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

Completed · Phase 2

Conditions studied: Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck

In brief

The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.

Key facts

Study ID: NCT02319044
Run by: AstraZeneca
People needed: 267
Starts: 2015-04-15
Expected to finish: 2020-07-06
Last updated by the study team: 2020-09-29

Who can join

Age: 18 and older, up to 96. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years;
Written informed consent obtained from the patient/legal representative;
Histologically confirmed recurrent or metastatic SCCHN; tumor progression or recurrence during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent; Patients who have only received chemo-radiation with curative intent for treatment of their locally advanced disease or recurrent disease are not eligible. Patients who received concurrent chemo-radiation as part of treatment of their recurrent disease are also not eligible.
Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
Confirmed PD-L1-negative SCCHN by Ventana SP263;
WHO/ECOG performance status of 0 or 1;
At least 1 measurable lesion at baseline;
No prior exposure to immune-mediated therapy;
Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test.

You may not qualify if…

Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck;
Received more than 1 regimen for recurrent or metastatic disease
Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment;
Receipt of any investigational anticancer therapy within 28 days or 5 half-lives;
Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment;
Major surgical procedure within 28 days prior to the first dose of Investigational Product;
Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion;
Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product;
History of allogeneic organ transplantation;
Active or prior documented autoimmune or inflammatory disorders;
Uncontrolled intercurrent illness;
another primary malignancy
Patients with history of brain metastases, spinal cord compression, or a history of leptomeningeal carcinomatosis;
History of active primary immunodeficiency;
Known history of previous tuberculosis;
Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV);
Receipt of live, attenuated vaccine within 30 days prior to the first dose of Investigational Product;
Pregnant or breast-feeding female patients;
Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
Known allergy or hypersensitivity to Investigational Product.
Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results

Where it is running

Research Site — Yuma, Arizona, United States
Research Site — Little Rock, Arkansas, United States
Research Site — Downey, California, United States
Research Site — Duarte, California, United States
Research Site — La Jolla, California, United States
Research Site — Long Beach, California, United States
Research Site — Los Angeles, California, United States
Research Site — Los Angeles, California, United States
Research Site — San Francisco, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Tampa, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Augusta, Georgia, United States
Research Site — Macon, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Evanston, Illinois, United States
Research Site — Lexington, Kentucky, United States
Research Site — Baltimore, Maryland, United States
Research Site — Baltimore, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Detroit, Michigan, United States
Research Site — Southfield, Michigan, United States
Research Site — Rochester, Minnesota, United States
Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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