Clinical trial NCT04931342: A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
First posted: 2021-06-18
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 outcomes:
measure: Confirmed Objective Response Rate (ORR)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to approximately 5 years
measure: Disease Contral Rate (DCR)
timeFrame: Up to approximately 5 years
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 5 years
measure: 6-Month PFS Rate
timeFrame: Up to 6 month
measure: Overall Survival (OS)
timeFrame: Up to approximately 5 years
measure: Confirmed ORR as Determined by IRC (Independent Review Committee)
timeFrame: Up to approximately 5 years
measure: DOR as Determined by IRC
timeFrame: Up to approximately 5 years
measure: DCR as Determined by IRC
timeFrame: Up to approximately 5 years
measure: PFS as Determined by IRC
timeFrame: Up to approximately 5 years
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family CCC
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: The Woodlands
country: United States
facility: Texas Oncology - Gulf Coast
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: University of Washington - Seattle Cancer Care Alliance
state: Washington
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Prague
country: Czechia
facility: Gynekologicko-porodnicka klinika
city: Besançon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Caen
country: France
facility: Centre Francois Baclesse
city: Lyon
country: France
facility: Centre Leon Berard
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif CEDEX
country: France
facility: Gustave Roussy
city: Essen
country: Germany
facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Napoli
country: Italy
facility: Istituto Tumori Napoli
state: Campania
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
city: Milano
country: Italy
facility: IRCCS S. Raffaele
state: Lombardia
city: Bari
country: Italy
facility: A.O. U. Consorziale Policlinico di Bari
state: Puglia
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Barcelona
country: Spain
facility: Institutio Catalan De Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Adana
country: Turkey
facility: Adana Baskent University Medical Faculty; Oncology
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü
city: Istanbul
country: Turkey
facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust - University College Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: