quality must be confirmed by the central laboratory. Submission of another tumor specimen may be required if provided specimen is not adequate for assessment. A discussion with the medical monitor is required if only 15 to 19 unstained slides are available and it is not clinically feasible to obtain a new biopsy.\n- ECOG performance status score of 0 or 1 (Appendix 11.6).\n- Life expectancy ≥ 3 months.\n- Recovered from major surgery for ≥ 2 weeks.\n- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study treatment initiations (hemoglobin ≥ 9 g/dL, ANC ≥ 1500/mm3, and platelets ≥ 100,000/μL).\n- Adequate hepatic function (bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN or ≤ 5 × ULN if known liver metastases, and serum albumin > 3 g/dL).\n- Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976}."}

Exclusion criteria

  • {"criterion_text":"- Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study (no waivers for participant eligibility will be offered or permitted): Positive serum pregnancy test (Appendix 11.4) or women who are lactating.\n- Have undergone an allogenic tissue or solid organ transplant.\n- Met any of the following criteria for cardiac disease: a) Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. c) New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of < 40%.\n- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or GI perforation within 6 months of enrollment.\n- Have active serious infection requiring systemic antimicrobial therapy.\n- Participants positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.\n- Have active HBV (defined as having a positive HBsAg test) or HCV. a) For participants with a history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the participant may be eligible. b) Participants who are HCV antibody positive with undetectable HCV viral load may be eligible.\n- Have other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n- Has a diagnosis of immunodeficiency or receiving systemic corticosteroid therapy (higher than physiologic doses) ≥ 10 mg of prednisone per day or equivalent] or any other form of immunosuppressive therapy within 14 days prior to randomization.\n- Has received a live or live-attenuated vaccine within 30 days prior to randomization. Administration of killed vaccines are allowed.\n- Has an active autoimmune disease that has required systemic treatment in the past 2 years (eg, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n- Known or severe (≥ Grade 3) hypersensitivity or allergy to SG, pembrolizumab, and/or the chemotherapy regimen of choice in the TPC arm (eg, nab-paclitaxel, paclitaxel, gemcitabine, or carboplatin), their metabolites, or formulation excipient.\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (2 weeks of radiotherapy) to non-CNS disease.\n- Have received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n- Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.6.1.\n- Participants may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. Participants must have recovered from AEs due to a previously administered agent to ≤ Grade 1 or baseline at the time of study entry. Note: participants with ≤ Grade 2 neuropathy or any grade alopecia are an exception to this criterion and will qualify for the study. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible. Note: if participants received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.\n- Participants may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Participants participating in observational studies are eligible.\n- Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.\n- Have an active second malignancy. Note: participants with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n- Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate (with the exception of those treated with chemotherapy) provided they have stable CNS disease (defined as radiographic stability demonstrated with a minimum of 2 post-treatment brain imaging assessments; one performed during screening) for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and have also been clinically stable for at least 2 weeks while taking ≤ 10 mg/day of prednisone or its equivalent. All participants with carcinomatous meningitis are excluded regardless of clinical stability."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per RECIST Version 1.1, or death (whichever comes first)","definition_or_measurement_approach":"PFS assessed by Blinded Independent Central Review (BICR) using RECIST Version 1.1; time from randomization to objective PD or death."}

Secondary endpoints

  • {"endpoint_text":"- OS is defined as the time from the date of randomization until death due to any cause.","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause."}
  • {"endpoint_text":"- ORR is defined as the proportion of participants who achieve CR or PR that is confirmed at least 4 weeks after initial documentation of response as assessed by BICR per RECIST Version 1.1.","definition_or_measurement_approach":"Objective Response Rate assessed by BICR per RECIST v1.1; CR or PR confirmed ≥4 weeks after initial documentation."}
  • {"endpoint_text":"- DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first) as assessed by BICR per RECIST Version 1.1.","definition_or_measurement_approach":"Duration of Response measured from first CR/PR to objective PD or death per BICR RECIST v1.1."}
  • {"endpoint_text":"- TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR per RECIST Version 1.1.","definition_or_measurement_approach":"Time to Response assessed by BICR per RECIST v1.1 (time from randomization to first documented CR or PR)."}
  • {"endpoint_text":"- Incidence of TEAEs and clinical laboratory abnormalities.","definition_or_measurement_approach":"Safety assessed by incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities (standard AE reporting)."}
  • {"endpoint_text":"- TTD of physical functioning domain of the EORTC QLQ-C30.","definition_or_measurement_approach":"Time to deterioration in physical functioning measured by EORTC QLQ-C30 (Version 3.0)."}
  • {"endpoint_text":"- TTD of role functioning, global health status/QOL, pain, and fatigue subscale domains of the EORTC QLQ-C30.","definition_or_measurement_approach":"Time to deterioration in role functioning, global health status/QOL, pain and fatigue measured by EORTC QLQ-C30 (Version 3.0) subscales."}

