Clinical Trials Logo

Clinical Trial Summary

A single institution study to evaluate the safety and tolerability of the combination treatment of nivolumab, ipilimumab, CMP-001 and radiosurgery in patients with metastatic colorectal cancer with liver metastases.


Clinical Trial Description

Patients will be treated with radiosurgery to liver metastases (completed by day 1), followed by a priming dose of subcutaneous CMP-001 (day 1 ± 4 days), intratumoral injections of CMP-001 on days 13, 36 and 55, combined with nivolumab 3mg/kg every 2 weeks (start day 15) and ipilimumab 1 mg/kg every 6 weeks (start day 15). From day 71 biweekly subcutaneous injections of CMP-001 will commence. Nivolumab, ipilimumab and subcutaneous injections of CMP-001 will be continued until disease progression or up to 24 months in the absence of disease progression or unacceptable toxicity. Two research biopsies will be taken from a liver metastasis. The first biopsy will be taken during the screening period (pretreatment) and the second one 5 weeks post-radiosurgery (which is 3 weeks post-initiation of nivolumab / ipilimumab). As a safety run-in, the initial cohort of 3-6 patients will not receive radiosurgery. The next cohort will not commence until the last patient from the initial cohort has been followed up for at least 8 weeks post first intratumoral injection. Efficacy endpoints will be based upon a non-irradiated lesion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03507699
Study type Interventional
Source Sheba Medical Center
Contact
Status Completed
Phase Phase 1
Start date December 15, 2018
Completion date May 25, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Recruiting NCT05057052 - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis Phase 2
Recruiting NCT06120127 - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence Phase 2
Recruiting NCT04837885 - Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases Phase 2
Terminated NCT04589884 - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Not yet recruiting NCT04520737 - Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases N/A
Terminated NCT02465112 - Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor Phase 3
Completed NCT02352259 - Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II Phase 2
Active, not recruiting NCT01763450 - Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer Phase 2
Withdrawn NCT01631539 - Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC N/A
Recruiting NCT01250158 - Liver-PILP First-in-Man N/A
Terminated NCT01233544 - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases Phase 3
Completed NCT01347333 - Stereotactic Body Radiotherapy for Liver Tumors N/A
Completed NCT00587756 - Alternative to Two-Stage Hepatectomy N/A
Completed NCT01683357 - Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases N/A
Completed NCT04942665 - Low Dose ICG for Biliary Tract and Tumor Imaging Phase 2
Not yet recruiting NCT05354674 - Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Recruiting NCT04616495 - Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Not yet recruiting NCT04509635 - Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis Phase 3
Recruiting NCT04178759 - Impact of Chemotherapy and Regenerative Markers of Liver Regeneration After Liver Resection for Liver Metastases N/A