NCT02386111

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

A Phase l/ll Study of Varlilumab in Combination With Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (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 sunitinib. The study will enroll patients with metastatic clear cell renal cell carcinoma.

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. Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) some of which play a role in tumor growth and progression of cancer. This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with sunitinib. 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 50 mg of sunitinib. The first phase of the study will test the safety profile of the combination and determine which dose of varlilumab will be studied in Phase ll\* of the overall study. \*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
• Neoplasms by Histologic Type
• Clear-cell Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-08-01
• Completion: 2017-11-03
• First posted: 2015-03-11
• Last updated: 2018-07-26

Locations

9 sites across 1 country: United States