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Summary

for people ages 18–99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

Official Title

A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination With Tremelimumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Keywords

Squamous Cell Carcinoma of the Head and Neck Antibodies, Monoclonal Tremelimumab

Eligibility

You can join if…

Open to people ages 18–99

  1. Male and female subjects
  2. 18 years and older
  3. Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
  4. Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
  5. Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.

You CAN'T join if...

  1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
  2. Concurrent or prior use of immunosuppressive medication within 14 days
  3. Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.

Locations

  • Research Site
    San Francisco, California, United States
  • Research Site
    Los Angeles, California, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
ID
NCT02262741
Phase
Phase 1
Lead Scientist
Alain Algazi
Study Type
Interventional
Last Updated
May 1, 2017