Atezolizumab Monotherapy vs Atezolizumab Plus Cobimetinib in Liver Metastases From Colorectal Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Niharika Mettu
Study ID
NCT03340558
Phase
PHASE2
Status
Withdrawn

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Atezolizumab — BIOLOGICAL
    Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1.
  • Cobimetinib — DRUG
    MEK inhibitor

Study Details

This study is for patients with metastatic colorectal cancer who are candidates for resection of metastases. This study will be conducted sequentially with 2 cohorts: 1.) Monotherapy Cohort and 2.) Combination Cohort Pre-metastatectomy * Monotherapy Cohort: The first 10 subjects will receive Atezolizumab 840 mg IV on Day 1 and Day 15 of each 28-day cycle. * Combination Cohort: The next 15 subjects will receive Atezolizumab 840 mg IV on Day 1 and Day 15 and Cobimetinib 60 mg PO on Days 1-21 of each 28-day cycle. Note: Cobimetinib must be held for the 7 days prior to metastatectomy. All subjects will be treated for 2 cycles (8 weeks) prior to metastatectomy Metastatectomy Subjects will undergo liver metastatectomy within 42 days of completion of Cycle 2 of pre-metastatectomy treatment. No study treatment is administered while the patient is healing after surgery. Post-metastatectomy Once the patient has healed from the surgery, adjuvant treatment may be administered at the discretion of the treating physician. Restaging following standards of care for this setting.

Key Dates

Start date
May 31, 2018
Status verified
Oct 2018
Primary completion
Feb 28, 2021
Completion
Feb 28, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Monotherapy Cohort
    The first 10 subjects will receive Atezolizumab 840 mg IV on Day 1 and Day 15 of each 28-day cycle. Subjects will be treated for 2 cycles before undergoing metastatectomy within 42 days of completion of Cycle 2. No study treatment is administered while subjects are healing after surgery.
  • Experimental: Combination Cohort
    The next 15 subjects will receive Atezolizumab 840 mg IV on Day 1 and Day 15 and Cobimetinib 60 mg PO on Days 1-21 of each 28-day cycle. Cobimetinib must be held for the 7 days prior to metastatectomy. Subjects will be treated for 2 cycles before undergoing metastatectomy within 42 days of completion of Cycle 2.

Primary Outcome Measure

Change in CD4 T cell immune infiltrates [ Time Frame: Subject tissue will be assessed pre-treatment (baseline) and post-treatment within 42 days after completion of Cycle 2 using metastatectomy tissue. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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