Recruitment

Planned Sample Size
329
Recruitment Window Months
53
Consent Approach
Written informed consent must be provided by each participant (participants must be ≥18 years and able to understand and give written informed consent). Subject information and ICF documents (main ICF, pre-screening ICF, crossover ICF where applicable, partner pregnancy follow-up, biomarker/genetic testing ICFs, and other subject materials) are available in local languages for participating countries (examples: Dutch, Hungarian, German, Italian, French, Spanish, Polish, Czech). No assent for minors is applicable since minors are excluded.

Geography

Total Number Of Sites
56
Total Number Of Participants
114

Netherlands

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
531
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Amphia Hospital
Department Name
Oncology
Contact Person Name
Joan Heijns
Contact Person Email
jheijns@amphia.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Medical Oncology
Contact Person Name
Janine Nuver
Contact Person Email
j.nuver@umcg.nl
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Oncology center Leeuwarden
Contact Person Name
Lisanne Hamming
Contact Person Email
lisanne.hamming@mcl.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Oncology
Contact Person Name
Agnes Jager
Contact Person Email
a.jager@erasmusmc.nl

Hungary

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
533
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Chemotherapy “B”
Contact Person Name
Gábor László Rubovszky
Contact Person Email
rubovszky.gabor@oncol.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Department of Oncoradiology
Contact Person Name
Andras Szigeti
Contact Person Email
drszigetia.petz@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
531
Number Of Sites
9
Number Of Participants
19

Sites

Site Name
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department Name
Oncology Division
Contact Person Name
Editta Baldini
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Breast Oncology Division
Contact Person Name
Michelino De Laurentiis
Contact Person Email
delauren@unina.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOS DI DIPARTIMENTO Medicina di Precisione in Senologia
Contact Person Name
Alessandra Fabi
Site Name
Azienda USL Toscana Centro
Department Name
Oncology Unit
Contact Person Name
Laura Biganzoli
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
SSD Oncologia
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UO Oncologia
Contact Person Name
Rebecca Pedersini
Contact Person Email
rebecca.pedersini@gmail.com
Site Name
Istituto Oncologico Veneto
Department Name
U.O.C. Oncologia Medica 2 I
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dep. Medical Oncology 1
Contact Person Name
Giulia Bianchi
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Division of Medical Senoloy
Contact Person Name
Marco Colleoni
Contact Person Email
marco.colleoni@ieo.it

France

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
530
Number Of Sites
11
Number Of Participants
25

Sites

Site Name
Centre Francois Baclesse
Department Name
Medical Oncology
Contact Person Name
Christelle Levy
Contact Person Email
C.LEVY@baclesse.unicancer.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Medical Oncology
Contact Person Name
Cristian Villanueva
Contact Person Email
villanueva@ccgm.fr
Site Name
Centre Jean Perrin
Department Name
Medical Oncology
Contact Person Name
Marie-Ange Mouret-Reynier
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Olivier Tredan
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Nelly Firmin
Contact Person Email
Nelly.Firmin@icm.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Barbara Pistilli
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Medical Oncology
Contact Person Name
Florence Dalenc
Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology
Contact Person Name
Frederic Viret
Contact Person Email
viretf@ipc.unicancer.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Medical Oncology
Contact Person Name
Alain Lortholary
Site Name
Polyclinique Bordeaux Nord Aquitaine
Department Name
Medical Oncology
Contact Person Name
Nadine Dohollou
Contact Person Email
n.dohollou@bordeauxnord.com
Site Name
CHU Besancon
Department Name
Medical Oncology
Contact Person Name
Laura Mansi
Contact Person Email
lmansi@chu-besancon.fr

Germany

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
532
Number Of Sites
7
Number Of Participants
11

