Version: 1.0.0 | Published: 28 Aug 2026 | Updated: 15 days ago
Documentation
Associated Media:
Description:
Recruited patients with metastatic RAS/RAF WT colorectal cancer who 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. Aim was to consent to the study and undergo mandatory baseline biopsy within 3 months of initial progression/ becoming refractory to EGFR blockable.
Nivolumab (480 mg) and Relatlimab (160 mg) started as soon as possible after the baseline biopsy, and administered every 4 weeks.
Mandatory "on-treatment" biopsy at day 21 ± 3 days.
Response assessments in the form of either CT or MRI scans every 8 weeks throughout the study for the 12 months and every 12 weeks from 12 months onwards.
Patients continued on treatment for 24 months OR until progressive disease (PD) confirmed by RECIST 1.1.
At PD participants had further biopsy.
Coverage
Spatial:
Sutton LB, United Kingdom
Typical Age Range:
18-150
Follow Up:
Other
Pathway:
A total of 32 people were screened for the study. Seven were not eligible,
leaving 25 patients who received treatment and were included in the results.
Most participants were men (68%), with a median age of 55 years. All had RAS/RAF
wild-type metastatic colorectal cancer that had previously responded to EGFR
therapy but shown subsequent progression. Started trial treatment within 3
months (as soon as baseline biopsy taken), administered every 4 weeks until
progression or 24mths. CT or MRI scans every 8 weeks throughout the study for
the 12 months and every 12 weeks from 12 months onwards, assessed by RECIST 1.1.
Mandatory biopsies at: Baseline "on-treatment" (day 21 ± 3 days). At progression
Provenance
Origin
Purposes:
Study
Sources:
Other
Collection Situations:
Cohort, study, trial
Temporal
Accrual Periodicity:
Static
Start Date:
27 March 2019
End Date:
30 September 2025
Time Lag:
Not applicable
Accessibility
Access
Access Rights:
in progress
Access Service:
Although not required, there is an option to use The Royal Marsden’s Trusted
Research Environment and informatics platform: BRIDgE (Biomedical Research
Informatics Digital Environment). BRIDgE is managed by The Royal Marsden’s
Information Team with support by the NIHR Biomedical Research Centre at The
Royal Marsden and ICR. The aim of the platform is to transform clinical practice
and improve outcomes for patients by enabling researchers to access real-world
cancer data within secure, collaborative, cloud-based workspaces. Learn more by
visiting the BRIDgE site within the NIHR BRC area of The Royal Marsden and ICR
website: https://www.cancerbrc.org/BRIDgE
Access Request Cost:
Depends on type of access. Costing available on application.
Delivery Lead Time:
Variable
Jurisdictions:
UK
Data Controller:
Royal Marsden NHS Foundation Trust
Data Processor:
Royal Marsden NHS Foundation Trust
Usage
Data Use Limitations:
Research-specific restrictions
Data Use Requirements:
- Institution-specific restrictions
- Ethics approval required
- User-specific restriction
- Not for profit use
Resource Creators:
The Royal Marsden NHS Foundation Trust;
The Royal Marsden Cancer Charity;
NIHR Biomedical Research Centre at The Royal Marsden and the ICR;
Bristol-Myers Squibb.
Format and Standards
Vocabulary Encoding Schemes:
LOCAL
Conforms To:
LOCAL
Languages:
en
Observations
Statistical Population
Population Description
Population Size
Measured Property
Observation Date
Persons
Participants from single hospital. "Observation date" is date of study closure, actual recruitment was over several years
25
30 September 2025