BridgeMD
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (BOUQUET)
EU CTIS ID: 2023-508194-89-00
What this study is testing
To evaluate the efficacy of biomarker-driven treatments based on confirmed objective response rate (ORR) as determined by the investigator
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Persistent or recurrent epithelial ovarian cancer (EOC) that meets the following criteria: a) 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 cancer, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma, and small cell carcinoma of the ovary, hypercalcemic type). A primary gastrointestinal carcinoma must have been excluded. b) Disease that is not amenable to curative surgery
- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (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: patients with primary platinum-refractory disease are excluded.
- At the time of prescreening, submission of a representative tumor specimen that is suitable for NGS testing and ER IHC to determine treatment arm assignment and for central pathology review.
You likely can't join if
- 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 (formerly considered tumors of low malignant potential)
- Current diagnosis of non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord-stromal tumors)
- Current diagnosis of synchronous primary endometrial cancer
- Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment
- History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Russian Federation
- Canada
- United Kingdom
- Turkey
- Switzerland
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Russian Federation; Canada; United Kingdom; Turkey and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.