About this trial
IMPRESS-Norway is a prospective, non-randomized clinical trial evaluating efficacy of commercially available, anti-cancer drugs prescribed for patients with advanced cancer diagnosed with potentially actionable alterations as revealed by molecular diagnostics. IMPRESS-Norway is a nation-wide study and all hospitals with an oncology and / or hematology department will be invited to participate in the study. The study will use a combined umbrella and basket design and a Simon two-stage model of expanding cohorts to follow up potentially effective combinations of biomarker and drug on specific indications. Sampling of biological material will be performed at presentation, during treatment and upon progression. Additional biomarker and translational analyses including whole genome sequencing (WGS) on tumour material and liquid biopsies, identifying mechanisms underlying drug sensitivity versus resistance will be performed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type of Participant and Health status
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.
ECOG performance status 0-2.
For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
Disqualifiers
Absolute neutrophil count ≥ 1.5 x109 / L
Hemoglobin > 9 g/dl
Platelets > 75,000/µl
Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
Trial design
Parallel
Treatments tested in this trial
Atezolizumab
Drugdrugs used outside indication, based on biomarker
Treatment groups
20
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
16 weeks clinical response
To determine percentage of patients who have "not progression" on treatment. "Not progression" is complete response, partial response and stable disease.
Access to drugs for patients
To evaluate percentage of patients included in treatment cohorts
Secondary outcomes
Progression free survival of patients starting treatment in the study
Progression-free survival Time from treatment initiation to progression of disease
Overall survival of patients starting treatment in the study
Time from treatment initiation to death Duration of time on drug Time from the molecular diagnostics first informed consent to starting treatment
Biomarker analyses
• Estimate the percentage of patients eligible for analyses only by liquid biopsies
• Access of tumour tissue biopsy across and within tumour types
• Number of tumour / molecular assessments per patient / cohort
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
Haukeland University Hospital
Collaborator
St. Olavs Hospital
Collaborator
University Hospital of North Norway
Collaborator
University Hospital, Akershus
Collaborator
Vestre Viken Hospital Trust
Collaborator
Hospital of Southern Norway Trust
Collaborator
Ostfold Hospital Trust
Collaborator
The Hospital of Vestfold
Collaborator
Helse Stavanger HF
Collaborator
Nordlandssykehuset HF
Collaborator
Sykehuset Innlandet HF
Collaborator
Helse Forde
Collaborator
Helse Fonna
Collaborator
Helse Nord-Trøndelag HF
Collaborator
Helse Møre og Romsdal HF
Collaborator
Sykehuset Telemark
Collaborator
Lovisenberg Diakonale Hospital
Collaborator