Table 2

Study endpoints and outcome measures

EndpointsOutcome measures
Primary endpoint
 Progression-free survivalTime from date of randomization until tumor progression or death due to any cause, as confirmed by investigator assessment per RECIST v1.1 or per histopathological confirmation of local tumor progression
Secondary endpoints
 Overall survivalTime from date of randomization until date of death due to any cause
 Progression-free survival (3 year)Proportion of patients alive and progression free at 3 years
 Progression-free survival in programmed death ligand-1 positive patientsTime from date of randomization until tumor progression or death due to any cause, as confirmed by investigator assessment per RECIST v1.1 or per histopathological confirmation of local tumor progression in patients who are programmed death ligand-1 positive
 Objective response ratePercentage of evaluable patients with an investigator-assessed visit response of complete response rate or partial response
 Complete response rateDisappearance of all target and non-target lesions as determined at the 20-week assessment
 Duration of response in patients with complete response rateTime from date of first detection of complete response rate as determined at the 20-week assessment until the date of objective disease progression per RECIST v1.1 or per histopathologic confirmation of local tumor progression
 Incidence of local progression, distant disease progression, and secondary malignancy as the first documented progression eventNumber and percentage of patients who develop local progression, distant disease recurrence, or secondary malignancy
 Health-related quality of lifeChange from baseline in EORTC 30-item Core Quality of Life Questionnaire and EORTC cervical cancer module of the Core Quality of Life Questionnaire
 PharmacokineticsBlood concentration of durvalumab when used in combination with concurrent chemoradiotherapy
 ImmunogenicityPresence of anti-drug antibodies
Safety endpoint
 Safety and tolerabilityAEs, laboratory findings, vital signs, physical examinations
Exploratory endpoints
 Candidate markers likely to correlate with clinical benefitAnalysis of blood/tissue samples to assess exploratory biomarkers, which may include, but is not limited to ctDNA, mRNA signatures, CD8 by IHC, and tumor mutational burden
 Patient-reported outcomesSpecific treatment-related Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events symptoms Patients Global Impression of Change, Patients Global Impression of Severity, and European Organisation for Research and Treatment of Cancer; EuroQoL 5-Dimensional 5-Level Questionnaire
  • AE, adverse event; CD8, cluster of differentiation 8; ctDNA, circulating tumor DNA; DNA, deoxyribonucleic acid; EORTC, European Organisation for Research and Treatment of Cancer; IHC, immunochemistry; mRNA, messenger ribonucleic acid; RECIST, Response Evaluation Criteria in Solid Tumors.