A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Celldex Therapeutics
Study ID
NCT02543645
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Combination of Varlilumab and Atezolizumab — DRUG
    Treatment cycles are 12 weeks each with varlilumab and atezolizumab administered every 3 weeks. During the treatment phase of the study, eligible patients will receive varlilumab for up to 3 cycles (with a 4th cycle possible following discussion with the Medical Monitor). There is no limit on the number of cycles of atezolizumab. Patients may be discontinued from receiving study treatment (atezolizumab 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 dose of atezolizumab is 1200 mg.

Study Details

This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll patients with a number of tumor types; Phase ll will enroll only patients with renal cell carcinoma (RCC).\* \*Note: This Study was terminated prior to initiation of Phase II

Key Dates

Start date
Oct 31, 2015
Status verified
Apr 2018
Primary completion
Apr 30, 2017
Completion
May 22, 2017

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Varlilumab and Atezolizumab

Primary Outcome Measure

Phase l: Safety and tolerability of varlilumab in combination with atezolizumab as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities. [ Time Frame: Safety follow-up is 70 days from last study drug dose. ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California - San FranciscoSan FranciscoCalifornia94550-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-

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By research site
University of California - San Francisco· San Francisco, CABeth Israel Deaconess Medical Center· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYDuke University Medical Center· Durham, NC

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