Improving Public Cancer Care by Implementing Precision Medicine in Norway

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorOslo University Hospital

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

Qualifiers

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

Treatments tested in this trial

  • Atezolizumab

Treatment groups

3,000 Participants
are divided into 20 treatment groups

20

Treatment groups

See each treatment group below.

Sponsors and collaborators

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