Clinical trial • Phase II • Oncology

BEVACIZUMAB for Advanced cancer

Phase II trial of BEVACIZUMAB for Advanced cancer. open-label. 6000 participants.

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Advanced cancer
Trial Stage: Phase II
Drug Modality: Small molecule|Monoclonal antibody
Orphan Drug: Yes

Key dates

Initial CTIS Submission Date: 03-07-2024
First CTIS Authorization Date: 23-08-2024

Trial design

open-label Phase II trial across 23 sites in Norway.

Open Label: Yes
Biomarker Stratified: True: genomic or protein expression variant (molecular tumour profile)
Target Sample Size: 6000

Eligibility

Recruits 6000 Vulnerable population selected. Subject information and informed consent forms are provided (multiple L1_SIS and ICF documents are listed in the application documents). The public record does not provide an explicit description of assent procedures or proxy consent for minors/incapacitated participants..

Vulnerable Population: Vulnerable population selected. Subject information and informed consent forms are provided (multiple L1_SIS and ICF documents are listed in the application documents). The public record does not provide an explicit description of assent procedures or proxy consent for minors/incapacitated participants.

Inclusion criteria

{"criterion_text":"- ECOG performance status 0-2\n- Life expectancy minimum 3 months\n- Patient with a pathology-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.\n- Patients must have acceptable organ function as defined below (exceptions for haematological diagnoses): a)\tAbsolute neutrophil count ≥ 1.5 x109 / L b)\tHemoglobin > 9 g/dl c)\tPlatelets > 75,000/µl d)\tTotal bilirubin < 1.5 x institutional upper limit of normal (ULN) e)\tAST (SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases) f)\tCalculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2\n- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.\n- Results must be available from a genomic / molecular test performed in a preapproved laboratory (Section 10.1). The test used to qualify a patient for participation in IMPRESS-Norway may have been performed on any specimen of the patient’s tumour obtained at any point during the patient’s care at the discretion of the patient’s treating physician. Genomic assays performed on cell-free DNA in plasma (“liquid biopsies”) will also be acceptable if the genomic analysis is performed as defined in Section 10.5. NGS analyses will be performed on a newly sampled biopsy if possible. Information from these analyses might be used upon progression, for evaluation of possible new cohort-inclusion.\n- Have a genomic profile for which treatment with one of the approved targeted anti-cancer therapies included in this study has potential clinical benefit"}

Exclusion criteria

{"criterion_text":"- Patients eligible to enter other ongoing trials which have the potential to benefit the patients equally or more than a IMPRESS-Norway cohort, and for"}
{"criterion_text":"- Ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to anti-tumour treatment that was completed within 4 weeks prior to treatment initiation. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3.Patients with known allergy/hypersensitivity to the study drug (active substance or to any of the excipients)."}
{"criterion_text":"- Patients with acute gastrointestinal bleeding within 1 month of start of treatment"}
{"criterion_text":"- Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment"}

Endpoints

Primary endpoints

{"endpoint_text":"- Percentage of patients that are included and treated based on their molecular tumour profile;","definition_or_measurement_approach":""}
{"endpoint_text":"- Percentage of patients that are included and treated based on their molecular tumour profile;","definition_or_measurement_approach":""}
{"endpoint_text":"- Treatment-related grade ≥3 and serious adverse events","definition_or_measurement_approach":""}

Secondary endpoints

{"endpoint_text":"- Progression-free and overall survival","definition_or_measurement_approach":""}
{"endpoint_text":"- Duration of time on drug","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size: 6000
Recruitment Window Months: 141
Consent Approach: Informed consent is obtained using subject information sheets and informed consent forms (multiple L1_SIS and ICF documents are provided for each sub-protocol and a master screening ICF). The record lists the available ICF documents but does not specify languages or assent/proxy consent processes in the public record.

