Clinical trial NCT02207530: Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
Keywords: Head and neck cancer; SCCHN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2014-08-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.
* 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 12 months
Secondary outcomes:
measure: Best Objective Response
timeFrame: 12 months
measure: Duration of Response- Participants Remaining in Response
timeFrame: 12 months
measure: Duration of Response
timeFrame: 12 months
measure: Time to Onset of Response From First Dose
timeFrame: 12 months
measure: Disease Control at 6 Months
timeFrame: 6 months
measure: Progression-free Survival
timeFrame: 12 months
measure: Overall Survival (OS)
timeFrame: 12 months
measure: Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Yuma
country: United States
facility: Research Site
state: Arizona
city: Duarte
country: United States
facility: Research Site
state: California
city: Fullerton
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
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state: Michigan
city: Southfield
country: United States
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state: Michigan
city: Minneapolis
country: United States
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state: Minnesota
city: Rochester
country: United States
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state: Minnesota
city: Saint Louis
country: United States
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state: Missouri
city: Lebanon
country: United States
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state: New Hampshire
city: Buffalo
country: United States
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state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Stony Brook
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Germantown
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Fairfax
country: United States
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state: Virginia
city: Morgantown
country: United States
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state: West Virginia
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Brussels
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Montigny-le-Tilleul
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: London
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Zlin
country: Czechia
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Lille cedex
country: France
facility: Research Site
city: Lorient cedex
country: France
facility: Research Site
city: Lyon Cedex 08
country: France
facility: Research Site
city: Montpellier Cedex 05
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Plerin SUR MER
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: St Grégoire
country: France
facility: Research Site
city: Strasbourg Cedex
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
city: Batumi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Petach-Tikva
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
city: Sabah
country: Malaysia
facility: Research Site
city: Barakaldo
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Marbella (Málaga)
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Wirral
country: United Kingdom
facility: Research Site
Study officials:
affiliation: International Coordinating Investigator
name: Dan Paul Zandberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Scientist AstraZeneca Magdalena.Wrona@astrazeneca.com
name: Magdalena Wrona
role: STUDY_DIRECTOR
References: