NCT04931342Active, not recruitingPhase 2
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 · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 176 (actual)
- First submitted
- 9 Jun 2021
- Start date
- 7 Oct 2021
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Ovarian cancer
- NCT number
- NCT04931342
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 176
- From 7 Oct 2021 to the primary completion date, 28 Feb 2028
- 41 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cabrini Hospital Coordinator of this site? Confirm its status | Malvern | Australia | Unknown status |
| McGill University Health Centre Glen Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Hôpitaux universitaires de Genève Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Gynekologicko-porodnicka klinika Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitätsklinikum Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Institutio Catalan De Oncologia Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clinico Universitario Virgen de La Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| CHU Besancon - Hopital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Groupe Hospitalier Diaconesses Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| ICO - Site René Gauducheau Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| University College London Hospitals NHS Foundation Trust - University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| A.O. U. Consorziale Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| IRCCS S. Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto Tumori Napoli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| LLC Medscan Coordinator of this site? Confirm its status | Moskva | Russia | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| UCSF Helen Diller Family CCC Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of Washington - Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Texas Oncology- Gulf Coast Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Adana Baskent University Medical Faculty; Oncology Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Koc University Medical Faculty; Department of Gynecology & Obstetrics Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.