BOUQUET: A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors) Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
Drug: Ipatasertib
Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
Other Names:
Drug: Paclitaxel
Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
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Experimental: Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors) Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
Drug: Cobimetinib
Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)
Other Names:
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Experimental: Trastuzumab Emtansine (ERBB2-amplified/mutant tumors) Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
Drug: Trastuzumab Emtansine
Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Other Names:
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Experimental: Atezolizumab + Bevacizumab (Non-matched) 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. |
Drug: Atezolizumab
Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Other Names:
Drug: Bevacizumab
Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Other Names:
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Experimental: Giredestrant + Abemaciclib (ER+ tumors) 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. |
Drug: Giredestrant
Giredestrant will be administered by mouth once a day during each 28-day cycle
Drug: Abemaciclib
Abemaciclib will be administered by mouth twice a day during each 28-day cycle
Drug: Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.
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Experimental: Inavolisib + Palbociclib (PIK3CA-altered tumors) Participants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
Drug: Inavolisib
Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Drug: Palbociclib
Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle
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Experimental: Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors) Participants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
Drug: Inavolisib
Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Drug: Palbociclib
Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle
Drug: Letrozole
Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Drug: Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.
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Experimental: Inavolisib + Olaparib (Non-matched) Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
Drug: Inavolisib
Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Drug: Olaparib
Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle
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Outcome Measures
Primary Outcome Measures
- Confirmed Objective Response Rate (ORR) [Up to approximately 5 years]
Confirmed ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) (demonstrated on two consecutive occasions >=4 weeks apart), as determined by the investigator according to RECIST v1.1.
Secondary Outcome Measures
- Duration of Response (DOR) [Up to approximately 5 years]
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
- Disease Contral Rate (DCR) [Up to approximately 5 years]
DCR is defined as the proportion of participants with a confirmed CR or PR, or stable disease maintained for at least 16 weeks, as determined by the investigator according to RECIST v1.1.
- Progression Free Survival (PFS) [Up to approximately 5 years]
PFS after start of treatment is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
- 6-Month PFS Rate [Up to 6 month]
6-month PFS rate is defined as the proportion of participants who remained alive and progression-free at 6 months after start of treatment, as determined by the investigator according to RECIST v1.1.
- Overall Survival (OS) [Up to approximately 5 years]
OS after start of treatment is defined as the time from start of treatment to death from any cause.
- Confirmed ORR as Determined by IRC (Independent Review Committee) [Up to approximately 5 years]
Confirmed ORR, as determined by the IRC according to RECIST v1.1.
- DOR as Determined by IRC [Up to approximately 5 years]
DOR, as determined by the IRC according to RECIST v1.1
- DCR as Determined by IRC [Up to approximately 5 years]
DCR, as determined by the IRC according to RECIST v1.1
- PFS as Determined by IRC [Up to approximately 5 years]
PFS, as determined by the IRC according to RECIST v1.1
- Percentage of Participants With Adverse Events [Up to approximately 5 years]
Percentage of participants with adverse events.
- Percentage of Participants With ADA-Positive and ADA-Negative to Atezolizumab [At baseline and after baseline (up to approximately 5 years)]
- Number of Participants With ADA-Positive and ADA-Negative to Atezolizumab [At baseline and after baseline (up to approximately 5 years)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Measurable disease (at least one target lesion) according to RECIST v1.1
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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.
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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.
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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.
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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)
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Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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Adequate hematologic and end-organ function
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For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs (if applicable)
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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:
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Pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study
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Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment
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Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer
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Current diagnosis of solely borderline epithelial ovarian tumor
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Current diagnosis of non-epithelial ovarian tumors
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Current diagnosis of synchronous primary endometrial cancer
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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.
