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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Atezolizumab

    Drug

    drugs used outside indication, based on biomarker

Treatment groups

3,000 Participants
are divided into 20 treatment groups

20

Treatment groups

See each treatment group below.

Group A: AtezolizumabExperimental treatment 1 intervention
Group B: Atezilizumab combined with bevacizumabExperimental treatment 1 intervention
Group C: Phesgo (trastuzumab og pertuzumab)Experimental treatment 1 intervention
Group D: AlectinibExperimental treatment 1 intervention
Group E: vismodegibExperimental treatment 1 intervention
Group F: entrectinibExperimental treatment 1 intervention
Group G: Zelboraf + CotellicExperimental treatment 1 intervention
Group H: AlpelisibExperimental treatment 1 intervention
Group I: Dabrafenib + trametinibExperimental treatment 1 intervention
Group J: MelfalanExperimental treatment 1 intervention
Group K: PemazyreExperimental treatment 1 intervention
Group L: SelpercatinibExperimental treatment 1 intervention
Group M: OlaparibExperimental treatment 1 intervention
Group N: CapmatinibExperimental treatment 1 intervention
Group O: ImatinibExperimental treatment 1 intervention
Group P: BortezomibExperimental treatment 1 intervention
Group Q: Actinomycin DExperimental treatment 1 intervention
Group R: NiraparibExperimental treatment 1 intervention
Group S: DostarlimabExperimental treatment 1 intervention
Group T: CeritinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
16 weeks
2

Access to drugs for patients

To evaluate percentage of patients included in treatment cohorts

Time frame
4 years

Secondary outcomes

1

Progression free survival of patients starting treatment in the study

Progression-free survival Time from treatment initiation to progression of disease

Time frame
4 years
2

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

Time frame
4 years
3

Biomarker analyses

• Estimate the percentage of patients eligible for analyses only by liquid biopsies

Time frame
4 years
4

• Access of tumour tissue biopsy across and within tumour types

• Number of tumour / molecular assessments per patient / cohort

Time frame
4 years

Other outcomes

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