Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT02207530 | Completed Phase 2 Results

• 1 other identifier: D4193C00001
• Study Type: interventional
• Target: 112
• Locations: 14 countries
• Sites: 108

Brief Summary

Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

Conditions

Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck

Keywords

Head and neck cancer; SCCHN

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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.

  12 months

Secondary Outcomes (8)

• Best Objective Response

  12 months

• Duration of Response- Participants Remaining in Response

  12 months

• Duration of Response

  12 months

• Time to Onset of Response From First Dose

  12 months

• Disease Control at 6 Months

  6 months

Study Arms (1)

MEDI4736

EXPERIMENTAL

MEDI4736 monotherapy

Drug: MEDI4736

Interventions

MEDI4736 DRUG

MEDI4736 monotherapy

MEDI4736

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• AstraZeneca: lead
• PRA Health Sciences: collaborator

Study Sites (108)

Research Site

Birmingham, Alabama, 35294-3300, United States

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Yuma, Arizona, 85364, United States

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Duarte, California, 91010, United States

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Fullerton, California, 92835, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90089, United States

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Los Angeles, California, 90095, United States

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San Francisco, California, 94115, United States

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Whittier, California, 90602, United States

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Denver, Colorado, 80045, United States

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Jacksonville, Florida, 32207, United States

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Augusta, Georgia, 30912, United States

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Macon, Georgia, 31201, United States

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Evanston, Illinois, 60201, United States

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Lexington, Kentucky, 40536-0001, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21204, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109-5000, United States

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Southfield, Michigan, 48075, United States

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Minneapolis, Minnesota, 55407, United States

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Rochester, Minnesota, 55905-0001, United States

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St Louis, Missouri, 63110, United States

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Lebanon, New Hampshire, 3756, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10037, United States

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Stony Brook, New York, 11795, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157-1023, United States

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Portland, Oregon, 97213, United States

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Germantown, Tennessee, 38138, United States

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Nashville, Tennessee, 37332, United States

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Austin, Texas, 78701, United States

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Dallas, Texas, 75230, United States

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Fairfax, Virginia, 22031, United States

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Morgantown, West Virginia, 26506, United States

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Milwaukee, Wisconsin, 53226, United States

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Brussels, 1090, Belgium

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Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Montigny-le-Tilleul, 6110, Belgium

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Namur, 5000, Belgium

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Calgary, Alberta, T2N 2T9, Canada

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London, Ontario, N6A 4L6, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H4A 3J1, Canada

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Zlín, 762 75, Czechia

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Angers, 49933, France

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Bordeaux, 33000, France

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Brest, 29229, France

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Clermont-Ferrand, 63011, France

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Dijon, 21079, France

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Le Mans, 72000, France

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Lille, 59020, France

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Lorient, 56322, France

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Lyon, 69373, France

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Montpellier, 34298, France

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Nice, 06189, France

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Plerin SUR MER, 22190, France

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Rouen, 76021, France

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Saint-Grégoire, 35768, France

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Strasbourg, 67085, France

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Toulouse, 31059, France

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Villejuif, 94805, France

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Batumi, 6010, Georgia

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Tbilisi, 0144, Georgia

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Tbilisi, 0177, Georgia

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Tbilisi, 0179, Georgia

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Berlin, 12200, Germany

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Halle, 06120, Germany

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Heidelberg, 69120, Germany

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Leipzig, 04103, Germany

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München, 81377, Germany

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Budapest, 1122, Hungary

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Budapest, 1162, Hungary

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Gyula, 5700, Hungary

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Haifa, 31096, Israel

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Petah Tikva, 4941492, Israel

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Tel Litwinsky, 52621, Israel

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Kuala Lumpur, 59100, Malaysia

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Kuching, 93586, Malaysia

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Sabak Bernam, 88996, Malaysia

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Daegu, 42601, South Korea

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Goyang-si, 10408, South Korea

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Seoul, 03080, South Korea

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Suwon, 16247, South Korea

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Barakaldo, 48903, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Madrid, 28050, Spain

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Marbella (Málaga), 29600, Spain

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Málaga, 29010, Spain

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Pamplona, 31008, Spain

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Valencia, 46014, Spain

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Valencia, 46026, Spain

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Zaragoza, 50009, Spain

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Taipei, 10449, Taiwan

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Birmingham, B15 2TH, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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London, E1 1BB, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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MeSH Terms

Conditions

Recurrence; Head and Neck Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Jean Fan, MD, Global Clinical Lead
• Organization: AstraZeneca LP

jean.fan@astrazeneca.com

1-301-398-5080

Study Officials

• Dan Paul Zandberg, MD

  International Coordinating Investigator

  PRINCIPAL INVESTIGATOR

• Magdalena Wrona

  Medical Scientist AstraZeneca Magdalena.Wrona@astrazeneca.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 4, 2014
• Study Start: October 23, 2014
• Primary Completion: September 26, 2016
• Study Completion: July 6, 2020
• Last Updated: September 29, 2020
• Results First Posted: June 18, 2018

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

BE (5); CA (5); ES (14); TW (1); GB (5); DE (5); FR (17); CZ (1); HU (3); IL (3); MY (3); KR (4); US (38); GE (4)