Geography

Total Number Of Sites: 23
Total Number Of Participants: 6000

Norway

Earliest CTIS Part Ii Submission Date: 09-08-2024
Latest Decision Or Authorization Date: 22-01-2026
Processing Time Days: 531
Number Of Sites: 23
Number Of Participants: 6000

Sites

Site Name: Helse Moere Og Romsdal HF
Department Name: Oncology
Contact Person Name: Hege Elvebakken
Contact Person Email: postmottak@helse-mr.no

Site Name: Helse Stavanger HF
Department Name: Oncology
Contact Person Name: Bjørnar Gilje
Contact Person Email: post@sus.no

Site Name: Vestre Viken HF
Department Name: Oncology, Baerum
Contact Person Name: Anastasia Nikitenko
Contact Person Email: postmottak@vestreviken.no

Site Name: Oslo University Hospital HF
Department Name: Oslo Myeloma Center
Contact Person Name: Fredrik Schjesvold
Contact Person Email: post@oslo-universitetssykehus.no

Site Name: Vestre Viken HF
Department Name: Oncology, Ringerike
Contact Person Name: Liv Hege Aksnes
Contact Person Email: postmottak@vestreviken.no

Site Name: Sykehuset Innlandet HF
Department Name: Oncology
Contact Person Name: Hedda Elisabeth von der Lippe Gythfeldt
Contact Person Email: postmottak@sykehuset-innlandet.no

Site Name: Helse Forde HF
Department Name: Oncology
Contact Person Name: Jaroslav Bublevic
Contact Person Email: post@helse-forde.no

Site Name: Sykehuset Telemark HF
Department Name: Oncology
Contact Person Name: Dalia Dietzel
Contact Person Email: postmottak@sthf.no

Site Name: Nordlandssykehuset HF
Department Name: Oncology
Contact Person Name: Astrid Dalhaug
Contact Person Email: postmottak@nordlandssykehuset.no

Site Name: Vestre Viken HF
Department Name: Oncology, Drammen
Contact Person Name: Odd Terje Brustugun
Contact Person Email: postmottak@vestreviken.no

Site Name: Akershus University Hospital
Department Name: Oncology
Contact Person Name: Anne Ree
Contact Person Email: postmottak@ahus.no

Site Name: Helse Fonna HF
Department Name: Oncology
Contact Person Name: Atle Totland
Contact Person Email: post@helse-fonna.no

Site Name: Sorlandet Sykehus HF
Department Name: Oncology
Contact Person Name: Marta Grønlie Cameron
Contact Person Email: postmottak@sshf.no

Site Name: Oslo University Hospital HF
Department Name: Taarnbygget, Kirkeveien 166
Contact Person Name: Andrea Lenartova
Contact Person Email: post@oslo-universitetssykehus.no

Site Name: Universitetssykehuset Nord-Norge HF
Department Name: Oncology
Contact Person Name: Egil Blix
Contact Person Email: post@unn.no

Site Name: Oslo University Hospital HF
Department Name: Hematology
Contact Person Name: Geir Olav Hjortland
Contact Person Email: post@oslo-universitetssykehus.no

Site Name: Nord-Trondelag Hospital Trust
Department Name: Oncology
Contact Person Name: Olav Toai Duc Nguyen
Contact Person Email: postmottak@hnt.no

Site Name: Vestfold Hospital Trust
Department Name: Oncology
Contact Person Name: Andre Korneliussen
Contact Person Email: post@siv.no

Site Name: Ostfold Hospital Trust
Department Name: Oncology
Contact Person Name: Øyvind Tennøe
Contact Person Email: postmottak@so-hf.no

Site Name: Helse Bergen HF
Department Name: Oncology
Contact Person Name: Line Bjørge
Contact Person Email: postmottak@helse-bergen.no

Site Name: Lovisenberg Diakonale Sykehus AS
Department Name: Oncology
Contact Person Name: Jan Øyvind Kvaløy
Contact Person Email: post@lds.no

