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Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and NeckPhase 2NCT02207530

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

A Phase 2 study testing MEDI4736 in people with Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck, run by AstraZeneca at 108 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR Read more about this study

Who is it for?
Ages 18 to 130 years
What is being tested?
MEDI4736
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
108 sitesin 14 countries
Study dates
23 Oct 2014to 6 Jul 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

108 sites in 14 countries.

108 sites in 14 countries

United States38 sites

  • Research Site

    Ann Arbor, Michigan, 48109-5000

  • Research Site

    Augusta, Georgia, 30912

  • Research Site

    Austin, Texas, 78701

  • Research Site

    Baltimore, Maryland, 21201

  • Research Site

    Baltimore, Maryland, 21204

  • Research Site

    Birmingham, Alabama, 35294-3300

  • Research Site

    Boston, Massachusetts, 02215

  • Research Site

    Buffalo, New York, 14215

  • Research Site

    Dallas, Texas, 75230

  • Research Site

    Denver, Colorado, 80045

  • Research Site

    Duarte, California, 91010

  • Research Site

    Durham, North Carolina, 27710

  • Research Site

    Evanston, Illinois, 60201

  • Research Site

    Fairfax, Virginia, 22031

  • Research Site

    Fullerton, California, 92835

  • Research Site

    Germantown, Tennessee, 38138

  • Research Site

    Jacksonville, Florida, 32207

  • Research Site

    Lebanon, New Hampshire, 3756

  • Research Site

    Lexington, Kentucky, 40536-0001

  • Research Site

    Long Beach, California, 90813

  • Research Site

    Los Angeles, California, 90025

  • Research Site

    Los Angeles, California, 90089

  • Research Site

    Los Angeles, California, 90095

  • Research Site

    Macon, Georgia, 31201

  • Research Site

    Milwaukee, Wisconsin, 53226

  • Research Site

    Minneapolis, Minnesota, 55407

  • Research Site

    Morgantown, West Virginia, 26506

  • Research Site

    Nashville, Tennessee, 37332

  • Research Site

    New York, New York, 10037

  • Research Site

    Portland, Oregon, 97213

  • Research Site

    Rochester, Minnesota, 55905-0001

  • Research Site

    San Francisco, California, 94115

  • Research Site

    Southfield, Michigan, 48075

  • Research Site

    St Louis, Missouri, 63110

  • Research Site

    Stony Brook, New York, 11795

  • Research Site

    Whittier, California, 90602

  • Research Site

    Winston-Salem, North Carolina, 27157-1023

  • Research Site

    Yuma, Arizona, 85364

Other trials in United States

France17 sites

  • Research Site

    Angers, 49933

  • Research Site

    Bordeaux, 33000

  • Research Site

    Brest, 29229

  • Research Site

    Clermont-Ferrand, 63011

  • Research Site

    Dijon, 21079

  • Research Site

    Le Mans, 72000

  • Research Site

    Lille, 59020

  • Research Site

    Lorient, 56322

  • Research Site

    Lyon, 69373

  • Research Site

    Montpellier, 34298

  • Research Site

    Nice, 06189

  • Research Site

    Plerin SUR MER, 22190

  • Research Site

    Rouen, 76021

  • Research Site

    Saint-Grégoire, 35768

  • Research Site

    Strasbourg, 67085

  • Research Site

    Toulouse, 31059

  • Research Site

    Villejuif, 94805

Other trials in France

Spain14 sites

  • Research Site

    Barakaldo, 48903

  • Research Site

    Barcelona, 08025

  • Research Site

    Barcelona, 08035

  • Research Site

    Barcelona, 08036

  • Research Site

    L'Hospitalet de Llobregat, 08907

  • Research Site

    Madrid, 28041

  • Research Site

    Madrid, 28046

  • Research Site

    Madrid, 28050

  • Research Site

    Málaga, 29010

  • Research Site

    Marbella (Málaga), 29600

  • Research Site

    Pamplona, 31008

  • Research Site

    Valencia, 46014

  • Research Site

    Valencia, 46026

  • Research Site

    Zaragoza, 50009

Other trials in Spain

Belgium5 sites

  • Research Site

    Brussels, 1090

  • Research Site

    Kortrijk, 8500

  • Research Site

    Leuven, 3000

  • Research Site

    Montigny-le-Tilleul, 6110

  • Research Site

    Namur, 5000

Other trials in Belgium

Canada5 sites

  • Research Site

    Calgary, Alberta, T2N 2T9

  • Research Site

    London, Ontario, N6A 4L6

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    Ottawa, Ontario, K1H 8L6

  • Research Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany5 sites

  • Research Site

    Berlin, 12200

  • Research Site

    Halle, 06120

  • Research Site

    Heidelberg, 69120

  • Research Site

    Leipzig, 04103

  • Research Site

    München, 81377

Other trials in Germany

United Kingdom5 sites

  • Research Site

    Birmingham, B15 2TH

  • Research Site

    Glasgow, G12 0YN

  • Research Site

    London, E1 1BB

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Metropolitan Borough of Wirral, CH63 4JY

Other trials in United Kingdom

Georgia4 sites

  • Research Site

    Batumi, 6010

  • Research Site

    Tbilisi, 0144

  • Research Site

    Tbilisi, 0177

  • Research Site

    Tbilisi, 0179

Other trials in Georgia

South Korea4 sites

  • Research Site

    Daegu, 42601

  • Research Site

    Goyang-si, 10408

  • Research Site

    Seoul, 03080

  • Research Site

    Suwon, 16247

Other trials in South Korea

Hungary3 sites

  • Research Site

    Budapest, 1122

  • Research Site

    Budapest, 1162

  • Research Site

    Gyula, 5700

Other trials in Hungary

Israel3 sites

  • Research Site

    Haifa, 31096

  • Research Site

    Petah Tikva, 4941492

  • Research Site

    Tel HaShomer, 52621

Other trials in Israel

Malaysia3 sites

  • Research Site

    Kuala Lumpur, 59100

  • Research Site

    Kuching, 93586

  • Research Site

    Sabak Bernam, 88996

Other trials in Malaysia

Czechia1 site

  • Research Site

    Zlín, 762 75

Other trials in Czechia

Taiwan1 site

  • Research Site

    Taipei, 10449

Other trials in Taiwan

About this study

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)

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

Read the 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.

Being tested
MEDI4736
Keywords
Head and neck cancer; SCCHN
Medical subject headings
Recurrence, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI4736Drug

    MEDI4736 monotherapy

Study groups in NCT02207530
Study groupRoleWhat they receive
MEDI4736ExperimentalMEDI4736 monotherapy
Receives: Drug: MEDI4736

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (8)

  1. Best Objective Response

    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.

    Measured: 12 months

  2. Duration of Response- Participants Remaining in Response

    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.

    Measured: 12 months

  3. Duration of Response

    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.

    Measured: 12 months

  4. Time to Onset of Response From First Dose

    Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1

    Measured: 12 months

  5. Disease Control at 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.

    Measured: 6 months

  6. Progression-free Survival

    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.

    Measured: 12 months

  7. Overall Survival (OS)

    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.

    Measured: 12 months

  8. Quality of Life

    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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2014 (estimated)
  2. Study start23 Oct 2014
  3. Primary completion26 Sep 2016
  4. Study completion6 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02207530
Sponsor's protocol ID
D4193C00001
Status last verified
Sep 2020
First submitted
1 Aug 2014
Last updated
29 Sep 2020
Data monitoring committee
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI4736 in people with Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck, run by AstraZeneca at 108 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, France, Spain, Belgium, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02207530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.

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