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Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
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Symptomatic, untreated, or actively progressing CNS metastases
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Severe infection within 4 weeks prior to initiation of study treatment
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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
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Treatment with hormonal therapy within 14 days prior to initiation of study treatment
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In addition to the general exclusion criteria above, participants can not meet any of the arm-specific exclusion criteria for the respective arm
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Arizona Oncology - HOPE Wilmot | Tucson | Arizona | United States | 85710 |
2 | Kaiser Permanente - Irvine | Irvine | California | United States | 92618 |
3 | Minnesota Oncology Hematology | Saint Paul | Minnesota | United States | 55102 |
4 | Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology | Saint Louis | Missouri | United States | 63108 |
5 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
6 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
7 | Ohio State University | Columbus | Ohio | United States | 43210 |
8 | University of Oklahoma Health Sciences Center; Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
9 | Northwest Cancer Specialists, P.C. | Tigard | Oregon | United States | 97223 |
10 | Pinnacle Health; Harrisburg Hospital Pharmacy | Harrisburg | Pennsylvania | United States | 17101 |
11 | Magee-Woman's Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
12 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
13 | Texas Oncology - The Woodlands | The Woodlands | Texas | United States | 77380 |
14 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
15 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
16 | University of Washington - Seattle Cancer Care Alliance; Medical Oncology | Seattle | Washington | United States | 98109 |
17 | Cabrini Hospital; Cabrini Foundation | Malvern | Victoria | Australia | 3144 |
18 | UZ Leuven; Gyneacologische Oncologie | Leuven | Belgium | 3000 | |
19 | CHU Sart-Tilman | Liège | Belgium | 4000 | |
20 | Kingston General Hospital | Kingston | Ontario | Canada | K7L 2V7 |
21 | Princess Margaret Cancer Center | Toronto | Ontario | Canada | M5G 1Z5 |
22 | McGill University Health Centre - Glen Site | Montreal | Quebec | Canada | H4A 3J1 |
23 | Fakultni nemocnice Brno Bohunice | Brno | Czechia | 625 00 | |
24 | Gynekologicko-porodnicka klinika | Prague | Czechia | 120 00 | |
25 | CHU Besançon - Hôpital Jean Minjoz | Besançon Cedex | France | 25030 | |
26 | Institut Bergonie; Oncologie | Bordeaux | France | 33076 | |
27 | Centre Francois Baclesse; Oncologie | Caen | France | 14076 | |
28 | CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie | Lyon | France | 69373 | |
29 | Institut Régional du Cancer de Montpellier | Montpellier | France | 34298 | |
30 | Groupe Hospitalier Diaconesses | Paris | France | 75020 | |
31 | Centre Eugène Marquis | Rennes | France | 35042 | |
32 | ICO - Site René Gauducheau | Saint Herblain | France | 44805 | |
33 | Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | France | 31059 | |
34 | Gustave Roussy | Villejuif CEDEX | France | 94800 | |
35 | Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe | Dresden | Germany | 01307 | |
36 | Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie | Essen | Germany | 45136 | |
37 | Universitätsklinikum Mannheim; Frauenklinik | Mannheim | Germany | 68167 | |
38 | Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde | Muenchen | Germany | 81377 | |
39 | Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica | Napoli | Campania | Italy | 80131 |
40 | Policlinico Universitario Agostino Gemelli | Roma | Lazio | Italy | 00168 |
41 | IRCCS S. Raffaele; Ginecologia Oncologica | Milano | Lombardia | Italy | 20132 |
42 | Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica | Milano | Lombardia | Italy | 20141 |
43 | I.R.C.C. Candiolo; Oncologia Medica e Ematologia | Candiolo | Piemonte | Italy | 10060 |
44 | A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica | Bari | Puglia | Italy | 70124 |
45 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
46 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
47 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
48 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
49 | LLC Medscan | Moskva | Moskovskaja Oblast | Russian Federation | 119421 |
50 | FSBI "Federal Medical Research Center n.a. V.A.Almazov" | Sankt-peterburg | Sankt Petersburg | Russian Federation | 197341 |
51 | Chelyabisnk regional clinical center for oncology and nuclear medicine | Chelyabinsk | Sverdlovsk | Russian Federation | 454087 |
52 | Institutio Catalan De Oncologia | Badalona | Barcelona | Spain | 08916 |
53 | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | Spain | 28041 | |
54 | Hospital Universitario La Paz; Servicio de Oncologia | Madrid | Spain | 28046 | |
55 | Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Malaga | Spain | 29010 | |
56 | Hôpitaux Universitaires de Genève; Département d'oncologie | Genève | Switzerland | 1205 | |
57 | Adana Baskent University Medical Faculty; Oncology | Adana | Turkey | 01220 | |
58 | Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü | Ankara | Turkey | 06490 | |
59 | Koc University Medical Faculty; Department of Gynecology & Obstetrics | Istanbul | Turkey | 34010 | |
60 | Western General Hospital; Edinburgh Cancer Center | Edinburgh | United Kingdom | EH4 2XU | |
61 | University College London Hospitals NHS Foundation Trust - University College Hospital | London | United Kingdom | NW1 2PG |
Sponsors and Collaborators
- Hoffmann-La Roche
- GOG Foundation
- European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WO42178
- GOG-3051
- ENGOT-GYN2