Site Name: St. Olavs Hospital HF
Department Name: Oncology
Contact Person Name: Åsmund Flobak
Contact Person Email: post@stolav.no

Sponsor

Primary sponsor

Full Name: Oslo University Hospital HF
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Norway

Third parties

{"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"sponsorDuties code: 14","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 USE
Route: INTRAVENOUS USE
Authorisation Status: Marketing authorisation number: EU/1/04/300/001
Maximum Dose: 7.5 mg/kg

Investigational Product Name: BORTEZOMIB
Active Substance: BORTEZOMIB
Modality: Small molecule
Routes Of Administration: SUBCUTANEOUS USE
Route: SUBCUTANEOUS USE
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 1.3 mg/m2

Investigational Product Name: Zelboraf 240 mg film-coated tablets
Active Substance: VEMURAFENIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/12/751/001
Maximum Dose: 1920 mg

Investigational Product Name: Retsevmo 40 mg hard capsules
Active Substance: SELPERCATINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/20/1527/006
Orphan Designation: Yes
Maximum Dose: 320 mg

Investigational Product Name: Rozlytrek 100 mg hard capsules
Active Substance: ENTRECTINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/20/1460/001
Orphan Designation: Yes
Maximum Dose: 600 mg

Investigational Product Name: Tabrecta 200 mg film-coated tablets
Active Substance: CAPMATINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/22/1650/004
Maximum Dose: 800 mg

Investigational Product Name: Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance: ATEZOLIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS USE
Route: INTRAVENOUS USE
Authorisation Status: Marketing authorisation number: EU/1/17/1220/001
Orphan Designation: Yes
Maximum Dose: 1680 mg

Investigational Product Name: Alecensa 150 mg hard capsules
Active Substance: ALECTINIB HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/16/1169/001
Orphan Designation: Yes
Maximum Dose: 1200 mg

Investigational Product Name: Pemazyre 4.5 mg tablets
Active Substance: PEMIGATINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/21/1535/001
Orphan Designation: Yes
Maximum Dose: 13.5 mg

Investigational Product Name: Phesgo 600 mg/600 mg solution for injection
Active Substance: TRASTUZUMAB, PERTUZUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS USE
Route: SUBCUTANEOUS USE
Authorisation Status: Marketing authorisation number: EU/1/20/1497/002
Maximum Dose: 1200 mg

Investigational Product Name: HYDROXYCARBAMIDE
Active Substance: HYDROXYCARBAMIDE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 500 mg

Investigational Product Name: Piqray 200 mg film-coated tablets
Active Substance: ALPELISIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/20/1455/008
Maximum Dose: 300 mg

Investigational Product Name: Mekinist 0.5 mg film-coated tablets
Active Substance: TRAMETINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/14/931/002
Maximum Dose: 2 mg

Investigational Product Name: Tecentriq 840 mg concentrate for solution for infusion
Active Substance: ATEZOLIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS USE
Route: INTRAVENOUS USE
Authorisation Status: Marketing authorisation number: EU/1/17/1220/002
Maximum Dose: 1680 mg

Investigational Product Name: Tafinlar 75 mg hard capsules
Active Substance: DABRAFENIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/13/865/004
Maximum Dose: 300 mg

Investigational Product Name: IMATINIB
Active Substance: IMATINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 400 mg

Investigational Product Name: AMIVANTAMAB
Active Substance: AMIVANTAMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS INJECTION
Route: SUBCUTANEOUS INJECTION
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 2240 mg

Investigational Product Name: CERITINIB
Active Substance: CERITINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 450 mg

Investigational Product Name: IMATINIB
Active Substance: IMATINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 400 mg

Investigational Product Name: Tecentriq 1 875 mg solution for injection
Active Substance: ATEZOLIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS USE
Route: SUBCUTANEOUS USE
Authorisation Status: Marketing authorisation number: EU/1/17/1220/003
Maximum Dose: 1875 mg

