BOUQUET: A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04931342
Collaborator
GOG Foundation (Other), European Network of Gynaecological Oncological Trial Groups (ENGOT) (Other)
400
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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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Actual Study Start Date :
Oct 7, 2021
Anticipated Primary Completion Date :
Aug 15, 2024
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
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:
  • RO5532961
  • Drug: Paclitaxel
    Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)

    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:
  • RO5514041
  • 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:
  • RO5304020
  • 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:
  • RO5541267, Tecentriq
  • Drug: Bevacizumab
    Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
    Other Names:
  • RO4876646, Avastin
  • 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.

    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

    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.

    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. DOR as Determined by IRC [Up to approximately 5 years]

      DOR, as determined by the IRC according to RECIST v1.1

    8. DCR as Determined by IRC [Up to approximately 5 years]

      DCR, as determined by the IRC according to RECIST v1.1

    9. PFS as Determined by IRC [Up to approximately 5 years]

      PFS, as determined by the IRC according to RECIST v1.1

    10. Percentage of Participants With Adverse Events [Up to approximately 5 years]

      Percentage of participants with adverse events.

    11. Percentage of Participants With ADA-Positive and ADA-Negative to Atezolizumab [At baseline and after baseline (up to approximately 5 years)]

    12. Number of Participants With ADA-Positive and ADA-Negative to Atezolizumab [At baseline and after baseline (up to approximately 5 years)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04931342
    Other Study ID Numbers:
    • WO42178
    • GOG-3051
    • ENGOT-GYN2
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022