A Phase 2 interventional study of Cetuximab and EMD 1201081 in Squamous Cell Carcinoma of the Head and Neck Cancer, sponsored by EMD Serono. Completed at 35 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-30.
Sponsored by EMD Serono · Phase 2, Interventional, and Treatment
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).
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 107 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
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Drug: Cetuximab · Drug: EMD 1201081
Drug: Cetuximab
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.
Also known as: Erbitux®
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.
Also known as: IMO-2055
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.
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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
First participant enrolled: 17 Dec 2009; Last participant signed informed consent: 15 Aug 2011; Clinical data cut-off: 11 Jan 2012.
| Milestone | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy |
|---|---|---|
| Started | 54 | 53 |
| Completed | 8 | 16 |
| Not completed | 46 | 37 |
| Withdrew: Adverse event | 4 | 5 |
| Withdrew: Death | 4 | 6 |
| Withdrew: Withdrawal by subject | 2 | 3 |
| Withdrew: Progressive disease | 32 | 17 |
| Withdrew: Symptomatic deterioration | 2 | 5 |
| Withdrew: Other | 2 | 1 |
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.
| months | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy |
|---|---|---|
| Progression-free Survival (PFS) Time: Independent Read Assessments | 1.5 (1.3 to 2.6) | 1.9 (1.5 to 2.9) |
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.
| percentage of participants | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy |
|---|---|---|
| Percentage of Participants With Objective Response: Independent Read Assessments | 5.7 (1.2 to 15.7) | 5.7 (1.2 to 15.7) |
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.
| percentage of participants | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy |
|---|---|---|
| Percentage of Participants With Disease Control: Independent Read Assessments | 37.7 (24.8 to 52.1) | 43.4 (29.8 to 57.7) |
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.
| months | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy |
|---|---|---|
| Overall Survival (OS) Time | 6.3 (4.2 to 9.0) | — |
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.
| participants | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy |
|---|---|---|
| TEAEs | 52 | 53 |
| Serious TEAEs | 27 | 23 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cetuximab Plus EMD 1201081 | — | 27/54 (50%) | 51/54 (94.4%) |
| Cetuximab Monotherapy | — | 23/53 (43.4%) | 53/53 (100%) |
| Event | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy |
|---|---|---|
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 1/54 | 3/53 |
| DISEASE PROGRESSIONGeneral disorders | 3/54 | 1/53 |
| RESPIRATORY FAILURERespiratory, thoracic and mediastinal disorders | 3/54 | 1/53 |
| TRACHEOSTOMY MALFUNCTIONInjury, poisoning and procedural complications | 0/54 | 2/53 |
| MALNUTRITIONMetabolism and nutrition disorders | 0/54 | 2/53 |
| TUMOUR HAEMORRHAGENeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/54 | 2/53 |
| PNEUMOTHORAXRespiratory, thoracic and mediastinal disorders | 0/54 | 2/53 |
| DYSPHAGIAGastrointestinal disorders | 2/54 | 1/53 |
| DRUG HYPERSENSITIVITYImmune system disorders | 2/54 | 0/53 |
| BRONCHOPNEUMONIAInfections and infestations | 2/54 | 0/53 |
| Event | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy |
|---|---|---|
| RASHSkin and subcutaneous tissue disorders | 16/54 | 18/53 |
| DERMATITIS ACNEIFORMSkin and subcutaneous tissue disorders | 12/54 | 16/53 |
| FATIGUEGeneral disorders | 8/54 | 12/53 |
| INJECTION SITE REACTIONGeneral disorders | 11/54 | 0/53 |
| DIARRHOEAGastrointestinal disorders | 6/54 | 10/53 |
| HYPOMAGNESAEMIAMetabolism and nutrition disorders | 10/54 | 9/53 |
| ANAEMIABlood and lymphatic system disorders | 9/54 | 5/53 |
| STOMATITISGastrointestinal disorders | 9/54 | 6/53 |
| PYREXIAGeneral disorders | 9/54 | 3/53 |
| DECREASED APPETITEMetabolism and nutrition disorders | 9/54 | 3/53 |
Intent-to-treat (ITT) population included all the randomized participants who had received study treatment.
| Age, Continuous(years) | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy | Total |
|---|---|---|---|
| Mean | 56.8 ± 7.03 | 56.8 ± 10.03 | 56.8 ± 8.62 |
| Gender(Participants) | Cetuximab Plus EMD 1201081 | Cetuximab Monotherapy | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 45 | 45 | 90 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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