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

• Status: Recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate the efficacy and safety of multiple biomarker-driven 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT); GOG Foundation
• Treatments: Ado-Trastuzumab Emtansine; Atezolizumab; Bevacizumab; Maytansine; Paclitaxel; Trastuzumab

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 (i.e., low-grade serous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, seromucinous carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, or small cell carcinoma of the ovary-hypercalcemic type); 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

• Platinum-resistant disease (disease progression within 6 months of last platinum therapy)

• Submission of a representative tumor specimen that is suitable for central molecular analysis (for mandatory NGS testing to determine treatment arm assignment)

• Submission of stained pathology slides, along with the associated pathology report (for central pathology review)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Adequate hematologic and end-organ function

• Female of childbearing potential must be willing to comply with adequate contraception

• 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 must meet all of the arm-specific exclusion criteria for the respective arm