Clinical Trials Logo

Clinical Trial Summary

This study aims to determine the efficacy, safety, and tolerability of the sequential addition of immune-modulating therapy to standard-of-care therapy of microsatellite-stable (MSS)/mismatch repair-proficient (pMMR) metastatic colorectal cancer (mCRC).


Clinical Trial Description

Hypothesis: Patients with MSS/pMMR-mCRC harbor tumor that can be transformed into an immunogenic disease by short-course oxaliplatin-based therapy, and may thereby benefit from the addition of immune-modulating therapy to improve outcome of the current oxaliplatin-based standard-of-care. Primary objective: To determine progression-free survival (PFS), in terms of failure of treatment strategy, of sequential treatment with the Nordic FLOX (5-Fluorouracil, oxaliplatin and leucovorin) regimen and nivolumab compared with the standard-of-care Nordic FLOX regimen in previously untreated MSS/pMMR-mCRC. Secondary objectives: To determine safety and tolerability of sequential treatment with the Nordic FLOX regimen and nivolumab compared with the standard-of-care Nordic FLOX regimen. To monitor and compare quality-of-life (QoL) alterations during therapy courses. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03388190
Study type Interventional
Source University Hospital, Akershus
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 29, 2018
Completion date June 30, 2025

See also
  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 NCT03144804 - A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer 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
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