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Clinical Trials in the UK / NCT04931342
Active, not recruiting Phase 2

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

NCT04931342 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2021-10-07
Last updated
2026-09-10

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

IpatasertibCobimetinibTrastuzumab EmtansineAtezolizumabBevacizumabPaclitaxelGiredestrantAbemaciclibInavolisibPalbociclibLetrozoleOlaparibLuteinizing Hormone-Releasing Hormone (LHRH) AgonistsCyclophosphamideInavolisib

Ipatasertib: Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)

Cobimetinib: Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)

Trastuzumab Emtansine: Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

Atezolizumab: Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

Bevacizumab: Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

Paclitaxel: Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)

Giredestrant: Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)

Abemaciclib: Abemaciclib will be administered by mouth twice a day during each 28-day cycle

Inavolisib: Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle

Palbociclib: Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle

Letrozole: Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle

Olaparib: Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle

Luteinizing Hormone-Releasing Hormone (LHRH) Agonists: LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.

Cyclophosphamide: Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)

Inavolisib: Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle

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

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
UCSF Helen Diller Family CCC San Francisco California
Washington University School of Medicine St Louis Missouri
Levine Cancer Institute Charlotte North Carolina
Ohio State University Columbus Ohio
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
Texas Oncology - Gulf Coast The Woodlands Texas
Virginia Oncology Associates Norfolk Virginia
University of Washington - Seattle Cancer Care Alliance Seattle Washington
Cabrini Hospital Malvern Victoria
Princess Margaret Cancer Center Toronto Ontario
McGill University Health Centre - Glen Site Montreal Quebec
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
Istituto Tumori Napoli Naples Campania
Policlinico Universitario Agostino Gemelli Rome Lazio
IRCCS S. Raffaele Milan Lombardy
LLC Medscan Moskva Moscow Oblast
Samsung Medical Center Seoul South Korea
Seoul National University Hospital Seoul South Korea
Severance Hospital, Yonsei University Health System Seoul South Korea
Asan Medical Center Seoul South Korea
Institutio Catalan De Oncologia Barcelona Spain
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Universitario La Paz Madrid Spain
Hospital Clinico Universitario Virgen de la Victoria Málaga Spain
Hôpitaux Universitaires de Genève Geneva Switzerland
Adana Baskent University Medical Faculty; Oncology Adana Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü Ankara Turkey (Türkiye)
Koc University Medical Faculty; Department of Gynecology & Obstetrics Istanbul Turkey (Türkiye)
Western General Hospital Edinburgh United Kingdom

+ 1 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Avastin (bevacizumab) drug profile → 📄 Verzenio (abemaciclib) drug profile → 📄 Ibrance (palbociclib) drug profile → 📄 Lynparza (olaparib) drug profile →

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04931342 on ClinicalTrials.gov ↗ ← All trials in the UK