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Squamous Cell Carcinoma of the Head and Neck CancerPhase 2NCT01040832

EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study testing Cetuximab and EMD 1201081 in people with Squamous Cell Carcinoma of the Head and Neck Cancer, run by EMD Serono at 35 sites in 8 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

The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is more efficient than cetuximab alone to control the cancer. EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cetuximab and EMD 1201081
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
35 sitesin 8 countries
Study dates
Dec 2009to Jan 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated written informed consent prior to any trial-specific procedure
  • Male or female subjects age greater than or equal to (>=) 18 years with R/M SCCHN
  • Histologically confirmed R/M SCCHN, documented in the medical record
  • History of progressing disease on a first-line cytotoxic chemotherapy regimen for R/M SCCHN, such as 5-fluorouracil (FU) plus cisplatin, or taxanes. (A history of chemotherapy or radiotherapy for localized disease was not considered a first-line regimen)
  • The subject is suited for systemic therapy in the opinion of the Investigator
  • At least one radiographically documented lesion measurable according to response evaluation criteria in solid tumors (RECIST) 1.0. All target lesions are to be measurable (that is, the lesion must be adequately measurable in at least one dimension; longest diameter to be recorded as >= 2 centimeter (cm) by conventional techniques or >= 1 centimeter (cm) by spiral computed tomography [CT] scan). Target lesions are to be selected from the required protocol imaging. If the sole site of measurable disease is in a prior radiation field, there has to be unequivocal evidence of progression at >= 8 weeks since the completion of radiation or a positive biopsy
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  • Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1
  • If female, either post-menopausal, surgically sterile, or having a negative urine or serum pregnancy test (beta-human chorionic gonadotropin [beta-HCG]) at screening and practicing medically accepted contraception. If male, practicing contraception if the risk of conception exists. For relevant subjects, the duration of contraception should be 1 week prior to the start of therapy through 4 weeks after receipt of trial therapy
  • Recovered from previous toxicities of prior cytotoxic regimen to common terminology criteria of adverse events (CTCAE) Grade 1 (with the exception of alopecia)
  • Hemoglobin >= 9 gram per deciliter (g/dL) without transfusion support; no transfusion within 7 days prior to screening)
  • Neutrophils >= 1.5 * 10^9 per liter
  • Platelets >= 100 * 10^9 per liter
  • Prothrombin time/partial thromboplastin time (PT/PTT) less than or equal to (=<) 1.5 times the upper limit of normal (ULN) for the site, unless there is therapeutic anti-coagulation
  • Serum creatinine =< 1.5 times the ULN for the site
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 times the ULN for the site
  • Be willing and able to comply with the protocol procedures for the duration of the trial

Who cannot join

  • History of prior exposure to cetuximab or panitumumab or any other approved or investigational anti-epidermal growth factor receptor (EGFR) agents
  • Undifferentiated nasopharyngeal carcinoma
  • Chemotherapy, radiotherapy or any investigational agents within 4 weeks prior to first dose of study drug
  • Major surgical or planned procedure within 30 days prior to first dose of trial medication (isolated biopsies are not considered major surgical procedures)
  • Active malignancy other than SCCHN, non-metastatic basal cell or squamous cell carcinoma of the skin, or second primary SCCHN
  • Impaired cardiac function (for example, left ventricular ejection fraction less than [<] 45 percent defined by echocardiograph or other study), history of uncontrolled serious arrhythmia, unstable angina pectoris, congestive heart failure (new york heart association [NYHA] Grade III and IV), myocardial infarction within the last 12 months prior to trial entry, or signs of pericardial effusion
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  • Hypertension uncontrolled by standard pharmacologic therapies
  • History of diagnosed interstitial lung disease
  • Subject requires systemic anti-coagulation (example, warfarin greater than [>] 10 milligram per day [mg/day])
  • Pregnancy or breastfeeding
  • Legal incapacity or limited legal capacity
  • Significant medical or psychiatric disease which makes the trial inappropriate in the Investigator's opinion
  • Any brain metastasis and/or leptomeningeal disease (known or suspected)
  • Significant pre-existing immune deficiency, such as infection of human immuno-deficiency virus (HIV) (documented or known)
  • Clinically significant ongoing infection
  • Known hypersensitivity to the trial treatments
  • Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer from such disease
  • Other significant disease that in the Investigator's opinion would exclude the subject from the trial

Trial locations and contacts

35 sites in 8 countries.

35 sites in 8 countries

United Kingdom9 sites

  • Velindre Cancer Centre

    Cardiff

  • Research Site

    Conventry

  • MHCW

    Coventry

  • St. James' University Hospital

    Leeds

  • Research Site

    London

  • The Christie NHS FT

    Manchester

  • Research Site

    Newcastle upon Tyne

  • Weston Park Hospital

    Sheffield

  • Southampton University Hospitals NHS Trust

    Southampton

Other trials in United Kingdom

Hungary7 sites

  • Research Site

    Győr

  • Research Site

    Kecskemét

  • Research Site

    Miskolc

  • Research Site

    Nyiregyahaza

  • Szegedi Tudomayegyetem Altalanos Orvostudomanyi Kar Onkoterapias Klinika

    Szeged

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok

  • Zala Megyei Kohaz Kulsokorhaz Onkologia Osztaly

    Zalaegerszeg

Other trials in Hungary

United States4 sites

  • University of Colorado Cancer Center

    Aurora, Colorado

  • MGH Massachusetts General Hospital

    Boston, Massachusetts

  • University of Kentucky, Markey Cancer Center

    Lexington, Kentucky

  • Montefiore Medical Center Oncology

    The Bronx, New York

Other trials in United States

Belgium4 sites

  • Research Site

    Brussels

  • UZ Gent

    Ghent

  • Research Site

    Wilrijk

  • Cliniques Universitaires Mont-Godinne

    Yvoir

Other trials in Belgium

Czechia4 sites

  • Research Site

    Brno

  • Research Site

    Kladno

  • Research Site

    Pardubice

  • Ustav radiacni onkologie Fakultni nemacnice Na Bulovce

    Prague

Other trials in Czechia

Poland3 sites

  • SPZOZ Centrum Onkologi Liemi Lubelskiej, II Odzial Radioterapiii z pododdzialem Chemioterpii

