Cancer types
Title of study
A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated,Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
Version Number
Approval Date 
4, 26 April 2019
Short Title
Checkmate
Study site
Principle Investigator
L. Hendriks (MUMC)
Investigator Maastro
D. DeRuysscher
Sponsor
Bristol-Myers Squibb
Trial registry
Objectives 

Primary:
To compare the efficacy of nivolumab+ CCRT followed by nivolumab + ipilimumab (Arm A) vs CCRT followed by durvalumab(Arm C)in participants with untreated LA NSCLC
Secondary:
– To compare the efficacy of nivolumab+ CCRT followed by nivolumab + ipilimumab (Arm A) or nivolumab+ CCRT followed by nivolumab alone(Arm B)as maintenance vs CCRT followed by durvalumab(Arm C)in participants with untreated LA NSCLC
– To assess safety and tolerability
– To compare the efficacy of nivolumab+ CCRT followed by nivolumab + ipilimumab (Arm A) or nivolumab+ CCRT followed by nivolumab alone(Arm B)as maintenance vs CCRT followed by durvalumab(Arm C)in participants with untreated LA NSCLC
Exploratory:
– To characterize changes in cancer-related symptoms and quality-of-life in patients with untreated LA NSCLC
– To evaluate psychometric measurement properties of the LCS sub-scale of FACT-L and NSCLC-SAQ
– To evaluate the tolerability of nivolumab+ CCRT followed by nivolumab + ipilimumab (Arm A) or nivolumab+ CCRT followed by nivolumab alone(Arm B)as maintenance vs CCRT followed by durvalumab(Arm C)in participants with untreated LA NSCLC
– To evaluate investigator-assessed outcomes on next-line therapies
– To evaluate candidate biomarkers as potential predictive biomarkers of efficacy
– To characterize the pharmacokinetics (PK) of ipilimumab and nivolumab when administered in combination or for nivolumab when administered alone as monotherapy
– To assess immunogenicity of nivolumab monotherapy and nivolumab and ipilimumab combination therapy – To assess healthcare resource utilization(HCRU) in each treatment arm

Primary Endpoint 

PFS by RECIST1.1 per Blinded Independent Central Review (BICR) for ArmA vs Arm C – OS for Arm A vs Arm C

Secondary Endpoints 

– OS for Arm B vs Arm C
– PFS by RECIST 1.1 per BICR for Arm B vs Arm C
– Objective Response Rate (ORR) and Complete Response Rate by RECIST1.1 (BICR)
– Duration of Response(DoR)by RECIST1.1 per BICR – Time to Response by RECIST1.1 per BICR
– Time to death or distant metastases (TTDM) using BICR assessments according to RECIST1.1