Clinical trial • Phase II • Oncology
BEVACIZUMAB for Persistent or recurrent epithelial ovarian cancer | Ovarian epithelial cancer
Phase II trial of BEVACIZUMAB for Persistent or recurrent epithelial ovarian cancer | Ovarian epithelial cancer. open-label. 51 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Persistent or recurrent epithelial ovarian cancer | Ovarian epithelial cancer
- Trial Stage
- Phase II
- Drug Modality
- Small molecule|Monoclonal antibody|ADC
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 19-12-2023
- First CTIS Authorization Date
- 08-02-2024
Trial design
open-label Phase II trial in Italy, Czechia, Germany and others.
- Open Label
- Yes
- Biomarker Stratified
- True, NGS and ER IHC
- Target Sample Size
- 51
Eligibility
Recruits 51 Vulnerable population not selected; participants are adult females. Informed consent is obtained from participants (no assent procedures described)..
- Vulnerable Population
- Vulnerable population not selected; participants are adult females. Informed consent is obtained from participants (no assent procedures described).
Inclusion criteria
- {"criterion_text":"- Persistent or recurrent epithelial ovarian cancer (EOC) that meets the following criteria: a) 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 cancer, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma, and small cell carcinoma of the ovary, hypercalcemic type). A primary gastrointestinal carcinoma must have been excluded. b) Disease that is not amenable to curative surgery"}
- {"criterion_text":"- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Platinum-resistant disease (defined as disease progression during or within 6 months of last platinum therapy) with the following exception: patients with primary platinum-refractory disease are excluded."}
- {"criterion_text":"- At the time of prescreening, submission of a representative tumor specimen that is suitable for NGS testing and ER IHC to determine treatment arm assignment and for central pathology review."}
Exclusion criteria
- {"criterion_text":"- Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer"}
- {"criterion_text":"- Current diagnosis of solely borderline epithelial ovarian tumor (formerly considered tumors of low malignant potential)"}
- {"criterion_text":"- Current diagnosis of non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord-stromal tumors)"}
- {"criterion_text":"- Current diagnosis of synchronous primary endometrial cancer"}
- {"criterion_text":"- Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment"}
- {"criterion_text":"- History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Confirmed ORR as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Objective response rate confirmed by investigator using RECIST v1.1"}
Secondary endpoints
- {"endpoint_text":"- 1. DOR as determined by the investigator and IRC according to RECIST v1.1","definition_or_measurement_approach":"Duration of response determined by investigator and Independent Review Committee (IRC) according to RECIST v1.1"}
- {"endpoint_text":"- 2. DCR as determined by the investigator and IRC according to RECIST v1.1","definition_or_measurement_approach":"Disease control rate determined by investigator and IRC according to RECIST v1.1"}
- {"endpoint_text":"- 3. PFS as determined by the investigator and IRC according to RECIST v1.1","definition_or_measurement_approach":"Progression-free survival determined by investigator and IRC according to RECIST v1.1"}
- {"endpoint_text":"- 4. Overall survival","definition_or_measurement_approach":"Overall survival (time from randomisation/enrolment to death from any cause)"}
- {"endpoint_text":"- 5. Confirmed ORR, as determined by the IRC according to RECIST v1.1","definition_or_measurement_approach":"Confirmed objective response rate as adjudicated by the Independent Review Committee using RECIST v1.1"}
- {"endpoint_text":"- 6. Six (6)-month PFS rate as determined by the investigator","definition_or_measurement_approach":"Proportion of participants alive and progression-free at 6 months as determined by investigator"}
- {"endpoint_text":"- 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0; incidence and severity recorded"}
Recruitment
- Planned Sample Size
- 51
- Recruitment Window Months
- 82
- Consent Approach
- Informed consent obtained from participants (adult female subjects). Multiple language subject information and consent forms available (examples in English, German, French, Spanish, Italian, Czech). No assent procedures described.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 57
Italy
- Earliest CTIS Part Ii Submission Date
- 12-01-2024
- Latest Decision Or Authorization Date
- 21-02-2025
- Processing Time Days
- 406
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Unità Operativa Oncologia Medica Uro-Ginecologica
- Principal Investigator Name
- Sandro Pignata
- Principal Investigator Email
- s.pignata@istitutotumori.na.it
- Contact Person Name
- Sandro Pignata
- Contact Person Email
- s.pignata@istitutotumori.na.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Ginecologia oncologica
- Principal Investigator Name
- Giorgia Mangili
- Principal Investigator Email
- mangili.giorgia@hsr.it
- Contact Person Name
- Giorgia Mangili
- Contact Person Email
- mangili.giorgia@hsr.it
Czechia
- Earliest CTIS Part Ii Submission Date
- 12-01-2024
- Latest Decision Or Authorization Date
- 21-02-2025
- Processing Time Days
- 406
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Gynekologicko-porodnicka klinika
- Principal Investigator Name
- David Cibula
- Principal Investigator Email
- dc@davidcibula.cz
- Contact Person Name
- David Cibula
- Contact Person Email
- dc@davidcibula.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Gynekologicko-porodnicka klinika
- Principal Investigator Name
- Vit Weinberger
- Principal Investigator Email
- weinberger.vit@fnbrno.cz
- Contact Person Name
- Vit Weinberger
- Contact Person Email
- weinberger.vit@fnbrno.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 12-01-2024
- Latest Decision Or Authorization Date
- 06-01-2026
- Processing Time Days
- 725
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Konservative Gynäkologische Onkologie
- Principal Investigator Name
- Frederik Marmé
- Principal Investigator Email
- frederik.marme@umm.de
- Contact Person Name
- Frederik Marmé
- Contact Person Email
