Study to assess MEDI4736 with either AZD9150 or AZD5069 in advanced solid tumors & relapsed metastatic Squamous cell carcinoma of head & neck - None

Study identifier:D5660C00004

ClinicalTrials.gov identifier:NCT02499328

EudraCT identifier:2015-002525-19

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

Medical condition

Advanced solid tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD9150, MEDI4736, AZD5069, tremelimumab (treme)

Sex

All

Actual Enrollment

340

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 06 Aug 2015
Primary Completion Date: 28 Feb 2020
Estimated Study Completion Date: 16 Mar 2025

Study design

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

Verification:

Verified 01 Dec 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

MedImmune Inc.

Inclusion and exclusion criteria