Colorectal Cancer Metastatic Clinical Trial
Official title:
Phase II Trial of Nivolumab and Metformin in Patients With Treatment Refractory MSS Metastatic Colorectal Cancer
This phase II trial studies how well nivolumab and metformin work in treating patients with microsatellite stable (MSS) stage IV colorectal cancer that has not responded to previous treatment. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Metformin is an antidiabetic drug that and may reduce the risk of colorectal cancer development in patients. Giving nivolumab and metformin may work better in treating patients with refractory microsatellite metastatic colorectal cancer.
PRIMARY OBJECTIVE: I. To evaluate the effect of nivolumab and metformin combination on the overall response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. SECONDARY OBJECTIVES: I. To determine the effect of nivolumab and metformin combination on clinical outcomes, progression free survival and overall survival, and biochemical response (CEA). II. To compare the effect of nivolumab and metformin combination on immune and metabolic biomarkers in the tumor microenvironment and systemic circulation (pre and post treatment paired biopsies required). OUTLINE: Patients receive metformin PO BID starting on day 1. After 14 days of metformin only period patients also receive nivolumab IV every 4 weeks starting on day 15. Courses repeat every 28 days for up to 2 years in the absence of disease progression, unacceptable toxicity or consent withdrawal After completion of study treatment, patients are followed up at day 30 and then periodically thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03941080 -
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
|
||
| Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
| Completed |
NCT03647839 -
Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT05057052 -
Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis
|
Phase 2 | |
| Terminated |
NCT02316496 -
Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study
|
Phase 2 | |
| Completed |
NCT03251612 -
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT02380443 -
AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT02149784 -
Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients
|
Phase 3 | |
| Recruiting |
NCT01959061 -
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
|
Phase 4 | |
| Terminated |
NCT01668680 -
Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma
|
Phase 2 | |
| Recruiting |
NCT05068531 -
Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
|
||
| Not yet recruiting |
NCT04525807 -
Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
|
||
| Completed |
NCT04482608 -
The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
|
||
| Recruiting |
NCT03193710 -
The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved
|
N/A | |
| Recruiting |
NCT04854213 -
PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients With LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells)
|
N/A | |
| Suspended |
NCT04108481 -
Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03142516 -
FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status
|
Phase 2 | |
| Completed |
NCT03144804 -
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01910610 -
Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer
|
Phase 3 | |
| Recruiting |
NCT05759728 -
A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer
|
Phase 1/Phase 2 |