Status:
COMPLETED
Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief Summary
Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR
Detailed Description
This is a phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in patients with PD-L1 positive recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), who hav...
Eligibility Criteria
Inclusion
- 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.
- Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
- Confirmed PD-L1-positive SCCHN by Ventana SP263 assay
- 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
- Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck
- Received more than 1 systematic palliative regimen for recurrent or metastatic disease
- Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment
- Prior randomization or treatment in a previous MEDI4736 and/or tremelimumab clinical study regardless of treatment arm assignment or 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 MEDI4736
- 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 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 MEDI4736
- 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
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results
Key Trial Info
Start Date :
October 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT02207530
Start Date
October 23 2014
End Date
July 6 2020
Last Update
September 29 2020
Active Locations (108)
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1
Research Site
Birmingham, Alabama, United States, 35294-3300
2
Research Site
Yuma, Arizona, United States, 85364
3
Research Site
Duarte, California, United States, 91010
4
Research Site
Fullerton, California, United States, 92835