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

• Status: Completed
• Trial end date: 2020-07-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: PRA Health Sciences
• Treatments: Antibodies, Monoclonal; Durvalumab; Tremelimumab

Criteria

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