Phase II study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck

Study identifier:D4193C00003

ClinicalTrials.gov identifier:NCT02319044

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination with Tremelimumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Medical condition

Recurrent/metastatic squamous cell carcinoma of head & neck

Phase

Phase 2

Healthy volunteers

No

Study drug

MEDI4736, Tremelimumab, MEDI4736 + Tremelimumab

Sex

All

Actual Enrollment

267

Study type

Interventional

Age

18 Years - 96 Years

Date

Study Start Date: 15 Apr 2015
Primary Completion Date: 26 Sept 2016
Study Completion Date: 06 Jul 2020

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PRA Health Sciences

Inclusion and exclusion criteria