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A clinical trial to look at the effects of different treatments on rare types of previously treated epithelial ovarian, fallopian tube or primary peritoneal cancers with different genetic changes
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
- Ovarian Cancer
Trial Status:
Recruiting
This trial runs in
Countries
- Australia
- Belgium
- Canada
- Czechia
- France
- Germany
- Italy
- Russia
- South Korea
- Spain
- Switzerland
- Turkey
- United Kingdom
- United States
Trial Identifier:
NCT04931342 GOG-3051, ENGOT-GYN2 WO42178
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT04931342 , WO42178 , GOG-3051, ENGOT-GYN2
Trial Identifier
Female
Gender
≥18 Years
Age
No
Healthy Volunteers
How does the BOUQUET clinical trial work?
This clinical trial is recruiting people who have types of female reproductive system cancers called rare epithelial ovarian, fallopian tube or primary peritoneal cancer. In order to take part, patients must have previously received treatment for their cancer.
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. In this clinical trial, depending on the biomarkers found in your cancer and if you meet all the criteria of an open and enrolling treatment arm, you will get either:
- ipataserib plus paclitaxel
- cobimetinib
- trastuzumab emtansine
- giredestrant plus abemaciclib
- inavolisib plus palbociclib
- inavolisib plus palbociclib plus letrozole
- atezolizumab plus bevacizumab
- inavolisib plus olaparib
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must be at least 18 years old and have been diagnosed with certain types of female reproductive system cancer: rare epithelial ovarian, fallopian tube or primary peritoneal cancer according to certain measures. You must have previously received treatment for your disease, including at least one platinum-based treatment.
You must not be pregnant or breastfeeding, or intending to become pregnant or to breastfeed, during the clinical trial. You may also not be able to take part in this clinical trial if you have previously received certain other medications or have certain other medical conditions. For each treatment available in this clinical trial, the clinical trial doctor may also discuss other reasons why you may not be able to take part.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
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 and your doctor can advise on how your tissue sample may be taken.
Once enrolled on the clinical trial, patients will be assigned to one of eight groups (treatment arms) depending on the biomarkers found and which treatment arms are open and enrolling participants. This will decide 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 each 28-day cycle, plus paclitaxel as an infusion into the vein on Days 1, 8 and 15 of each 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 diarrhoea
- 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 each 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 each 21-day cycle
- Patients who are ER-positive will receive giredestrant given as a pill once a day on Days 1–28 of each 28-day cycle, plus abemaciclib given as a pill twice a day on Days 1–28 of each 28-day cycle
- Patients with changes in the PIK3CA gene will receive inavolisib given as a pill once a day on Days 1–28 of each 28-day cycle, plus palbociclib given as a pill once a day on Days 1–21 of each 28-day cycle
- Patients who are ER-positive and with changes in the PIK3CA gene will receive inavolisib given as a pill once a day on Days 1–28 of each 28-day cycle, plus palbociclib given as a pill once a day on Days 1–21 of each 28-day cycle, plus letrozole given as a pill once a day on Days 1–28 of each 28-day cycle
Patients with more than one biomarker will be assigned to the treatment arm with the fewest expected patients that is open and enrolling.
Patients who are not matched to one of the treatment arms listed above will either receive:
- atezolizumab plus bevacizumab, each given as infusions into the vein on Day 1 of each 21-day cycle, OR
- inavolisib given as a pill once a day on Days 1–28 of each 28-day cycle, plus olaparib given as a pill twice a day on Days 1–28 of each 28-day cycle
This is an open-label clinical trial. This means that both you and your clinical trial doctor will know which treatment you are being given.
How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment that you have been assigned to, depending on the biomarkers found in your cancer, for as long as it can help you. You are free to stop this treatment at any time.
After finishing your treatment, you will still be contacted by the clinical trial doctor roughly every 3 months, as long as you agree to this. These check-ups may be in a clinic or over the phone and will include checks to see if you have had any side effects since your last dose and whether you have received any other treatments since.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04931342
Trial-identifier: NCT04931342
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT04931342 , WO42178 , GOG-3051, ENGOT-GYN2
Trial Identifier
Ipatasertib, Cobimetinib, Trastuzumab Emtansine, Atezolizumab, Bevacizumab, Paclitaxel, Giredestrant, Abemaciclib, Inavolisib, Palbociclib, Letrozole, Olaparib, Luteinizing Hormone-Releasing Hormone (LHRH) Agonists, Cyclophosphamide, Inavolisib
Treatments
Ovarian Cancer
Condition
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
Eligibility Criteria
Female
Gender
≥18 Years
Age
No
Healthy Volunteers
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
Exclusion Criteria
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
For the latest version of this information please go to www.forpatients.roche.com