iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer
- Registration Number
- NCT03867799
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
This is a single-arm, single centre open-label, phase II interventional clinical trial of combination immunotherapy with Nivolumab and Relatlimab in mCRC.
- Detailed Description
This is a single-arm, single centre open-label, phase II interventional clinical trial of combination immunotherapy with Nivolumab and Relatlimab in mCRC.
Patients with metastatic RAS/RAF WT colorectal cancer who have previously had a radiological response to EGFR inhibitors i.e. Cetuximab or Panitumumab, either combined with chemotherapy or as single agents, but subsequently experienced progression of their disease will be eligible for the study. They will consent to the study ideally within 3 months having progressed/ become refractory to EGFR blockable and undergo a mandatory baseline biopsy within this time period.
Patients will receive Nivolumab and Relatlimab every 4 weeks and will start on study treatment as soon as possible after the baseline biopsy. 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. Patients 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nivolumab and Relatlimab Nivolumab Nivolumab 480mg and Relatlimab 160mg will be administered intravenously every 4 weeks
- Primary Outcome Measures
Name Time Method Disease Control Rate (DCR) 6 months from treatment initiation
- Secondary Outcome Measures
Name Time Method NCI CTCAE version 5.0 toxicity within 30 days of the last dose of study treatment Disease Control Rate (DCR) 12 and 24 months Duration of disease control 6, 12 and 24 months Best Objective Response Rate 6, 12 and 24 months Progression Free Survival Time from registration to progression (radiological or clinical) or death at 6 months, 12 months and 24 months Overall survival time from registration to death from any cause at 6 months, 12 months and 24 months
Trial Locations
- Locations (1)
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom