A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

December 12, 2018

Study Completion Date

December 12, 2018

Conditions
Squamous Cell Carcinoma of the Head and Neck (SCCHN)Ovarian Carcinoma-Enrollment CompletedColorectal Cancer (CRC)-Enrollment CompletedRenal Cell Carcinoma (RCC) (Phase ll Only)Glioblastoma (GBM) (Phase ll Only)-Enrollment Completed
Interventions
DRUG

Combination of varlilumab and nivolumab

"Phase I: Varlilumab dosing will be dependent on the cohort assigned in combination with 3 mg/kg of nivolumab every two weeks.~Phase II: Patients with CRC, RCC or GBM enrolled in Phase ll will receive 3.0 mg/kg of varlilumab in combination with 240 mg of nivolumab every 2 weeks. Patients with SCCHN or ovarian cancer will receive varlilumab at a dose of either 3 mg/kg every 2 weeks, 3 mg/kg every 12 weeks, or 0.3 mg/kg every 4 weeks, in combination with 240 mg of nivolumab every 2 weeks.~Patients may be discontinued from receiving study treatment based on the results of disease assessments or if experiencing intolerable side effects."

Trial Locations (19)

10016

Laura and Isaac Perlmutter Cancer Center, New York

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

20007

Georgetown University, Washington D.C.

20037

George Washington University School of Medicine and Health Sciences, Washington D.C.

22031

Inova Schar Cancer Institute Research, Fairfax

27157

Wake Forest Baptist Health, Winston-Salem

30060

Northwest Georgia Oncology Centers PC, Marietta

33140

Mount Sinai Medical Center, Miami Beach

44195

Cleveland Clinic, Cleveland

46845

Parkview Research Center, Fort Wayne

48201

Barbara Ann Karmanos Cancer Institute, Detroit

80045

University of Colorado Medical Center, Aurora

85719

University of Arizona Cancer Center, Tucson

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

94304

The Stanford Center for Clinical and Translational Education and Research, Palo Alto

97213

Providence Health & Services, Portland

06519

Smilow Cancer Hospital at Yale University Cancer Center, New Haven

02115

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Celldex Therapeutics

INDUSTRY