NCT02207530CompletedPhase 2
A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
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 have progressed during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 130 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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 Criteria
- •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
Arms & Interventions
MEDI4736
Experimental
MEDI4736 monotherapy
Intervention: MEDI4736 (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: 12 months
Objective response rate (per RECIST 1.1 as assessed by blinded independent central review \[BICR\]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1. criteria are: Complete response \[CR\] = disappearance of all target lesions since baseline; and partial response \[PR\] = at least a 30% decrease in the sum of the diameters of target lesions.
Secondary Outcomes
- Duration of Response(12 months)
- Time to Onset of Response From First Dose(12 months)
- Best Objective Response(12 months)
- Progression-free Survival(12 months)
- Duration of Response- Participants Remaining in Response(12 months)
- Quality of Life(12 months)
- Disease Control at 6 Months(6 months)
- Overall Survival (OS)(12 months)
Investigators
Study Sites (1)
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