West Cancer Center

HEAD AND NECK: Metastatic; 2nd line; any PD-L1 status; "D4193C00002"

A phase III randomized, open-label, multi-center, global study of MEDI4736 monotherapy and MEDI4736 in combination with tremelimumab versus standard of care therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)

Title

AstraZeneca D4193C00002

Study Title

Site Link

NCT02369874

Malignancy

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

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line (after progression on platinum therapy)

Investigational Agent

MEDI4736 and Tremelimumab

Drug Class

PD-L1 inhibitor and CTLA-4 inhibitor

Moon Fenton, MD, PhD

Sponsor

AstraZeneca

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02369874

Key Eligibility Criteria Details

Histologically confirmed recurrent or metastatic SCCHN
Either progression after 1 line of chemo (must have contained platinum) or within 6 months of definitive multimodality therapy (containing platinum).
Tissue available for central PD-L1 testing
ECOG PS 0-1
At least one lesion that was not previously irradiated
No prior exposure to immune-mediated therapy
No history of CNS involvement
No history of primary immunodeficiency

Objective

Primary- OS, PFS: Secondary- ORR, DoR, DCR, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Squamous cell carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes