drugset / Trial / NCT04185831
A MolEcularly Guided Anti-Cancer Drug Off-Label Trial
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, open-label, non-randomized combined basket- and umbrella trial divided in two parts; a limited feasibility-oriented part 1 including 154 patients and 3 treatment cohorts and part 2 that will include an expanded cohort of patients and treatment cohorts. The overall aims of the study are to test the feasibility, safety and efficacy of comprehensive genomic profiling on fresh tumor biopsies as a basis for treatment decision making and to compare two different sequencing, bioinformatics and decision-making platforms (part 1). Also to evaluate the efficacy and safety of off-label treatment with cancer drugs in patients selected based on genomic biomarker matching.
Timeline
- Start
- 2020-10-20
- Primary completion
- 2024-01-31
- Completion
- 2024-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Cobimetinib | Small molecule | 60 mg | Oral |
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Niraparib | Small molecule | 300 mg | Oral |