At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic colorectal cancer to the liver only (no other sites of metastatic disease)
- ✓Tumor must be MMR-proficient (MSI-stable/low or intact MMR proteins on IHC)
- ✓Candidate for SBRT to at least one intrahepatic lesion
- ✓Surgical candidate with goal of eradicating all known disease with one additional surgery
- ✕Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
- ✕Prior anti-cancer monoclonal antibody within 4 weeks of Day 1 or unrecovered from adverse events
- ✕Chemotherapy, targeted therapy, or radiation within 2 weeks of Day 1 (prior liver radiotherapy not allowed)
- ✕Known active CNS metastases or carcinomatous meningitis (resected brain metastases allowed if ≥6 months prior with no CNS progression)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pembrolizumab in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer
In Brief
A Phase 1 clinical trial evaluating Stereotactic body radiotherapy (SBRT) and Pembrolizumab for Colorectal Cancer and 4 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The purpose of this research study is: * To find out how safe the study drug, pembrolizumab, is when combined with stereotactic body radiotherapy (SBRT) to the liver. * To see how well subjects can tolerate treatment with pembrolizumab and SBRT. * To find out how often colorectal cancer comes back 1 year after surgically removing all known disease and being treated with SBRT and pembrolizumab.
Study Details
Timeline
Interventions
SBRT treatment will consist of 40-60 Gy delivered in five fractions prescribed to the planning target volume (PVT). Image guidance with MRI, megavoltage CT or cone beam CT scans would be required. SBRT will be initiated on Day 0. This should be initiated within 4 weeks of signing informed consent. An additional 2 weeks will be allowed if necessary due to SBRT treatment planning.
Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. KeytrudaTM (pembrolizumab) has recently been approved in the United Stated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipiliumumab and, if BRAF V600 mutation positive, a BRAF inhibitor.