Ovarian Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

400

Study ID:

NCT04931342

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 61 Locations for this study

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Arizona Oncology - HOPE Wilmot
Tucson Arizona, 85710, United States
Kaiser Permanente - Irvine
Irvine California, 92618, United States
Minnesota Oncology Hematology
Saint Paul Minnesota, 55102, United States
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
Saint Louis Missouri, 63108, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Ohio State University
Columbus Ohio, 43210, United States
University of Oklahoma Health Sciences Center; Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Northwest Cancer Specialists, P.C.
Tigard Oregon, 97223, United States
Pinnacle Health; Harrisburg Hospital Pharmacy
Harrisburg Pennsylvania, 17101, United States
Magee-Woman's Hospital
Pittsburgh Pennsylvania, 15213, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Oncology - The Woodlands
The Woodlands Texas, 77380, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
University of Washington - Seattle Cancer Care Alliance; Medical Oncology
Seattle Washington, 98109, United States
Cabrini Hospital; Cabrini Foundation
Malvern Victoria, 3144, Australia
UZ Leuven; Gyneacologische Oncologie
Leuven , 3000, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Kingston General Hospital
Kingston Ontario, K7L 2, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
McGill University Health Centre - Glen Site
Montreal Quebec, H4A 3, Canada
Fakultni nemocnice Brno Bohunice
Brno , 625 0, Czechia
Gynekologicko-porodnicka klinika
Prague , 120 0, Czechia
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex , 25030, France
Institut Bergonie; Oncologie
Bordeaux , 33076, France
Centre Francois Baclesse; Oncologie
Caen , 14076, France
CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie
Lyon , 69373, France
Institut Régional du Cancer de Montpellier
Montpellier , 34298, France
Groupe Hospitalier Diaconesses
Paris , 75020, France
Centre Eugène Marquis
Rennes , 35042, France
ICO - Site René Gauducheau
Saint Herblain , 44805, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse , 31059, France
Gustave Roussy
Villejuif CEDEX , 94800, France
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
Dresden , 01307, Germany
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
Essen , 45136, Germany
Universitätsklinikum Mannheim; Frauenklinik
Mannheim , 68167, Germany
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
Muenchen , 81377, Germany
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
Napoli Campania, 80131, Italy
Policlinico Universitario Agostino Gemelli
Roma Lazio, 00168, Italy
IRCCS S. Raffaele; Ginecologia Oncologica
Milano Lombardia, 20132, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano Lombardia, 20141, Italy
I.R.C.C. Candiolo; Oncologia Medica e Ematologia
Candiolo Piemonte, 10060, Italy
A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica
Bari Puglia, 70124, Italy
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
LLC Medscan
Moskva Moskovskaja Oblast, 11942, Russian Federation
FSBI "Federal Medical Research Center n.a. V.A.Almazov"
Sankt-peterburg Sankt Petersburg, 19734, Russian Federation
Chelyabisnk regional clinical center for oncology and nuclear medicine
Chelyabinsk Sverdlovsk, 45408, Russian Federation
Institutio Catalan De Oncologia
Badalona Barcelona, 08916, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga , 29010, Spain
Hôpitaux Universitaires de Genève; Département d'oncologie
Genève , 1205, Switzerland
Adana Baskent University Medical Faculty; Oncology
Adana , 01220, Turkey
Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü
Ankara , 06490, Turkey
Koc University Medical Faculty; Department of Gynecology & Obstetrics
Istanbul , 34010, Turkey
Western General Hospital; Edinburgh Cancer Center
Edinburgh , EH4 2, United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London , NW1 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

400

Study ID:

NCT04931342

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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