BOUQUET Trial - Rare Ovarian Cancers
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. Enrolment will take place in two phases: a preliminary phase followed by a potential expansion phase.
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Trial Identifier: NCT04931342, WO42178, GOG-3051, ENGOT-GYN2
ENGOT Leading Group: GINECO
ENGOT Participating groups: SWISS-GO, AGO, GEICO, A-AGO, BGOG, CEEGOG
Trial description: This is a Phase II, open-label, non-randomized, multicenter, platform study designed to evaluate the efficacy and safety of multiple biomarker-driven treatments in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal tumors of rare epithelial histology.
- low-grade serous carcinoma,
- clear cell carcinoma,
- mucinous carcinoma,
- undifferentiated carcinoma,
- seromucinous carcinoma,
- malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma,
- small cell carcinoma of the ovary, hypercalcemic type).
Information was taken in parts from the Sponsors website.
Aim of the BOUQUET Trial?
This clinical trial is recruiting people who have types of disease called rare epithelial ovarian, fallopian tube or primary peritoneal cancer. All patients must have previously received treatment for their cancer, including at least one platinum-based treatment.
The purpose of this clinical trial is to test the effects, good or bad, of different treatments in patients with different genetic changes (biomarkers) in their cancer.
How does the BOUQUET clinical trial work?
Everyone who joins this clinical trial will have tests to look for different genetic changes, known as biomarkers, in their cancer (biomarker screening). The tests are performed on a small tissue sample taken from the tumour – this is known as a biopsy. After biomarker analysis, not all patients will be able to take part in this clinical trial depending if they have previously received certain other medications or have certain other medical conditions. For each treatment available in this clinical trial, also other specific exclusion criteria that need to be checked carefully by the treating physicians.
This is an open-label clinical trial. This means that both patient and the clinical trial doctor will know which treatment that is being given to the patient. The clinical trial treatment will be given to the patients as long as it can help them. Patients are free to stop this treatment at any time.
What treatments will be given in this clinicla trial?
Once enrolled on the clinical trial, patients will be assigned to one of four groups depending on the biomarkers found. This will determine which treatment they will be given:
- Patients with changes in the PTEN, PIK3CA and/or AKT1 genes will receive ipatasertib, given as a pill once a day on Days 1–21 of a 28-day cycle, plus paclitaxel as an infusion into the vein on Days 1, 8 and 15 of a 28-day cycle. Patients may also be given other medications to reduce the risk of side effects with ipatasertib plus paclitaxel, such as an allergic reaction or diarrhea
- Patients with changes in the BRAF, KRAS, NRAS and/or NF1 genes will receive cobimetinib, given as a pill once a day on Days 1–21 of a 28-day cycle
- Patients with changes in the ERBB2 gene will receive trastuzumab emtansine, given as an infusion into the vein on Day 1 of a 21-day cycle
- Patients with none of the above changes will receive atezolizumab plus bevacizumab, each given as infusions into the vein on Day 1 of a 21-day cycle.
As mentioned, enrolment will take place in two phases: a preliminary phase followed by a potential expansion phase. Approximately 20 patients will be enrolled in each arm during the preliminary phase. If clinical activity is observed in an arm during the preliminary phase, approximately 30 additional patients may be enrolled in that arm during the expansion phase. Arms with minimal clinical activity or unacceptable toxicity will not undergo expansion.
See table 1:
Additional information on the BOUQUET trial such as individual inclusion/exclusion criteria are available on:
This in an international trial with 53 Institutes.
In Switzerland the study is open at Hôpitaux Universitaires de Genève represented by the Swiss GO Trial group (Swiss-GO-04).