West Cancer Center

HEAD AND NECK: PHASE 1: Combo Immunotherapy: "CA223-001:

A phase 1 dose escalation and cohort expansion study of the safety, tolerability and efficacy of anti-KIR (lirilumab) administered in combination with anti-PD-1 (nivolumab) in advanced refractory solid tumors (CA223-001)

Title

Bristol-Myers Squibb CA223-001

Study Title

Site Link

NCT01714739

Malignancy

Head and Neck Cancer (Larynx, Oral cavity, Oropharynx, Hypopharynx), SCCHN

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line or later

Investigational Agent

Nivolumab, Lirilumab

Drug Class

PD-1 inhibitor, anti-KIR antibody

Moon Fenton, MD, PhD

Sponsor

Bristol-Myers Squibb

Phase

Phase 1

Status

Temporarily On Hold

Key Eligibility Criteria

NCT01714739

Key Eligibility Criteria Details

Histologically confirmed incurable locally advanced, recurrent or metastatic SCCHN stage III/IV and not amenable to local therapy with curative intent (surgery or XRT with or without chemo)
Confirmation of tumor HPV status
Tumor progression or recurrence within 6 months of last dose of platinum therapy in either the adjuvant, primary, recurrent, or metastatic setting
Measurable disease by RECIST
ECOG PS 0-1
No known CNS mets
No prior or concurrent malignancies
No history of autoimmune disorders
No prior tx with PD-1, anti-KIR, or anti-CTLA4 therapy
No RANK-L inhibitors within 10 weeks, no bisphosphonates within 4 weeks
No known HIV/HBV/HCV

Objective

Primary- Safety; Secondary- ORR, DOR, PFS, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Squamous cell carcinoma

Dosing Frequency

Control Agents

N/A

Study Protocol

Randomized