CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 3,000 target
Drug / intervention
Atezolizumabdrug
Likely dose
Not stated in record
Key inclusion· 8
  • Pathology-proven locally advanced or metastatic malignant disease no longer benefitting from standard treatment or for which no standard treatment is available/indicated
  • Measurable or evaluable disease per RECIST v1.1, IMWG, CHESON/Lugano, RANO, iRECIST, or IWG criteria depending on tumor type
  • Genomic profile with actionable variant or protein overexpression for which an approved targeted therapy in the study has potential clinical benefit
  • Genomic/molecular test from preapproved laboratory; may be performed on fresh or paraffin-embedded tumor specimen or cell-free DNA from liquid biopsy
Key exclusion· 15
  • Eligible for other ongoing trials with equal or greater potential benefit where access is manageable
  • Ongoing toxicity >CTCAE grade 2 related to prior anti-tumor treatment completed within 4 weeks, or peripheral neuropathy ≥CTCAE grade 3
  • Progressive brain metastases or declining neurologic function; treated/stable brain metastases are eligible
  • For GBM patients: requirement for enzyme-inducing antiepileptic drugs (EIAED); must switch to non-EIAED at least 2 weeks prior to randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04817956
NCT04817956Phase 2RecruitingHigh MomentumUpdated 28mo ago
Long Recruiting

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

Oslo University Hospital·interventional·Posted Mar 26, 2021·Updated Feb 29, 2024

In Brief

A Phase 2 clinical trial evaluating Atezolizumab for Cancer Metastatic. Currently recruiting, targeting 3,000 participants across 17 sites.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Timeline

Phase 2Recruiting
20212022202320242025202620272028202920302031203220332034203520362037203820392040204120422043204420452046
First PostedMar 26, 2021
Enrollment StartApr 1, 2021
Primary CompletionMar 30, 2040
Study CompletionApr 30, 2045
TodayJul 2, 2026
Enrollment to primary: 19.0 yearsPosted 5.3 years agoPrimary completion in 13.7 years

Interventions

Atezolizumabdrug

drugs used outside indication, based on biomarker