A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
PhasePhase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion 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.
- 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
Please contact Poornima Murali to learn more about where you can participate in this trial. Please use the contact form on the right side.