A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (BOUQUET)
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- Persistent or recurrent EOC that meets the following criteria: Histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, including but not limited to low-grade serous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, seromucinous carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma and small cell carcinoma of the ovary, hypercalcemic type (SCCOHT). Disease that is not amenable to curative surgery
- Measurable disease (at least one target lesion) according to RECIST v1.1
- Previous treatment with one to four lines of therapy, at least one of which was platinum-based. Hormonal therapy does not count as a line of therapy.
- Platinum-resistant disease, defined as disease progression during or within 6 months of last platinum therapy, with the following exception: Participants with primary platinum-refractory disease are excluded.
- Submission of a representative tumor specimen that is suitable for next-generation sequencing (NGS) testing and estrogen receptor immunohistochemistry (ER IHC) to determine treatment arm assignment and for central pathology review.
- Submission of the local pathology report and, if available, any associated stained slides that supported the local diagnosis of the histology (to be used for central pathology review)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs (if applicable)
- In addition to the general inclusion criteria above, participants must meet all of the arm-specific inclusion criteria for the respective arm
General Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study
- Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment
- Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer
- Current diagnosis of solely borderline epithelial ovarian tumor
- Current diagnosis of non-epithelial ovarian tumors
- Current diagnosis of synchronous primary endometrial cancer
- Prior history of primary endometrial cancer, with the following exception: a prior diagnosis of primary endometrial cancer is permitted if it meets all of the following conditions: Stage IA, no lymphovascular invasion, International Federation of Gynecology and Obstetrics Grade 1 or 2, not a high-grade subtype.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Symptomatic, untreated, or actively progressing CNS metastases
- Severe infection within 4 weeks prior to initiation of study treatment
- Treatment with chemotherapy, radiotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or investigational therapy within 28 days prior to initiation of study treatment
- Treatment with hormonal therapy within 14 days prior to initiation of study treatment
- In addition to the general exclusion criteria above, participants can not meet any of the arm-specific exclusion criteria for the respective arm
Sites / Locations
- Arizona Oncology - HOPE WilmotRecruiting
- Kaiser Permanente - IrvineRecruiting
- UCSF Helen Diller Family CCCRecruiting
- Minnesota Oncology HematologyRecruiting
- Washington University School of Medicine; Dept of Medicine/Div of Medical OncologyRecruiting
- Memorial Sloan Kettering Cancer Center
- Levine Cancer InstituteRecruiting
- Ohio State UniversityRecruiting
- University of Oklahoma Health Sciences Center; Stephenson Cancer CenterRecruiting
- Northwest Cancer Specialists, P.C.Recruiting
- Pinnacle Health; Harrisburg Hospital PharmacyRecruiting
- Magee-Woman's HospitalRecruiting
- MD Anderson Cancer CenterRecruiting
- Texas Oncology - Gulf CoastRecruiting
- Huntsman Cancer InstituteRecruiting
- Virginia Oncology AssociatesRecruiting
- University of Washington - Seattle Cancer Care Alliance; Medical OncologyRecruiting
- Cabrini Hospital; Cabrini FoundationRecruiting
- UZ Leuven; Gyneacologische OncologieRecruiting
- CHU Sart-TilmanRecruiting
- Kingston General HospitalRecruiting
- Princess Margaret Cancer CenterRecruiting
- McGill University Health Centre - Glen SiteRecruiting
- Fakultni nemocnice Brno BohuniceRecruiting
- Gynekologicko-porodnicka klinikaRecruiting
- CHU Besançon - Hôpital Jean Minjoz
- Institut Bergonie; OncologieRecruiting
- Centre Francois Baclesse; OncologieRecruiting
- CENTRE LEON BERARD; Département d?Hématologie et d?OncologieRecruiting
- Institut Régional du Cancer de MontpellierRecruiting
- Groupe Hospitalier DiaconessesRecruiting
- Centre Eugène MarquisRecruiting
- ICO - Site René GauducheauRecruiting
- Institut Claudius Regaud; Departement Oncologie MedicaleRecruiting
- Gustave RoussyRecruiting
- Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und GeburtshilfeRecruiting
- Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
- Universitätsklinikum Mannheim; FrauenklinikRecruiting
- Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für FrauenheilkundeRecruiting
- Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-GinecologicaRecruiting
- Policlinico Universitario Agostino GemelliRecruiting
- IRCCS S. Raffaele; Ginecologia OncologicaRecruiting
- Irccs Istituto Europeo Di Oncologia (IEO); Oncologia MedicaRecruiting
- I.R.C.C. Candiolo; Oncologia Medica e EmatologiaRecruiting
- A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- LLC MedscanRecruiting
- FSBI "Federal Medical Research Center n.a. V.A.Almazov"
- Chelyabisnk regional clinical center for oncology and nuclear medicineRecruiting
- Institutio Catalan De OncologiaRecruiting
- Hospital Universitario 12 de Octubre; Servicio de OncologiaRecruiting
- Hospital Universitario La Paz; Servicio de OncologiaRecruiting
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
- Hôpitaux Universitaires de Genève; Département d'oncologieRecruiting
- Adana Baskent University Medical Faculty; Oncology
- Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji BölümüRecruiting
- Koc University Medical Faculty; Department of Gynecology & ObstetricsRecruiting
- Western General Hospital; Edinburgh Cancer CenterRecruiting
- University College London Hospitals NHS Foundation Trust - University College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors)
Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors)
Trastuzumab Emtansine (ERBB2-amplified/mutant tumors)
Atezolizumab + Bevacizumab (Non-matched)
Giredestrant + Abemaciclib (ER+ tumors)
Inavolisib + Palbociclib (PIK3CA-altered tumors)
Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors)
Inavolisib + Olaparib (Non-matched)
Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors)
Inavolisib + Bevacizumab (PIK3CA-altered tumors)
Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched)
Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Participants in the Atezolizumab + Bevacizumab arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Participants in the Giredestrant + Abemaciclib arm will receive treatment until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Participants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Participants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Participants in the Inavolisib + Giredestrant arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Participants in the Inavolisib + Bevacizumab arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Participants in the Atezolizumab + Bevacizumab + Cyclophosphamide arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.