Clinical trial · Interventional
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cobimetinib | Drug | Cobimetinib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Giredestrant | Drug | — | UNRESOLVED |
| Inavolisib | Drug | Inavolisib | ALIAS |
| Ipatasertib | Drug | Ipatasertib | ALIAS |
| Letrozole |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors)
- description
- Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
- interventionNames
- Drug: Ipatasertib
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors)
- description
- Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
- interventionNames
- Drug: Cobimetinib
- type
- EXPERIMENTAL
- label
- Trastuzumab Emtansine (ERBB2-amplified/mutant tumors)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRay-Coquard I, Ledermann J, DeFazio A, Okamoto A, Gershenson D. Controversies in the organization and structure of management for rare tumors. Int J Gynecol Cancer. 2025 Mar;35(3):101669. doi: 10.1016/j.ijgc.2025.101669. Epub 2025 Jan 29. PMID 40022843