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

Ovarian Cancer Clinical Trial

— BOUQUET  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04931342
• Other study ID #: WO42178
• Secondary ID: GOG-3051ENGOT-GY
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 7, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 176
• Est. completion date: December 31, 2028
• Est. primary completion date: May 30, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Cabrini Hospital; Cabrini Foundation	Malvern	Victoria
Canada	McGill University Health Centre - Glen Site	Montreal	Quebec
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Czechia	Fakultni nemocnice Brno Bohunice	Brno
Czechia	Gynekologicko-porodnicka klinika	Prague
France	CHU Besançon - Hôpital Jean Minjoz	Besançon Cedex
France	Institut Bergonie; Oncologie	Bordeaux
France	Centre Francois Baclesse; Oncologie	Caen
France	CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie	Lyon
France	Institut Régional du Cancer de Montpellier	Montpellier
France	Groupe Hospitalier Diaconesses	Paris
France	Centre Eugène Marquis	Rennes
France	ICO - Site René Gauducheau	Saint Herblain
France	Institut Claudius Regaud; Departement Oncologie Medicale	Toulouse
France	Gustave Roussy	Villejuif
Germany	Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie	Berlin
Germany	Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe	Dresden
Germany	Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie	Essen
Germany	Universitätsklinikum Mannheim; Frauenklinik	Mannheim
Germany	Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde	Muenchen
Italy	A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica	Bari	Puglia
Italy	I.R.C.C. Candiolo; Oncologia Medica e Ematologia	Candiolo	Piemonte
Italy	Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica	Milano	Lombardia
Italy	IRCCS S. Raffaele; Ginecologia Oncologica	Milano	Lombardia
Italy	Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica	Napoli	Campania
Italy	Policlinico Universitario Agostino Gemelli	Roma	Lazio
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Russian Federation	Chelyabisnk regional clinical center for oncology and nuclear medicine	Chelyabinsk	Sverdlovsk
Russian Federation	LLC Medscan	Moskva	Moskovskaja Oblast
Russian Federation	FSBI "Federal Medical Research Center n.a. V.A.Almazov"	Sankt-peterburg	Sankt Petersburg
Spain	Institutio Catalan De Oncologia	Badalona	Barcelona
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga
Switzerland	Hôpitaux Universitaires de Genève; Département d'oncologie	Genève
Turkey	Adana Baskent University Medical Faculty; Oncology	Adana
Turkey	Baskent Universitesi Ankara Hastanesi; Tibbi Onkoloji Bölümü	Ankara
Turkey	Koc University Medical Faculty; Department of Gynecology & Obstetrics	Istanbul
United Kingdom	Western General Hospital; Edinburgh Cancer Center	Edinburgh
United Kingdom	University College London Hospitals NHS Foundation Trust - University College Hospital	London
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Ohio State University	Columbus	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	Kaiser Permanente - Irvine	Irvine	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	University of Oklahoma Health Sciences Center; Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology	Saint Louis	Missouri
United States	Minnesota Oncology Hematology	Saint Paul	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	UCSF Helen Diller Family CCC	San Francisco	California
United States	University of Washington - Seattle Cancer Care Alliance; Medical Oncology	Seattle	Washington
United States	Texas Oncology - Gulf Coast	The Woodlands	Texas
United States	Arizona Oncology - HOPE Wilmot	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Hoffmann-La Roche	European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  France,  Germany,  Italy,  Korea, Republic of,  Russian Federation,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Objective Response Rate (ORR)	Confirmed ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) (demonstrated on two consecutive occasions >=4 weeks apart), as determined by the investigator according to RECIST v1.1.	Up to approximately 5 years
Secondary	Duration of Response (DOR)	DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.	Up to approximately 5 years
Secondary	Disease Contral Rate (DCR)	DCR is defined as the proportion of participants with a confirmed CR or PR, or stable disease maintained for at least 16 weeks, as determined by the investigator according to RECIST v1.1.	Up to approximately 5 years
Secondary	Progression Free Survival (PFS)	PFS after start of treatment is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.	Up to approximately 5 years
Secondary	6-Month PFS Rate	6-month PFS rate is defined as the proportion of participants who remained alive and progression-free at 6 months after start of treatment, as determined by the investigator according to RECIST v1.1.	Up to 6 month
Secondary	Overall Survival (OS)	OS after start of treatment is defined as the time from start of treatment to death from any cause.	Up to approximately 5 years
Secondary	Confirmed ORR as Determined by IRC (Independent Review Committee)	Confirmed ORR, as determined by the IRC according to RECIST v1.1.	Up to approximately 5 years
Secondary	DOR as Determined by IRC	DOR, as determined by the IRC according to RECIST v1.1	Up to approximately 5 years
Secondary	DCR as Determined by IRC	DCR, as determined by the IRC according to RECIST v1.1	Up to approximately 5 years
Secondary	PFS as Determined by IRC	PFS, as determined by the IRC according to RECIST v1.1	Up to approximately 5 years
Secondary	Percentage of Participants With Adverse Events	Percentage of participants with adverse events.	Up to approximately 5 years