Phase
Condition
Ovarian Cysts
Ovarian Cancer
Vaginal Cancer
Treatment
Niraparib
Tuvusertib (M1774)
Lartesertib (M4076)
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed high grade serous or high gradeendometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that isrecurrent.
Participants whose tumor carries germline or somatic deleterious or suspecteddeleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (BreastCancer gene 2), and/or tumors with positive HRD status. The presence of any of thesemutations and/or the homologous recombination deficiency (HRD) status will bedetermined according to routinely used local standard of care tests. Results must beavailable before screening.
Radiologically confirmed/documented disease progression while on Poly (ADP-ribose)polymerase (PARP) inhibitors therapy in either first or second-line maintenancesetting (only 1 line of PARPi maintenance is allowed with or without bevacizumab).Note: Documentation of disease progression must be within 28 days of last PARPi dosetaken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), ANDClinically benefited from PARPi maintenance prior to documented progression, asdefined by at least 6 months of treatment duration with no progressive diseaseobserved, AND either, Progression on first-line maintenance PARPi: Participants areallowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be >6 months, withdocumented disease progression prior to study entry).
OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (that is PARPi is the last treatment before study entry)
Intolerant to standard of care treatment options or refused standard of caretreatment or the participant's treating physician considers that the lack ofstandard of care treatment is not detrimental for the participant.
Measurable disease per RECIST v1.1, as assessed by Investigator.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a lifeexpectancy of at least 6 months.
Other Protocol defined inclusion criteria could apply.
Exclusion
Exclusion Criteria:
Primary platinum-refractory disease defined as disease progression during primaryplatinum-based chemotherapy or platinum-resistant disease defined as diseaseprogression within 6 months of the platinum administration in either the first orsecond-line setting.
History of additional malignancy within 3 years before the date of enrollment.
Known brain metastases, unless clinically stable, that is without evidence ofprogression by imaging for at least 4 weeks prior to the first dose of studyintervention, no evidence of new brain metastases, and on a stable or decreasingdose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for atleast 14 days prior to study intervention administration.
Active and/or uncontrolled infection.
History of known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions.
Organ transplantation, including allogenic stem cell transplant.
Patients with history of drug-induced severe cutaneous adverse reaction (SCAR;including but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], or drug reaction with eosinophilia and systemic symptoms [DRESS]), ordose-limiting immune-mediated reactions related to skin.
Other Protocol defined exclusion criteria could apply.
Study Design
Connect with a study center
Chris O'Brien Lifehouse
Camperdown,
AustraliaSite Not Available
St George Private Hospital
Kogarah,
AustraliaSite Not Available
Liverpool Hospital - PARENT
Liverpool,
AustraliaSite Not Available
Cliniques Universitaires Saint-Luc - STL
Brussels,
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc - STL
Bruxelles, 1200
BelgiumActive - Recruiting
UZ Leuven
Leuven,
BelgiumSite Not Available
Ålborg Universitets Hospital - PARENT
Aalborg,
DenmarkSite Not Available
Rigshospitalet
Copenhagen,
DenmarkSite Not Available
Sjaellands Universitetshospital - other
Odense,
DenmarkSite Not Available
ICO - Site Paul Papin - service d'oncologie medicale
Angers,
FranceSite Not Available
Centre Francois Baclesse - Service d'Oncologie Medicale
Caen,
FranceSite Not Available
Centre Oscar Lambret - service de cancerologie gynecologique
Lille,
FranceSite Not Available
Centre Leon Berard - Service d'Oncologie Medicale
Lyon,
FranceSite Not Available
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale
Paris,
FranceSite Not Available
Hopital Tenon - service d'oncologie medicale
Paris,
FranceSite Not Available
Hôpital Cochin - Hematologie et Oncologie Médicale
Paris,
FranceSite Not Available
Hôpital Européen Georges Pompidou - Hématologie Oncologie
Paris,
FranceSite Not Available
Hôpital Saint Joseph - Paris - Service d'Oncologie-Cancerologie
Paris,
FranceSite Not Available
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale
Paris 2988507,
FranceSite Not Available
Hopital Tenon - service d'oncologie medicale
Paris 2988507,
FranceSite Not Available
Hôpital Cochin - Hematologie et Oncologie Médicale
Paris 2988507,
FranceSite Not Available
Hôpital Saint Joseph - Paris - Service d'Oncologie-Cancerologie
Paris 2988507,
FranceSite Not Available
Centre Hospitalier Lyon Sud - service d'oncologie medicale
Pierre-Bénite,
FranceSite Not Available
Centre de Radiotherapie Clinique Sainte Anne - 300207251
Strasbourg,
FranceSite Not Available
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
Strasbourg,
FranceSite Not Available
Centre de Radiotherapie Clinique Sainte Anne - 300207251
Strasbourg 2973783,
FranceSite Not Available
Institut Gustave Roussy - Oncologie Médicale
Villejuif,
FranceSite Not Available
Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie
Berlin,
GermanySite Not Available
Universitaetsklinikum Bonn AoeR - Frauenklinik
Bonn,
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus TU Dresden - Klinik u. Poliklinik f. Frauenheilkunde
Dresden,
GermanySite Not Available
Kliniken Essen-Mitte - Gynaekologie und Gynaekologische Onkologie
Essen,
GermanySite Not Available
Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde
Leipzig,
GermanySite Not Available
Universitaetsklinikum Muenster - Parent
Münster,
GermanySite Not Available
Universitätsklinikum Münster - Gynecology
