Improving Public Cancer Care by Implementing Precision Medicine in Norway

Sponsor
Oslo University Hospital
Study ID
NCT04817956
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    drugs used outside indication, based on biomarker

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Feb 2024
Primary completion
Mar 30, 2040
Completion
Apr 30, 2045

Study Design

Enrollment
3,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    Atezolizumab used outside of current indication, based on biomarkers
  • Experimental: Atezilizumab combined with bevacizumab
    Atezilizumab combined with bevacizumab used outside of indication, based on biomarkers
  • Experimental: Phesgo (trastuzumab og pertuzumab)
    Phesgo used outside of indication, based on biomarkers.
  • Experimental: Alectinib
    Alectinib used outside of indication, based on biomarker
  • Experimental: vismodegib
    vismodegib used outside of indication, based on biomarker
  • Experimental: entrectinib
    entrectinib used outside of indication, based on biomarker
  • Experimental: Zelboraf + Cotellic
    Zelboraf + Cotellic used outside of indication, based on biomarker
  • Experimental: Alpelisib
    Alpelisib used outside of indication, based on biomarker
  • Experimental: Dabrafenib + trametinib
    Used outside of indication, based on biomarker
  • Experimental: Melfalan
    Melfalan used outside ofcurrent indication
  • Experimental: Pemazyre
    Pemazyre used outside ofcurrent indication
  • Experimental: Selpercatinib
    used outside ofcurrent indication
  • Experimental: Olaparib
    Used outside of current indication, for patients with bi-allelic BRCA-inactication
  • Experimental: Capmatinib
    Used outside of current indication,
  • Experimental: Imatinib
    Used outside of current indication,
  • Experimental: Bortezomib
    Used outside of current indication,
  • Experimental: Actinomycin D
    Used outside of current indication,
  • Experimental: Niraparib
    Used outside of current indication,
  • Experimental: Dostarlimab
    Used outside of current indication
  • Experimental: Ceritinib
    Used outside of current indication

Primary Outcome Measure

16 weeks clinical response [ Time Frame: 16 weeks ]

Central Contacts

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