NCT02837263

PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer

Pembrolizumab in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 1b feasibility study to evaluate the use of PD-1 blockade in combination with ablative radiotherapy for the treatment of metastatic colorectal cancer (CRC). This study will examine the sequential combination of stereotactic body radiotherapy (SBRT) and pembrolizumab for patients for whom the goal is eradicating all known sites of disease. It is very likely that for many patients the SBRT therapy will be completed following other modalities including operative resection or ablation.

Conditions

• Colorectal Cancer
• Colorectal Adenocarcinoma
• Stage IVA Colorectal Cancer
• Stage IVB Colorectal Cancer
• Metastatic Carcinoma in the Liver

Interventions

Type	Name	Description
RADIATION	Stereotactic body radiotherapy (SBRT)	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.
DRUG	Pembrolizumab	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 ipilumumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Timeline

• Start date: 2016-08-11
• Primary completion: 2021-11-02
• Completion: 2023-05-31
• First posted: 2016-07-19
• Last updated: 2023-06-12

Locations

1 site across 1 country: United States