At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 81 enrolled
Drug / intervention
Nivolumab +1 moredrug
Likely dose
Nivolumab 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospectively Designed Study to Assess the Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)
In Brief
A Phase 2 clinical trial evaluating Nivolumab and Nivolumab plus Ipilimumab for Bladder Cancer and Melanoma. Completed, enrolled 81 participants across 5 sites.
Detailed Summary
The purpose of this study is to investigate the characteristics of tumors in patients treated with nivolumab and to identify features that help to predict a good or bad response to this drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer, Melanoma
CountriesUnited States
CollaboratorsUConn Health, Bristol-Myers Squibb, Adaptive Biotechnologies, MedGenome
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedSep 2015
Primary CompletionApr 2024
TodayJul 2026
First PostedSep 17, 2015
Enrollment StartSep 14, 2015
Primary CompletionApr 29, 2024
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 10.8 years ago
Interventions
Nivolumabdrug
Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks OR \- Nivolumab 480 mg flat dose Dosed q 4 weeks for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit
Nivolumab plus Ipilimumabdrug
Combination Treatment * Ipilimumab 3 mg/kg * Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses