NCT02543645

A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer

A Phase l/ll, Open Label, Dose-escalation Study of Varlilumab (CDX-1127) in Combination With Atezolizumab (MPDL3280A, Anti-PD-L1) in Patients With Advanced Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects. Atezolizumab is an engineered anti-PD-L1 antibody. This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with atezolizumab. Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 1200 mg of atezolizumab. The first phase of the study will enroll up to 18 patients and test the safety profile of the combination of varlilumab and atezolizumab in patients with various tumor types and determine which dose of varlilumab will be studied in Phase ll\* of the study which will enroll only patients with RCC. \*Note: This Study was terminated prior to initiation of Phase II. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

Conditions

• Carcinoma, Renal Cell
• Kidney Diseases
• Kidney Neoplasms
• Urogenital Neoplasms
• Urologic Diseases
• Urologic Neoplasms
• Neoplasms by Histologic Type
• Neoplasms
• Clear-cell Metastatic Renal Cell Carcinoma
• Melanoma
• Triple Negative Breast Cancer
• Bladder Cancer
• Head and Neck Cancer
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Combination of Varlilumab and Atezolizumab	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-04-01
• Completion: 2017-05-22
• First posted: 2015-09-07
• Last updated: 2018-04-30

Locations

4 sites across 1 country: United States