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

Squamous Cell Carcinoma of the Head and Neck (SCCHN) Clinical Trial

Official title:
A Phase l/ll Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 Antibody (Varlilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

Status Completed

Clinical Trial Summary

This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and nivolumab (also known as Opdivo® , BMS-936558). Both drugs target the immune system and may act to promote anti-cancer effects.

Clinical Trial 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.

Nivolumab is a fully human monoclonal antibody that binds to a molecule called PD-1 on immune cells and promotes anti-tumor effects.

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 3 mg/kg of nivolumab. The first phase of the study will test the safety profile of the combination and determine which dose will be studied in Phase ll of the overall study.

During Phase ll, depending on cancer type, groups of patients will be enrolled and 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 nivolumab at 240 mg.

All patients enrolled in the study will be closely monitored to determine if there is response to the treatment as well as for any side effects that may occur. ;

Study Design

Related Conditions & MeSH terms

Carcinoma
Carcinoma, Renal Cell
Colorectal Cancer (CRC)-Enrollment Completed
Glioblastoma
Glioblastoma (GBM) (Phase ll Only)-Enrollment Completed
Ovarian Carcinoma-Enrollment Completed
Renal Cell Carcinoma (RCC) (Phase ll Only)
Squamous Cell Carcinoma of Head and Neck
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Clinical Trial Details

NCT number	NCT02335918
Study type	Interventional
Source	Celldex Therapeutics
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	January 2015
Completion date	December 12, 2018

View Details

See also
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