Investigational Product Name: Retsevmo 80 mg hard capsules
Active Substance: SELPERCATINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/20/1527/011
Maximum Dose: 320 mg

Investigational Product Name: Mekinist 2 mg film-coated tablets
Active Substance: TRAMETINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/14/931/006
Maximum Dose: 2 mg

Investigational Product Name: Erivedge 150 mg hard capsules
Active Substance: VISMODEGIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/13/848/001
Maximum Dose: 150 mg

Investigational Product Name: Fulvestrant SUN 250 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Active Substance: FULVESTRANT
Modality: Small molecule
Routes Of Administration: INTRAMUSCULAR
Route: INTRAMUSCULAR
Authorisation Status: Marketing authorisation number: 19-13037
Orphan Designation: Yes
Maximum Dose: 500 mg

Investigational Product Name: Piqray 150 mg film-coated tablets
Active Substance: ALPELISIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/20/1455/002
Maximum Dose: 300 mg

Investigational Product Name: Rozlytrek 200 mg hard capsules
Active Substance: ENTRECTINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/20/1460/002
Maximum Dose: 600 mg

Investigational Product Name: Tabrecta 150 mg film-coated tablets
Active Substance: CAPMATINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/22/1650/002
Maximum Dose: 800 mg

Investigational Product Name: NIRAPARIB
Active Substance: NIRAPARIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 300 mg

Investigational Product Name: Cotellic 20 mg film-coated tablets
Active Substance: COBIMETINIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/15/1048/001
Maximum Dose: 600 mg

Investigational Product Name: MELPHALAN
Active Substance: MELPHALAN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 2 mg

Investigational Product Name: DOSTARLIMAB
Active Substance: DOSTARLIMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS USE
Route: INTRAVENOUS USE
Authorisation Status: No marketing authorisation number listed
Orphan Designation: Yes
Maximum Dose: 500 mg

Investigational Product Name: AMIVANTAMAB
Active Substance: AMIVANTAMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS ADMINISTRATION
Route: INTRAVENOUS ADMINISTRATION
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 1400 mg

Investigational Product Name: TEPMETKO 225 mg film-coated tablets
Active Substance: TEPOTINIB
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketing authorisation number: EU/1/21/1596/001
Maximum Dose: 450 mg

Investigational Product Name: Phesgo 1200 mg/600 mg solution for injection
Active Substance: TRASTUZUMAB, PERTUZUMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS USE
Route: SUBCUTANEOUS USE
Authorisation Status: Marketing authorisation number: EU/1/20/1497/001
Maximum Dose: 1200 mg

Investigational Product Name: DACTINOMYCIN
Active Substance: DACTINOMYCIN
Modality: Small molecule
Routes Of Administration: INTRAVENEOUS
Route: INTRAVENEOUS
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 15 µg/Kg

Investigational Product Name: Piqray 50 mg and 200 mg film-coated tablets
Active Substance: ALPELISIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/20/1455/005
Maximum Dose: 300 mg

Investigational Product Name: DEXAMETHASONE
Active Substance: DEXAMETHASONE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: No marketing authorisation number listed
Maximum Dose: 20 mg

Investigational Product Name: Tafinlar 50 mg hard capsules
Active Substance: DABRAFENIB
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/13/865/002
Maximum Dose: 300 mg

Investigational Product Name: Avastin 25 mg/ml concentrate for solution for infusion.
Active Substance: BEVACIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS USE
Route: INTRAVENOUS USE
Authorisation Status: Marketing authorisation number: EU/1/04/300/002
Maximum Dose: 7.5 mg/kg

Investigational Product Name: Lynparza 100 mg film-coated tablets
Active Substance: OLAPARIB
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketing authorisation number: EU/1/14/959/002
Maximum Dose: 600 mg

Investigational Product Name: Lynparza 150 mg film-coated tablets
Active Substance: OLAPARIB
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketing authorisation number: EU/1/14/959/004
Maximum Dose: 600 mg

Combination Treatment: Yes

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