Münster,
GermanySite Not Available
Universitaetsklinikum Muenster - Parent
Münster 2867543,
GermanySite Not Available
Caritas-Krankenhaus St. Josef - Klinik fuer Chirurgie
Regensburg,
GermanySite Not Available
Universitaetsklinikum Tuebingen - Parent
Tübingen,
GermanySite Not Available
Rambam Medical Center
Haifa,
IsraelSite Not Available
The Lady Davis Carmel Medical Center
Haifa,
IsraelSite Not Available
The Lady Davis Carmel Medical Center
Haifa 294801,
IsraelSite Not Available
Hadassah University Hospital - Ein Kerem
Jerusalem,
IsraelSite Not Available
Shaare Zedek
Jerusalem,
IsraelSite Not Available
Shaare Zedek
Jerusalem 281184,
IsraelSite Not Available
Chaim Sheba Medical Center
Ramat Gan,
IsraelSite Not Available
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
Bologna,
ItalySite Not Available
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola - SSD Oncologia Medica Zamagni
Bologna,
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
Bologna 3181928,
ItalySite Not Available
Osp Cannizzaro Catania
Catania,
ItalySite Not Available
Azienda Ospedaliero-Universitaria Renato Dulbecco - Centro Oncologico
Catanzaro,
ItalySite Not Available
IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica
Milan,
ItalySite Not Available
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
Milan,
ItalySite Not Available
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
Milan 6951411,
ItalySite Not Available
IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica
Milano,
ItalyActive - Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology
Naples,
ItalySite Not Available
IOV - Istituto Oncologico Veneto IRCCS - Radiologia Oncologica
Padova,
ItalySite Not Available
Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
Roma,
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ostetricia e ginecologia
Rome,
ItalySite Not Available
Catharina Ziekenhuis Eindhoven - Parent
Eindhoven,
NetherlandsSite Not Available
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy - Dept of Chemotherapy
Bydgoszcz,
PolandSite Not Available
Szpitale Pomorskie spó
Gdynia,
PolandSite Not Available
Jagiellonskie Centrum Innowacji Sp. z o.o. - Centrum Bada
Krakow,
PolandSite Not Available
Instytut MSF Sp.z.o.o
Lodz,
PolandSite Not Available
Europejskie Centrum Zdrowia - Oddzial Onkologii
Otwock,
PolandSite Not Available
MICS Centrum Medyczne Torun - Medicovernn
Torun,
PolandSite Not Available
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
Badalona,
SpainSite Not Available
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona,
SpainSite Not Available
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona,
SpainSite Not Available
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona 3128760,
SpainSite Not Available
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
Girona,
SpainSite Not Available
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid,
SpainSite Not Available
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid,
SpainSite Not Available
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid,
SpainSite Not Available
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid 3117735,
SpainSite Not Available
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid 3117735,
SpainSite Not Available
Hospital Regional Universitario de Malaga - Oncology Dept
Málaga,
SpainSite Not Available
Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann
Bellinzona,
SwitzerlandSite Not Available
Kantonsspital Frauenfeld - 150509250
Frauenfeld,
SwitzerlandSite Not Available
Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie
Liestal,
SwitzerlandSite Not Available
Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie
Sankt Gallen,
SwitzerlandSite Not Available
Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie
St. Gallen, 9007
SwitzerlandActive - Recruiting
Universitaetsspital Zuerich - Klinik fuer Gynaekologie
Zuerich, 8091
SwitzerlandActive - Recruiting
Universitaetsspital Zuerich - Klinik fuer Gynaekologie
Zurich,
SwitzerlandSite Not Available
Addenbrooke's Hospital - Dept of Oncology
Cambridge,
United KingdomSite Not Available
Beatson West of Scotland Cancer Centre - Dept of Medical Oncology
Glasgow,
United KingdomSite Not Available
Royal Surrey County Hospital - Dept of Oncology
Guildford,
United KingdomSite Not Available
St James's University Hospital - Dept of Oncology
Leeds,
United KingdomSite Not Available
Guy's Hospital - Dept of Medical Oncology
London,
United KingdomSite Not Available
Royal Marsden Hospital-London - Dept of Haematology/Oncology Research
London,
United KingdomSite Not Available
University College London Hospitals - NIHR/Wellcome Trust
London,
United KingdomSite Not Available
Guy's Hospital - Dept of Medical Oncology
London 2643743,
United KingdomSite Not Available
University College London Hospitals - NIHR/Wellcome Trust
London 2643743,
United KingdomSite Not Available
The Christie Hospital - Dept of Oncology
Manchester,
United KingdomSite Not Available
Mount Vernon Hospital - Dept of Oncology
Northwood,
United KingdomSite Not Available
Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
Sutton,
United KingdomSite Not Available
Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann
Little Rock, Arkansas 72205
United StatesActive - Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
University of California San Francisco - UCSF Medical Center
San Francisco, California 94158
United StatesSite Not Available
Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research
Columbus, Georgia 31904
United StatesSite Not Available
University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion
Chicago, Illinois 60637
United StatesSite Not Available
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME
New York, New York 10029
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Next Oncology - Virginia
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesSite Not Available
Next Oncology - Virginia
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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