NCT04817956

Improving Public Cancer Care by Implementing Precision Medicine in Norway

Improving Public Cancer Care by Implementing Precision Medicine in Norway A Multi-cohort Phase 2 Treatment Clinical Study Investigating Efficacy of Approved Drugs Outside Indication in Patients With Advanced Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Eligible patients have an advanced malignancy already treated with standard treatment, acceptable performance status and organ function, with no other suitable clinical trial available in Norway. A molecular test performed at a study specific reference laboratory has identified a potentially targetable molecular profile. Next, a suitable drug should be available from the trial drug armamentarium. Finally, if the patient fulfils the inclusion criteria and is accepted for the trial, a second tumour biopsy (snap-frozen)/ tumour material for WGS will be sampled. Patients enrolled in the study will enter an existing cohort, or, in case a suitable cohort does not exist, a new cohort can be opened. One cohort will consist of one diagnostic subgroup, one drug (or one drug-combination) and one molecular marker. The choice of drug(s) will be supported by a list of potential profiles. In addition, available knowledge from the literature will be used to prepare discussion in a national molecular tumour board, which will provide a treatment recommendation to the treating physician and the study doctors . The protocol-specified treatment may be administered to the patient once drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future biomarker studies and research on responders versus non-responders. All patients who receive treatment with a drug available in the protocol will be monitored for standard efficacy outcomes including tumour response, progression-free and overall survival as well as study specific measures as duration of treatment. Patients that are screened, but not included into any cohorts will be followed for 16 weeks for survival and clinical course of disease. Treatment-related toxicities (CTCAE grade 3-5) will be evaluated. Study-specific treatment and outcome data including results from the molecular screening will be reported to the Cancer Registry of Norway. Long-term follow up data using the Cancer Registry of Norway and information from The Norwegian Patient Registry, The Norwegian Prescription Database and Primary patient- and user Register (KPR) will be collected on all patients screened.

Conditions

• Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Atezolizumab	drugs used outside indication, based on biomarker

Timeline

• Start date: 2021-04-01
• Primary completion: 2040-03-30
• Completion: 2045-04-30
• First posted: 2021-03-26
• Last updated: 2024-02-29

Locations

17 sites across 1 country: Norway