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


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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