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Gynecology
Contact Person Name
Volkmar Müller
Contact Person Email
v.mueller@uke.de
Site Name
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Department Name
Breast Center
Contact Person Name
Oleg Gluz
Site Name
Knappschaft Kliniken Bottrop GmbH
Department Name
Clinic for Gynecology and Obstetrics
Contact Person Name
Hans-Christian Kolberg
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department for Women’s Health, University Hospital Tubingen
Contact Person Name
Tobias Engler
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Department of Gynecology and Obstetrics
Contact Person Name
Maggie Banys-Paluchowski
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Oncology Day Clinic and Study Center at the Women's Clinic in Taxisstraße / Rotkreuzklinikum Munich
Contact Person Name
Claus Hanusch
Contact Person Email
claus.hanusch@swmbrk.de
Site Name
University Hospital Cologne AöR
Department Name
Breast Center Cologne / Frechen in the Department of Obstetrics and Gynecology
Contact Person Name
Wolfram Malter
Contact Person Email
wolfram.malter@uk-koeln.de

Spain

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
532
Number Of Sites
13
Number Of Participants
32

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Cristina Reboredo Rendo
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Maria Vidal
Contact Person Email
mjvidal@clinic.cat
Site Name
Hospital General Universitario Morales Meseguer
Department Name
Hematology/ Oncology
Contact Person Name
Elisa Garcia Garre
Contact Person Email
eliggarre3@yahoo.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Cristina Arqueros Nunez
Contact Person Email
carqueros@santpau.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Breast Cancer Group
Contact Person Name
Mafalda Oliveira
Contact Person Email
moliveira@vhio.net
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Medical Oncology
Contact Person Name
Serafin Morales Murillo
Contact Person Email
serafinmorales01@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Medical Oncology
Contact Person Name
Javier Pascual
Contact Person Email
javpaslop@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Contact Person Name
Sara Lopez-Tarruella
Contact Person Email
slopeztarruella@gmail.com
Site Name
MD Anderson Cancer Center
Department Name
Breast Cancer Unit
Contact Person Name
Laura Garcia Estevez
Contact Person Email
lgestevez@mdanderson.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Begoña Bermejo De Las Heras
Contact Person Email
bermejo_beg@gva.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Yann Izarzugaza Peron
Contact Person Email
yizarzugaza@fjd.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Contact Person Name
Javier Salvador Bofill
Contact Person Email
jsalvad2002@yahoo.es
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Contact Person Name
Javier Cortés Castán
Contact Person Email
javier.cortes@maj3.health

Czechia

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
531
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologicka klinika
Contact Person Name
Martina Zimovjanová
Contact Person Email
martina.zimovjanova@vfn.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Radioterapeutická a onkologická klinika
Contact Person Name
Renata Soumarová
Contact Person Email
renata.soumarova@fnkv.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Contact Person Name
Katarína Petráková
Contact Person Email
petrakova@mou.cz

Poland

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
532
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Piersi i Chrirurgii Rekonstrukcyjnej
Contact Person Name
Zbigniew Nowecki
Contact Person Email
zbigniew.nowecki@nio.gov.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Jacek Jassem
Contact Person Email
jjassem@gumed.edu.pl
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Contact Person Name
Barbara Radecka
Contact Person Email
brad@onkologia.opole.pl

Austria

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
533
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Daniel Egle
Contact Person Email
daniel.egle@tirol-kliniken.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Hematooncology
Contact Person Name
Clemens Dormann

Belgium

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
532
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Eline Naert
Contact Person Email
eline.naert@uzgent.be
Site Name
UZ Leuven
Department Name
Department of General Medical Oncology
Contact Person Name
Hans Wildiers
Contact Person Email
hans.wildiers@uzleuven.be

Sponsor

Primary sponsor

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

Contract research organisations

Name
Signant Health Global LLC
Responsibilities
sponsorDuties code 5
Name
Bioclinica Inc.
Responsibilities
sponsorDuties code 5

Third parties

  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties code 5","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code 5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code 5","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Signant Health Global LLC (Blue Bell address)","duties_or_roles":"sponsorDuties code 5","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Trodelvy 200 mg powder for concentrate for solution for infusion
Active Substance
SACITUZUMAB GOVITECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus 2)
Maximum Dose
10 mg/kg
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus 2)
Maximum Dose
200 mg
Investigational Product Name
Gemcitabine 38 mg/mL concentrate for solution for infusion
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus 2)
Maximum Dose
1000 mg/m2
Investigational Product Name
Carboplatin 10 mg/ml concentrate for solution for infusion
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus 2)
Maximum Dose
1000 mg/m2
Investigational Product Name
Paclitaxel 6 mg/ml concentrate for solution for infusion
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus 2)
Maximum Dose
90 mg/m2
Investigational Product Name
Abraxane 5 mg/ml powder for dispersion for infusion.
Active Substance
PACLITAXEL ALBUMIN-BOUND
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus 2)
Maximum Dose
100 mg/m2
Combination Treatment
Yes

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