A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

August 31, 2017

Study Completion Date

November 3, 2017

Conditions
Carcinoma, Renal CellKidney DiseasesKidney NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsNeoplasmsNeoplasms by Histologic TypeClear-cell Metastatic Renal Cell Carcinoma
Interventions
DRUG

Combination of varlilumab and sunitinib

"During the treatment phase of the study, eligible patients will receive varlilumab for up to 8 cycles. Treatment cycles are 6 weeks each with varlilumab administered once every 3 weeks and sunitinib administered daily for 4 weeks followed by a 2 week rest. There is no limit on the number of cycles of sunitinib. Patients may be discontinued from receiving study treatment (sunitinib or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable.~Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg or 3 mg/kg.~The Study was terminated prior to initiation of Phase II.~All patients will receive sunitinib at a dose of 50 mg."

Trial Locations (9)

10029

Mount Sinai Medical Center, New York

19107

Thomas Jefferson University, Philadelphia

20037

George Washington University-Medical Faculty Associates, Washington D.C.

35294

University of Alabama at Birmingham, Birmingham

48109

University of Michigan, Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute, Detroit

68130

Nebraska Cancer Specialists, Omaha

94158

UCSF Helen Diller Comprehensive Cancer Center, San Francisco

95817

UC Davis Comprehensive Cancer Center, Sacramento

Sponsors
All Listed Sponsors
lead

Celldex Therapeutics

INDUSTRY

NCT02386111 - A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma | Biotech Hunter | Biotech Hunter