A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

Sponsor
Uppsala University Hospital
Study ID
NCT04185831
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    PD-L1 inhibitor
  • Everolimus — DRUG
    MTOR inhibitor
  • Cobimetinib — DRUG
    MEK inhibitor
  • Niraparib — DRUG
    PARP inhibitor

Study Details

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.

Key Dates

Start date
Oct 20, 2020
Status verified
Aug 2024
Primary completion
Jan 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
167 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NF1/MAP2K1
    Cobimetinib, 60mg po daily. 28 day cycle; day 1-21 60mg daily, day 22-28 rest period.
  • Experimental: MTOR/TSC1/TSC2
    Everolimus, 10mg po daily.
  • Experimental: Mutation burden
    Atezolizumab. 1200mg iv every 3 weeks.
  • Experimental: PPARi
    Niraparib. 300mg po daily.

Primary Outcome Measure

Objective Response Rate (ORR) and tumor control rate [Time Frame: From first dose up to 24 months] [ Time Frame: 1 year follow-up after LPFV ]

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