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

September 11, 2020 updated by: AstraZeneca

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Research Site
      • Kortrijk, Belgium, 8500
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Montigny-le-Tilleul, Belgium, 6110
        • Research Site
      • Namur, Belgium, 5000
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
  • Czechia
      • Zlin, Czechia, 762 75
        • Research Site
  • France
      • Angers, France, 49933
        • Research Site
      • Bordeaux, France, 33000
        • Research Site
      • Brest, France, 29229
        • Research Site
      • Clermont Ferrand, France, 63011
        • Research Site
      • Dijon, France, 21079
        • Research Site
      • Le Mans, France, 72000
        • Research Site
      • Lille cedex, France, 59020
        • Research Site
      • Lorient cedex, France, 56322
        • Research Site
      • Lyon Cedex 08, France, 69373
        • Research Site
      • Montpellier Cedex 05, France, 34298
        • Research Site
      • Nice, France, 06189
        • Research Site
      • Plerin SUR MER, France, 22190
        • Research Site
      • Rouen, France, 76021
        • Research Site
      • St Grégoire, France, 35768
        • Research Site
      • Strasbourg Cedex, France, 67085
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
      • Villejuif Cedex, France, 94805
        • Research Site
  • Georgia
      • Batumi, Georgia, 6010
        • Research Site
      • Tbilisi, Georgia, 0144
        • Research Site
      • Tbilisi, Georgia, 0179
        • Research Site
      • Tbilisi, Georgia, 0177
        • Research Site
  • Germany
      • Berlin, Germany, 12200
        • Research Site
      • Halle, Germany, 06120
        • Research Site
      • Heidelberg, Germany, 69120
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • München, Germany, 81377
        • Research Site
  • Hungary
      • Budapest, Hungary, 1122
        • Research Site
      • Budapest, Hungary, 1162
        • Research Site
      • Gyula, Hungary, 5700
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Petach-Tikva, Israel, 4941492
        • Research Site
      • Tel Hashomer, Israel, 52621
        • Research Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 42601
        • Research Site
      • Goyang-si, Korea, Republic of, 10408
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Suwon, Korea, Republic of, 16247
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Kuching, Malaysia, 93586
        • Research Site
      • Sabah, Malaysia, 88996
        • Research Site
  • Spain
      • Barakaldo, Spain, 48903
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Barcelona, Spain, 08025
        • Research Site
      • L'Hospitalet de Llobregat, Spain, 08907
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28050
        • Research Site
      • Malaga, Spain, 29010
        • Research Site
      • Marbella (Málaga), Spain, 29600
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
      • Valencia, Spain, 46014
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Taiwan
      • Taipei, Taiwan, 10449
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Research Site
      • Glasgow, United Kingdom, G12 0YN
        • Research Site
      • London, United Kingdom, E1 1BB
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Wirral, United Kingdom, CH63 4JY
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Research Site
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • Fullerton, California, United States, 92835
        • Research Site
      • Long Beach, California, United States, 90813
        • Research Site
      • Los Angeles, California, United States, 90025
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Los Angeles, California, United States, 90089
        • Research Site
      • San Francisco, California, United States, 94115
        • Research Site
      • Whittier, California, United States, 90602
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80045
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Research Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Research Site
      • Macon, Georgia, United States, 31201
        • Research Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0001
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Research Site
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5000
        • Research Site
      • Southfield, Michigan, United States, 48075
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
      • Rochester, Minnesota, United States, 55905-0001
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 3756
        • Research Site
    • New York
      • Buffalo, New York, United States, 14215
        • Research Site
      • New York, New York, United States, 10037
        • Research Site
      • Stony Brook, New York, United States, 11795
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Winston-Salem, North Carolina, United States, 27157-1023
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Research Site
      • Nashville, Tennessee, United States, 37332
        • Research Site
    • Texas
      • Austin, Texas, United States, 78701
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEDI4736
MEDI4736 monotherapy
Drug: MEDI4736
MEDI4736 monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Objective Response
Time Frame: 12 months

Best objective response based on BICR assessments according to RECIST v1.1. Response required confirmation after 4 weeks.

Unconfirmed complete (CR) or partial response (PR) refers to CR or PR achieved but either no confirmation assessment was performed or a confirmation assessment was performed but response was not confirmed.
12 months
Duration of Response- Participants Remaining in Response
Time Frame: 12 months

Participants remaining in response - based on BICR assessments according to RECIST v1.1.

An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off.
12 months
Duration of Response
Time Frame: 12 months

Duration of objective response in patients with objective response based on BICR assessments according to RECIST v1.1.

Duration of response was the time from the first documentation of complete or partial response until the date of progression (which was subsequently confirmed), death, or the last evaluable RECIST assessment for patients that did not progress.

An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off.
12 months
Time to Onset of Response From First Dose
Time Frame: 12 months
Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1
12 months
Disease Control at 6 Months
Time Frame: 6 months

Disease control (DCR) at 6 months based on BICR assessments according to RECIST v1.1.

DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD):

  • Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following the start of study treatment.
  • Method 2: Patients who had a best objective response of CR or PR within 24 weeks or had demonstrated SD for a minimum interval of 16 weeks following the start of study treatment.
6 months
Progression-free Survival
Time Frame: 12 months

Progression status based on BICR assessments according to RECIST v1.1 at time of PFS analysis.

Progression was defined as the time from the date of first dose until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression.
12 months
Overall Survival (OS)
Time Frame: 12 months
Survival status at time of overall survival analysis. 'Still in survival follow-up' includes patients known to be alive at data cut-off. 'Terminated prior to death' includes patients with unknown survival status, or who were lost to follow-up.
12 months
Quality of Life
Time Frame: 12 months

Improvement in quality of life was assessed using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires:

  • The impact of treatment on Health-Related Quality of Life, functioning, and symptoms was evaluated using the EORTC QLQ-C30 v3.
  • Head and neck cancer-specific symptoms were evaluated using the EORTC QLQ-H&N35.

Function or global health status/quality of life improvement was defined as patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (an increase from baseline score ≥10). Symptom improvement was defined as 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10).

Scale improvement was defined as patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

PRA Health Sciences

Investigators

  • Study Director: Magdalena Wrona, Medical Scientist AstraZeneca Magdalena.Wrona@astrazeneca.com
  • Principal Investigator: Dan Paul Zandberg, MD, International Coordinating Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2014

Primary Completion (Actual)

September 26, 2016

Study Completion (Actual)

July 6, 2020

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4193C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing 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

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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