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

Last updated: March 17, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

2

Condition

Ovarian Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

Luteinizing Hormone-Releasing Hormone (LHRH) Agonists

Giredestrant

Bevacizumab

Clinical Study ID

NCT04931342
WO42178
GOG-3051
ENGOT-GYN2
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Persistent or recurrent EOC that meets the following criteria: Histologicallyconfirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian,fallopian tube, or primary peritoneal cancer, including but not limited to low-gradeserous 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 cellcarcinoma of the ovary, hypercalcemic type (SCCOHT). Disease that is not amenable tocurative 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 wasplatinum-based. Hormonal therapy does not count as a line of therapy.

  • Platinum-resistant disease, defined as disease progression during or within 6 monthsof last platinum therapy, with the following exception: Participants with primaryplatinum-refractory disease are excluded.

  • Submission of a representative tumor specimen that is suitable for next-generationsequencing (NGS) testing and estrogen receptor immunohistochemistry (ER IHC) todetermine treatment arm assignment and for central pathology review.

  • Submission of the local pathology report and, if available, any associated stainedslides that supported the local diagnosis of the histology (to be used for centralpathology 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 usecontraception, and agreement to refrain from donating eggs (if applicable)

  • In addition to the general inclusion criteria above, participants must meet all ofthe arm-specific inclusion criteria for the respective arm

Exclusion

General Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant or breastfeed during thestudy

  • Primary platinum-refractory disease, defined as progression during or within 4 weeksafter 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 priordiagnosis of primary endometrial cancer is permitted if it meets all of thefollowing conditions: Stage IA, no lymphovascular invasion, International Federationof Gynecology and Obstetrics Grade 1 or 2, not a high-grade subtype.

  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage 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 toinitiation of study treatment

  • Treatment with hormonal therapy within 14 days prior to initiation of studytreatment

  • In addition to the general exclusion criteria above, participants can not meet anyof the arm-specific exclusion criteria for the respective arm

Study Design

Total Participants: 176
Treatment Group(s): 14
Primary Treatment: Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
Phase: 2
Study Start date:
October 07, 2021
Estimated Completion Date:
May 30, 2028

Connect with a study center

  • Cabrini Hospital

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Cabrini Hospital; Cabrini Foundation

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • St John of God Hospital; Bendat Cancer Centre

    Subiaco, Western Australia 6008
    Australia

    Site Not Available

  • UZ Leuven; Gyneacologische Oncologie

    Leuven, 3000
    Belgium

    Site Not Available

  • CHU Sart-Tilman

    Liège, 4000
    Belgium

    Site Not Available

  • Kingston General Hospital

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

  • McGill University Health Centre - Glen Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Fakultni nemocnice Brno Bohunice

    Brno, 625 00
    Czechia

    Site Not Available

  • Gynekologicko-porodnicka klinika

    Prague, 120 00
    Czechia

    Site Not Available

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon Cedex, 25030
    France

    Site Not Available

  • Institut Bergonie; Oncologie

    Bordeaux, 33076
    France

    Site Not Available

  • Centre Francois Baclesse

    Caen, 14076
    France

    Site Not Available

  • Centre Francois Baclesse; Oncologie

    Caen, 14076
    France

    Site Not Available

  • CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie

    Lyon, 69373
    France

    Site Not Available

  • Centre Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298
    France

    Site Not Available

  • Groupe Hospitalier Diaconesses

    Paris, 75020
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes, 35042
    France

    Site Not Available

  • ICO - Site René Gauducheau

    Saint Herblain, 44805
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Gustave Roussy

    Villejuif CEDEX, 94800
    France

    Site Not Available

  • Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie

    Berlin, 13353
    Germany

    Site Not Available

  • Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

    Dresden, 01307
    Germany

    Site Not Available

  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie

    Essen, 45136
    Germany

    Site Not Available

  • Universitätsklinikum Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Universitätsklinikum Mannheim; Frauenklinik

    Mannheim, 68167
    Germany

    Site Not Available

  • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

    Muenchen, 81377
    Germany

    Site Not Available

  • Istituto Tumori Napoli

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma, Lazio 00168
    Italy

    Site Not Available

  • IRCCS S. Raffaele

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • IRCCS S. Raffaele; Ginecologia Oncologica

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

    Milano, Lombardia 20141
    Italy

    Site Not Available

  • I.R.C.C. Candiolo; Oncologia Medica e Ematologia

    Candiolo, Piemonte 10060
    Italy

    Site Not Available

  • A.O. U. Consorziale Policlinico di Bari

    Bari, Puglia 70124
    Italy

    Site Not Available

  • A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, (0)6351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • LLC Medscan

    Moskva, Moskovskaja Oblast 119421
    Russian Federation

    Site Not Available

  • FSBI "Federal Medical Research Center n.a. V.A.Almazov"

    Sankt-peterburg, Sankt Petersburg 197341
    Russian Federation

    Site Not Available

  • Chelyabisnk regional clinical center for oncology and nuclear medicine

    Chelyabinsk, Sverdlovsk 454087
    Russian Federation

    Site Not Available

  • FSBI "Federal Medical Research Center n.a. V.A.Almazov"

    St. Petersburg, 197341
    Russian Federation

    Site Not Available

  • Institutio Catalan De Oncologia

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Institutio Catalan De Oncologia

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Malaga, 29010
    Spain

    Site Not Available

  • Hôpitaux Universitaires de Genève

    Genève, 1205
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève; Département d'oncologie

    Genève, 1205
    Switzerland

    Site Not Available

  • Adana Baskent University Medical Faculty; Oncology

    Adana, 01220
    Turkey

    Site Not Available

  • Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü

    Ankara, 06490
    Turkey

    Site Not Available

  • Koc University Medical Faculty; Department of Gynecology & Obstetrics

    Istanbul, 34010
    Turkey

    Site Not Available

  • Koc University Medical Faculty; Department of Gynecology & Obstetrics

    Topkapi, 34010
    Turkey

    Site Not Available

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Western General Hospital; Edinburgh Cancer Center

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • Arizona Oncology - HOPE Wilmot

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Kaiser Permanente - Irvine

    Irvine, California 92618
    United States

    Site Not Available

  • UCSF Helen Diller Family CCC

    San Francisco, California 94158
    United States

    Site Not Available

  • Northwestern University Medical School; Drug Information Center

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Minnesota Oncology Hematology

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center; Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Northwest Cancer Specialists, P.C.

    Tigard, Oregon 97223
    United States

    Site Not Available

  • Pinnacle Health; Harrisburg Hospital Pharmacy

    Harrisburg, Pennsylvania 17101
    United States

    Site Not Available

  • Magee-Woman's Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390-8813
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Site Not Available

  • University of Washington - Seattle Cancer Care Alliance; Medical Oncology

    Seattle, Washington 98109
    United States

    Site Not Available

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