    Lublin

  • Zaklad Opleki Zdrowotnej MSWIA z Warminsko-Mazurskim Centrum Onkologil, Oddziat Chemioterapli

    Olsztyn

  • Centrum Onkologi - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Glowy i Szyi (NCI)

    Warsaw

Other trials in Poland

France2 sites

  • Research Site

    Montpellier

  • Research Site

    Villejuif

Other trials in France

Slovakia2 sites

  • Onkologicky ustav Sv. Alzbety

    Bratislava

  • Nemocnice s poliklinikou Zilina

    Žilina

Other trials in Slovakia

About this study

Official title: A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is more efficient than cetuximab alone to control the cancer.

EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9).

Read more

EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two studies have been conducted in healthy volunteers. In the other five studies, subjects with advanced solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal cancer have been treated with EMD 1201081. Two studies are still ongoing. Future clinical development of EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of the head and neck (SCCHN).

In this Phase 2 study, subjects with recurrent or metastatic squamous cell cancer of the head and neck (R/M SCCHN), will be treated with cetuximab plus EMD 1201081 or cetuximab alone. The study will be conducted as a multicenter study in several European Union (EU) member states and the Unites States.

EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in subjects by examining its effects on accepted clinical endpoints. Progression-free survival (PFS) will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to cetuximab alone in cetuximab-naïve subjects with R/M SCCHN who have progressed on a cytotoxic therapy.

Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as investigational medicinal product (IMP) in this study. Commercially available Cetuximab will be provided in the United States.

Being tested
Cetuximab, EMD 1201081
Keywords
Head and Neck Cancer, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer, Cetuximab, EMD 1201081
Medical subject headings
Head and Neck Neoplasms, Recurrence

What participants receive

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

  • CetuximabDrug

    Also called Erbitux®

    Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) will be administered in 3-week treatment cycle until disease progression. The total treatment period will be approximately 18 months.

  • EMD 1201081Drug

    Also called IMO-2055

    EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) will be administered in 3-week treatment cycle until disease progression. Subjects who will discontinue cetuximab due to toxicity in cetuximab monotherapy, could continue to receive EMD 1201081 monotherapy until disease progression. The total treatment period will be approximately 18 months.

Study groups in NCT01040832
Study groupRoleWhat they receive
Cetuximab plus EMD 1201081ExperimentalNot described
Receives: Drug: Cetuximab; Drug: EMD 1201081
Cetuximab monotherapyActive comparatorNot described
Receives: Drug: Cetuximab

What is being measured

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

  1. Progression-free Survival (PFS) Time: Independent Read Assessments

    The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event were censored on the date of last tumor assessment.

    Measured: Every 6 weeks until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)

Secondary outcomes (4)

  1. Percentage of Participants With Objective Response: Independent Read Assessments

    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as assessed by Independent Read. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.

    Measured: Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)

  2. Percentage of Participants With Disease Control: Independent Read Assessments

    Percentage of participants with disease control, defined as having achieved CR or PR or stable disease (SD) as the tumor response according to radiological assessments (based on RECIST Version 1.0 criteria), was reported. As per RECIST v1.0 for target lesions and assessed by MRI: CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

    Measured: Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)

  3. Overall Survival (OS) Time

    The overall survival (OS) time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.

    Measured: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)

  4. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

    An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.

    Measured: Time from first dose up to Day 42 to 49 after last dose of trial treatment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)

Timeline

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

  1. First posted30 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionJan 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01040832
Sponsor's protocol ID
EMR 200068-006
Status last verified
Jul 2014
First submitted
29 Dec 2009
Last updated
30 Jan 2017
Data monitoring committee
Yes

Publications

  • Ruzsa A, Sen M, Evans M, Lee LW, Hideghety K, Rottey S, Klimak P, Holeckova P, Fayette J, Csoszi T, Erfan J, Forssmann U, Goddemeier T, Bexon A, Nutting C; NA EMD 1201081 Study Group. Phase 2, open-label, 1:1 randomized controlled trial exploring the efficacy of EMD 1201081 in combination with cetuximab in second-line cetuximab-naive patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Invest New Drugs. 2014 Dec;32(6):1278-84. doi: 10.1007/s10637-014-0117-2. Epub 2014 Jun 4.

    PubMed 24894651

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab and EMD 1201081 in people with Squamous Cell Carcinoma of the Head and Neck Cancer, run by EMD Serono at 35 sites in 8 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 16 inclusion and 18 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United Kingdom, Hungary, United States, Belgium, Czechia and 3 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 29 Jul 2014). 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?

Progression-free Survival (PFS) Time: Independent Read Assessments (time frame: Every 6 weeks until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)). 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 NCT01040832, which also lists 1 linked publication.

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 30 Jan 2017.

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