A study aimed at examining the effects of different treatments on rare epithelial cancer types of the ovary, fallopian tubes, or primary peritoneum that have been previously treated and have different genetic modifications.

Australia, Belgium, Canada, Czechia, France, Germany, Italy, Korea, Republic of, Russian Federation, Spain, Switzerland, Turkey, United Kingdom, United States (ICTRP)

ICTRP Trial ID
NCT04931342 (ICTRP)

Official title (approved by ethics committee)
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 (BASEC)

Academic 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 (ICTRP)

Public title
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (ICTRP)

Disease under investigation
Ovarian Cancer (ICTRP)

Intervention under investigation
Drug: IpatasertibDrug: CobimetinibDrug: Trastuzumab EmtansineDrug: AtezolizumabDrug: BevacizumabDrug: PaclitaxelDrug: GiredestrantDrug: AbemaciclibDrug: InavolisibDrug: PalbociclibDrug: LetrozoleDrug: OlaparibDrug: Luteinizing Hormone-Releasing Hormone (LHRH) AgonistsDrug: CyclophosphamideDrug: Inavolisib (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion criteria
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 (ICTRP)

not available

Primary and secondary end points
Confirmed Objective Response Rate (ORR) (ICTRP)

Duration of Response (DOR);Disease Contral Rate (DCR);Progression Free Survival (PFS);6-Month PFS Rate;Overall Survival (OS);Confirmed ORR as Determined by IRC (Independent Review Committee);DOR as Determined by IRC;DCR as Determined by IRC;PFS as Determined by IRC;Percentage of Participants With Adverse Events (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
GOG Foundation;European Network of Gynaecological Oncological Trial Groups (ENGOT) (ICTRP)

Additional contacts
Clinical Trials, Hoffmann-La Roche (ICTRP)

Secondary trial IDs
GOG-3051, ENGOT-GYN2, WO42178 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04931342 (ICTRP)