- frederik.marme@umm.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Klinik für Gynäkologie & Gynäkologische Onkologie
- Principal Investigator Name
- Philipp Harter
- Principal Investigator Email
- P.Harter@kem-med.com
- Contact Person Name
- Philipp Harter
- Contact Person Email
- P.Harter@kem-med.com
France
- Earliest CTIS Part Ii Submission Date
- 12-01-2024
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 710
- Number Of Sites
- 8
- Number Of Participants
- 32
Sites
- Site Name
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Department Name
- oncologie
- Principal Investigator Name
- Frederic Selle
- Principal Investigator Email
- fselle@hopital-dcss.org
- Contact Person Name
- Frederic Selle
- Contact Person Email
- fselle@hopital-dcss.org
- Site Name
- Besancon University Hospital Center
- Department Name
- oncologie
- Principal Investigator Name
- Laura Mansi
- Principal Investigator Email
- lmansi@chu-besancon.fr
- Contact Person Name
- Laura Mansi
- Contact Person Email
- lmansi@chu-besancon.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- oncologie
- Principal Investigator Name
- Patricia Pautier
- Principal Investigator Email
- patricia.pautier@gustaveroussy.fr
- Contact Person Name
- Patricia Pautier
- Contact Person Email
- patricia.pautier@gustaveroussy.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- oncologie
- Principal Investigator Name
- Florence Joly
- Principal Investigator Email
- f.joly@baclesse.unicancer.fr
- Contact Person Name
- Florence Joly
- Contact Person Email
- f.joly@baclesse.unicancer.fr
- Site Name
- Centre Hospitalier Saint Joseph Saint Luc
- Department Name
- oncologie
- Principal Investigator Name
- Isabelle Ray Coquard
- Principal Investigator Email
- isabelle.ray-coquard@lyon.unicancer.fr
- Contact Person Name
- Isabelle Ray Coquard
- Contact Person Email
- isabelle.ray-coquard@lyon.unicancer.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- oncologie
- Principal Investigator Name
- Thibault De la Motte Rouge
- Principal Investigator Email
- t.delamotterouge@rennes.unicancer.fr
- Contact Person Name
- Thibault De la Motte Rouge
- Contact Person Email
- t.delamotterouge@rennes.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- oncologie
- Principal Investigator Name
- Dominique Berton-Rigaud
- Principal Investigator Email
- dominique.berton@ico.unicancer.fr
- Contact Person Name
- Dominique Berton-Rigaud
- Contact Person Email
- dominique.berton@ico.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- oncologie
- Principal Investigator Name
- Laurence GLADIEFF
- Principal Investigator Email
- gladieff.laurence@iuct-oncopole.fr
- Contact Person Name
- Laurence GLADIEFF
- Contact Person Email
- gladieff.laurence@iuct-oncopole.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 12-01-2024
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 710
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology
- Principal Investigator Name
- Andres Redondo Sanchez
- Principal Investigator Email
- aredondo12@gmail.com
- Contact Person Name
- Andres Redondo Sanchez
- Contact Person Email
- aredondo12@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Beatriz Pardo Burdalo
- Principal Investigator Email
- bpardo@iconcologia.net
- Contact Person Name
- Beatriz Pardo Burdalo
- Contact Person Email
- bpardo@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Luis Manuel Manso Sanchez
- Principal Investigator Email
- luismanasosanchez@gmail.com
- Contact Person Name
- Luis Manuel Manso Sanchez
- Contact Person Email
- luismanasosanchez@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Maria Jose Bermejo Perez
- Principal Investigator Email
- cheberpe@gmail.com
- Contact Person Name
- Maria Jose Bermejo Perez
- Contact Person Email
- cheberpe@gmail.com
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Almac Clinical Technologies LLC
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging
- Name
- Labcorp Central Laboratory Services S.a.r.l.
Third parties
- {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Investigator Meetings","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Pathology Report Translations","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Avastin 25 mg/ml concentrate for solution for infusion.
- Active Substance
- BEVACIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 15 mg/Kg
- Investigational Product Name
- Lynparza 150 mg film-coated tablets
- Active Substance
- OLAPARIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Maximum Dose
- 600 mg
- Investigational Product Name
- Cotellic 20 mg film-coated tablets
- Active Substance
- COBIMETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 60 mg
- Investigational Product Name
- Ipatasertib
- Active Substance
- IPATASERTIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Not authorised
- Maximum Dose
- 400 mg
- Investigational Product Name
- INAVOLISIB
- Active Substance
- INAVOLISIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Not authorised
- Maximum Dose
- 9 mg
- Investigational Product Name
- Sindaxel 6 mg/ml concentrat pentru soluţie perfuzabilă
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 80 mg/m2
- Investigational Product Name
- Verzenios 50 mg film-coated tablets
- Active Substance
- ABEMACICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 300 mg
- Investigational Product Name
- Kadcyla 160 mg powder for concentrate for solution for infusion.
- Active Substance
- TRASTUZUMAB EMTANSINE
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 3.6 mg/Kg
- Investigational Product Name
- LETRO-cell® 2,5 mg Filmtabletten
- Active Substance
- LETROZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 2.5 mg
- Investigational Product Name
- RO7197597
- Active Substance
- GIREDESTRANT
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Not authorised
- Maximum Dose
- 30 mg
- Investigational Product Name
- Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 80 mg/m2
- Investigational Product Name
- Endoxan 50 mg dengtos tabletės
- Active Substance
- CYCLOPHOSPHAMIDE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 50 mg
- Investigational Product Name
- Tecentriq 1,200 mg concentrate for solution for infusion
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 1200 mg
- Investigational Product Name
- IBRANCE 125 mg film-coated tablets
- Active Substance
- PALBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 125 mg
- Combination Treatment
- Yes
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