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RecruitingLast updated: 2 February 2024

BOUQUET: This phase II study is evaluating how safe and effective multiple biomarker-selected treatments are in people with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal cancer.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

Clinical summary

Summary

Eligible participants will be assigned to one of eight experimental arms based on the biomarkers of their cancer. In Experimental Arm A (PIK3CA/AKT1/PTEN-altered cancers), participants will receive Ipatasertib (administered orally once a day on Days 1-21 of each 28-day cycle) + Paclitaxel (administered intravenously on Days 1, 8, and 15 of each 28-day cycle). In Experimental Am B (BRAF/NRAS/KRAS/NF1-altered cancers), participants will receive cobimetinib (administered orally once a day on Days 1-21 of each 28-day cycle). In Experimental Arm C (ERBB2-amplified/mutant cancers), participants will receive Trastuzumab Emtansine (administered intravenously on Day 1 of each 21-day cycle). In Experimental Arm D (non-matched), participants will receive Atezolizumab (administered intravenously on Day 1 of each 21-day cycle) + Bevacizumab (administered intravenously on Day 1 of each 21-day cycle). In Experimental Arm E (ER+ cancers), participants will receive Giredestrant (administered orally once a day during each 28-day cycle) + Abemaciclib (administered orally twice a day during each 28-day cycle) + (if applicable) Luteinizing Hormone-Releasing Hormone (LHRH) Agonists (required to begin at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women). In Experimental Arm F (PIK3CA-altered cancers), participants will receive Inavolisib (administered orally once a day on Days 1-28 of each 28-day cycle) + Palbociclib (administered orally once a day on Days 1-21 of each 28-day cycle). In Experimental Arm G (ER+ and PIK3CA-altered cancers), participants will receive Inavolisib (administered orally once a day on Days 1-21 of each 28-day cycle) + Palbociclib (administered orally once a day on Days 1-21 of each 28-day cycle) + Letrozole (administered orally once a day on Days 1-28 of each 28-day cycle) + (if applicable) Luteinizing Hormone-Releasing Hormone (LHRH) Agonists (required to begin at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women). In Experimental Arm H (non-matched), participants will receive Inavolisib (administered by mouth once a day on Days 1-28 of each 28-day cycle + Olaparib (administered by mouth twice a day on Days 1-28 of each 28-day cycle).

Conditions

This trial is treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

II

Trial Acronym

BOUQUET

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche,European Network of Gynaecological Oncological Trial Groups (ENGOT)

Scientific 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

Eligibility

Inclusion

  • 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

Exclusion

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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