NCT02413827 - A Study of Varlilumab (Anti-CD27) and Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or IV Melanoma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

November 2, 2016

Study Completion Date

November 9, 2016

Conditions

Unresectable Stage III or Stage IV Melanoma

Interventions

DRUG

Combination of varlilumab and ipilimumab

"Eligible patients will receive assigned treatments once every 3 weeks for a total of 4 treatments.~Phase l dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg or 3 mg/kg. Ipilimumab dose is 3 mg/kg."

DRUG

Cohort A: varlilumab & ipilimumab; Cohort B: varlilumab, ipilimumab, CDX-1401 & poly-ICLC

"Eligible patients will receive assigned treatments once every 3 weeks for a total of 4 treatments.~Phase ll dose: The planned dose of varlilumab will be established from Phase I. Ipilimumab dose is 3 mg/kg. Patients assigned to receive CDX-1401 will receive a dose of 1 mg along with 2 mg poly-ICLC."

Trial Locations (8)

15232

University of Pittsburgh Medical Center, Pittsburgh

20007

Georgetown University School of Medicine, Washington D.C.

37203

Tennessee Oncology Sarah Cannon Research Institute, Nashville

60637

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

80045

University of Colorado, Aurora

94115

California Pacific Medical Center Research Institute, San Francisco

95403

Sutter Pacific Medical Foundation, Santa Rosa