Trial Search Results

Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer

The purpose of this study is to investigate whether treatment with the experimental anti-cancer drugs (either MEDI4736 alone or MEDI4736 + tremelimumab) will have a positive influence on cancer and is well tolerated compared to standard, approved treatments. MEDI4736 and tremelimumab are antibodies (proteins produced by the defense system of the body [immune system]) that have been made in the laboratory. Both MEDI4736 alone or in combination with tremelimumab may boost the ability of the immune system to detect and fight cancer. Tremelimumab works in a different but complementary way with MEDI4736.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Stanford Investigator(s):

Intervention(s):

  • Drug: MEDI4736
  • Drug: MEDI4736 + Tremelimumab
  • Drug: Standard of Care

Phase:

Phase 3

Eligibility


Inclusion Criteria: - Age ≥18 years; - Written informed consent obtained from the
patient/legal representative; - Histologically or cytologically confirmed recurrent or
metastatic SCCHN; - Tumor progression or recurrence during or after only one palliative
systemic treatment regimen for recurrent or metastatic disease that must have contained a
platinum agent OR progression within 6 months of the last dose of platinum given as part of
multimodality therapy with curative intent; - Confirmed PD-L1-positive or -negative SCCHN
by the Ventana PD-L1 SP263 IHC assay; - WHO/Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1; At least 1 measurable lesion, - Not previously irradiated; -
No prior exposure to immune-mediated therapy; - Adequate organ and marrow function;
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female
pre-menopausal patients. Exclusion Criteria: - Histologically or cytologically confirmed
squamous cell carcinoma of any other primary anatomic location in the head and neck; -
Received more than 1 palliative systemic 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; - Patients with a history of
brain metastases, spinal cord compression, or leptomeningeal carcinomatosis; - Mean QT
interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs)
using Fridericia's Correction; - History of active primary immunodeficiency; - Active
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; -
Known allergy or hypersensitivity to Investigational Product

Ages Eligible for Study

18 Years - 96 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting