Atezolizumab Monotherapy vs Atezolizumab Plus Cobimetinib in Liver Metastases From Colorectal Cancer
Status:
Withdrawn
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
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.