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)

PHASE2CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

September 14, 2015

Primary Completion Date

April 29, 2024

Study Completion Date

April 29, 2024

Conditions
Bladder CancerMelanoma
Interventions
DRUG

Nivolumab

"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"

DRUG

Nivolumab plus Ipilimumab

"Combination Treatment~* Ipilimumab 3 mg/kg~* Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses"

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

18103

Lehigh Valley Health Network, Allentown

06030

University of Connecticut Health Center, Farmington

07748

Memorial Sloan Kettering Monmouth, Middletown

All Listed Sponsors
collaborator

UConn Health

OTHER

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Adaptive Biotechnologies

INDUSTRY

collaborator

MedGenome

UNKNOWN

lead

Memorial Sloan Kettering Cancer Center

OTHER