iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03867799|
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Nivolumab||Phase 2|
This is a single-arm, single centre open-label, phase II interventional clinical trial of combination immunotherapy with Nivolumab and Relatlimab in mCRC.
Participants with metastatic RAS/RAF WT colorectal cancer who have previously had a radiological response to standard first line therapy with FOLFIRI and Cetuximab but subsequently experienced progression of their disease will be eligible for the study. They will consent to the study within 4 weeks of having progressed/ become refractory to FOLFIRI and Cetuximab and undergo a mandatory baseline biopsy within this time period.
Participants will receive Nivolumab and Relatlimab every 4 weeks. After starting on the study drugs, there will be a mandatory 'on-treatment' biopsy at day 21 ± 3 days. Response assessments in the form of either CT or MRI scans will take place every 8 weeks throughout the study for the 12 months and every 12 weeks from 12 months onwards. Participants will continue on the study until progressive disease (PD) is confirmed by RECIST 1.1 or when maximum duration of treatment of 24 months has been reached.
There will be the possibility of 'treating beyond progression' if participants are deriving clinical benefit from treatment to encompass the possibility of pseudoprogression. At PD participants will undergo a further biopsy. The investigators envisage enrolling a total of 25 participants and the investigators anticipate 30 months as a feasible time frame for accrual.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunotherapy Sequencing in COlon and REctal Cancer|
|Actual Study Start Date :||March 27, 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: Nivolumab and Relatlimab
Nivolumab 480mg and Relatlimab 160mg will be administered intravenously every 4 weeks
Other Name: Relatlimab
- Disease Control Rate (DCR) [ Time Frame: 6 months from treatment initiation ]
- NCI CTCAE version 5.0 toxicity [ Time Frame: within 30 days of the last dose of study treatment ]
- Disease Control Rate (DCR) [ Time Frame: 12 and 24 months ]
- Duration of disease control [ Time Frame: 6, 12 and 24 months ]
- Best Objective Response Rate [ Time Frame: 6, 12 and 24 months ]
- Progression Free Survival [ Time Frame: Time from registration to progression (radiological or clinical) or death at 6 months, 12 months and 24 months ]
- Overall survival [ Time Frame: time from registration to death from any cause at 6 months, 12 months and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867799
|The Royal Marsden NHS Foundation Trust||Recruiting|
|London, United Kingdom, SW3 6JJ|
|Contact: Richard Crux 02086613807 email@example.com|
|Sub-Investigator: Fiona Turkes|
|Principal Investigator: Naureen Starling|