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D5660C00004


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
Therapeutic Area Head and Neck Cancer
Principal Investigator Robert Martell, MD
Min Age 18 Years
Gender Both
Contact Madeleine Arthur
617-636-7651
More Information https://clinicaltrials.gov/ct2/show/NCT02499328

Overview

This study is to evaluate the overall response rate of two experimental drugs, AZD9150 and AZD5069, both as single medicine treatments and in combination with another study drug,MEDI4736, in the second-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Study Details

Inclusion Criteria

  • Must have undergone no more than 3 cytoreductive therapies (therapies to shrink cancer)
  • Must have adequate organ function
  • Must have measurable disease

Exclusion Criteria

  • Must not have had a second malignancy in the past 3 years
  • Must not have had any previous cancer-related treatments with 4 weeks of study start
  • Must not have had an organ transplant that requires use of immunosuppressive treatment

Study Requirements

Subjects will have to provide approximately 1-2 tablespoon of blood for research 3 times during cycle 1, 2 times during cycle 2 and once a cycle thereafter. Subjects will continue to receive study treatment until they experience unacceptable side effects or no longer receive any benefit from treatment. Scans will be done before study entry, after cycle 2, and every even cycle thereafter. The amount of time that study treatment will take varies on what arm subjects are randomized to. The study doctor will discuss this with subjects once randomization occurs, however infusions can take 1-2 hours to complete.