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

Running, not enrolling · Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT04931342

Run by

Hoffmann-La Roche

People needed

176

Starts

2021-10-07

Expected to finish

2028-05-30

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• UCSF Helen Diller Family CCC — San Francisco, California, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Texas Oncology - Gulf Coast — The Woodlands, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• University of Washington - Seattle Cancer Care Alliance — Seattle, Washington, United States
• Cabrini Hospital — Malvern, Victoria, Australia
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• McGill University Health Centre - Glen Site — Montreal, Quebec, Canada
• Gynekologicko-porodnicka klinika — Prague, Czechia
• CHU Besançon - Hôpital Jean Minjoz — Besançon, France
• Centre Francois Baclesse — Caen, France
• Centre Leon Berard — Lyon, France
• Groupe Hospitalier Diaconesses — Paris, France
• Centre Eugène Marquis — Rennes, France
• ICO - Site René Gauducheau — Saint-Herblain, France
• Institut Claudius Regaud — Toulouse, France
• Gustave Roussy — Villejuif, France
• Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie — Essen, Germany
• Universitätsklinikum Mannheim — Mannheim, Germany
• A.O. U. Consorziale Policlinico di Bari — Bari, Apulia, Italy
• Istituto Tumori Napoli — Naples, Campania, Italy
• Policlinico Universitario Agostino Gemelli — Rome, Lazio, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.