West Cancer Center

HEAD AND NECK: Metastatic; SCCHN; 2nd Line; PD-L1+; "D4193C00001"

A Phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)

Title

AstraZeneca D4193C00001

Study Title

A Phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)

Site Link

NCT02207530

Malignancy

Head and Neck, SCCHN, Laryngeal, Oral cavity, oropharynx, hypopharynx

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd

Investigational Agent

MED4736

Drug Class

anti-PD-L1 antibody

Moon Fenton, MD, PhD

Sponsor

AstraZeneca

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02207530

Key Eligibility Criteria Details

Recurrent or metastatic SCCHN
Confirmed PD-L1 positive by specified IHC assay (central)
Tumor progressionfollowing 1st line platinum therapy
Performance Status 0-1
At least one measurable lesion
No other concurrent chemo/anti-cancer tx
No autoimmune dz or immunodeficiency

Objective

Primary- ORR: Secondary- DoR, Disease Control Rate, QoL, PFS, OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

PD-L1 positiveSquamous cell

Dosing Frequency

MEDI4736 10mg/kg IV q2 weeks

Control Agents

N/A

Study Protocol

Randomized