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Head & NeckTemporarily On HoldPhase 1

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)

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Study snapshot

Title
Bristol-Myers Squibb CA223-001
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
Principal investigator
Moon Fenton, MD, PhD
Sponsor
Bristol-Myers Squibb
Intervention arm
Nivolumab + Lirilumab
Path
Squamous cell carcinoma
Control agents
N/A
Randomized
No
ClinicalTrials.gov ID
NCT01714739

Eligibility and objectives

Eligibility criteria link
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

Treatment details