A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

NCT04185831 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2024-08-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Atezolizumab

PD-L1 inhibitor

DRUG

Everolimus

MTOR inhibitor

DRUG

Cobimetinib

MEK inhibitor

DRUG

Niraparib

PARP inhibitor

Sponsors & Collaborators

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Peter Nygren, MD, PhD · Uppsala University Hospital

  • Peter Asplund, BSc · Uppsala University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2024-01-31
Completion
2024-10-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04185831 on ClinicalTrials.gov