Phase
Condition
Ovarian Cancer
Vaginal Cancer
Pelvic 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)
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 last platinum administration in the second-linesetting.
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.
Other Protocol defined exclusion criteria could apply.
Study Design
Connect with a study center
Liverpool Hospital - PARENT
Liverpool,
AustraliaActive - Recruiting
Cliniques Universitaires Saint-Luc - STL
Bruxelles,
BelgiumActive - Recruiting
UZ Leuven
Leuven,
BelgiumActive - Recruiting
Ålborg Universitets Hospital - PARENT
Aalborg,
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen,
DenmarkActive - Recruiting
Sjaellands Universitetshospital - other
Odense,
DenmarkActive - Recruiting
ICO - Site Paul Papin - service d'oncologie medicale
Angers Cedex 2,
FranceActive - Recruiting
Centre Francois Baclesse - Service d'Oncologie Medicale
Caen Cedex 05,
FranceActive - Recruiting
Centre Oscar Lambret - service de cancerologie gynecologique
Lille cedex,
FranceActive - Recruiting
Centre Leon Berard - Service d'Oncologie Medicale
Lyon,
FranceActive - Recruiting
Hôpital Cochin - Hematologie et Oncologie Médicale
Paris,
FranceActive - Recruiting
Hôpital Saint Joseph - Paris - Service d'Oncologie-Cancerologie
Paris Cedex 14,
FranceActive - Recruiting
Hopital Tenon - service d'oncologie medicale
Paris cedex,
FranceActive - Recruiting
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale
Paris cedex 12,
FranceActive - Recruiting
Centre Hospitalier Lyon Sud - service d'oncologie medicale
Pierre Benite cedex,
FranceActive - Recruiting
Centre de Radiotherapie Clinique Sainte Anne - 300207251
Strasbourg,
FranceActive - Recruiting
Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
Strasbourg,
FranceActive - Recruiting
Institut Gustave Roussy - Oncologie Médicale
Villejuif,
FranceActive - Recruiting
Charité - Campus Virchow-Klinikum - Klinik fuer Gynaekologie
Berlin,
GermanyActive - Recruiting
Please Contact the Communication Center
Darmstadt, 64293
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus TU Dresden - Klinik u. Poliklinik f. Frauenheilkunde
Dresden,
GermanyActive - Recruiting
Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Frauenheilkunde
Leipzig,
GermanyActive - Recruiting
Universitaetsklinikum Muenster - Parent
Muenster,
GermanyActive - Recruiting
The Lady Davis Carmel Medical Center
Haifa,
IsraelActive - Recruiting
Hadassah University Hospital - Ein Kerem
Jerusalem,
IsraelActive - Recruiting
Shaare Zedek
Jerusalem,
IsraelActive - Recruiting
Chaim Sheba Medical Center
Ramat Gan,
IsraelActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
Bologna,
ItalyActive - Recruiting
Osp Cannizzaro Catania
Catania,
ItalyActive - Recruiting
IEO Istituto Europeo di Oncologia - Unità Ginecologia Oncologica Medica
Milano,
ItalyActive - Recruiting
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
Milano,
ItalyActive - Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale - Gynecology
Napoli,
ItalyActive - Recruiting
Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A
Roma,
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ostetricia e ginecologia
Rome,
ItalyActive - Recruiting
Szpitale Pomorskie spó
Gdynia,
PolandActive - Recruiting
Jagiellonskie Centrum Innowacji Sp. z o.o. - Centrum Bada
Krakow,
PolandActive - Recruiting
Instytut MSF Sp.z.o.o
Lodz,
PolandActive - Recruiting
Europejskie Centrum Zdrowia - Oddzial Onkologii
Otwock,
PolandActive - Recruiting
MICS Centrum Medyczne Torun - Medicovernn
Torun,
PolandActive - Recruiting
Instytut MSF Sp.z.o.o
Łódź, 90-302
PolandSite Not Available
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona,
SpainActive - Recruiting
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica
Girona,
SpainActive - Recruiting
Clinica Universidad de Navarra (MAD) - Oncology Service
Madrid,
SpainActive - Recruiting
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid,
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid,
SpainActive - Recruiting
Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann
Bellinzona,
SwitzerlandActive - Recruiting
Kantonsspital Frauenfeld - 150509250
Frauenfeld,
SwitzerlandActive - Recruiting
Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie
Liestal,
SwitzerlandActive - Recruiting
Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie
St. Gallen,
SwitzerlandActive - Recruiting
Universitaetsspital Zuerich - Klinik fuer Gynaekologie
Zuerich,
SwitzerlandActive - Recruiting
Royal Surrey County Hospital - Dept of Oncology
Guildford,
United KingdomActive - Recruiting
St James's University Hospital - Dept of Oncology
Leeds,
United KingdomActive - Recruiting
Guy's Hospital - Dept of Medical Oncology
London,
United KingdomActive - Recruiting
University College London Hospitals - NIHR/Wellcome Trust
London,
United KingdomActive - Recruiting
The Christie Hospital - Dept of Oncology
Manchester,
United KingdomActive - Recruiting
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 StatesActive - Recruiting
Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research
Columbus, Georgia 31904
United StatesActive - Recruiting
Please Contact U.S. Medical Information
Rockland, Massachusetts 02370
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesActive - Recruiting
Next Oncology - Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.