Squamous Cell Carcinoma of the Head and NeckPhase 1NCT01360827
EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study testing EMD 1201081 + 5-FU + Cisplatin + Cetuximab in people with Squamous Cell Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
Trial summary
The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- EMD 1201081 + 5-FU + Cisplatin + Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2010to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
- Recurrent and/or metastatic SCCHN, not suitable for local therapy.
- At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).
- Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.
Who cannot join
- Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.
- Nasopharyngeal carcinoma.
- Medical history of diagnosed interstitial lung disease.
- Known hypersensitivity against any of the components of the trial treatment.
- Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).
- Relevant cardiovascular co-morbidities.
- Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent.
- Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Research Unit and Pharmacology Lab EA 3035 Institut Claudius Regaud
Toulouse
About this study
Official title: Phase Ib Trial of Multiple-ascending Doses of EMD 1201081 in Combination With 5-FU/Cisplatin and Cetuximab in First-line Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck
The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.
- Being tested
- EMD 1201081 + 5-FU + Cisplatin + Cetuximab
- Keywords
- Safety, tolerability, maximum tolerated dose of EMD 1201081, TLR9 agonists, squamous cell carcinoma of the head and neck, First line subjects, recurrent/metastatic
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMD 1201081 + 5-FU + Cisplatin + CetuximabDrug
3-6 subjects per cohort will receive EMD 1201081 as a weekly subcutaneous injection on Days 1, 8, and 15 in 3-week cycles at dose levels of 0.16, 0.32, and 0.48mg/kg, respectively until progression of disease, unacceptable toxicity, or subject refusal to continue in the trial. EMD 1201081 will always be given after (within 1 hour) completion of the cetuximab infusion and before the start of chemotherapy.
EMD 1201081 + 5-FU + Cisplatin + CetuximabDrug
Part 2 seeks to enroll 12 subjects at the MTD of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab; furthermore, an additional 3 to 6 subjects for a total of 9 subjects will be accrued at the 0.16 mg/kg low dose level in Part 2a once the Part 1 0.16 mg/kg dose cohort has been accrued and it is deemed safe to proceed to the 0.32 mg/kg dose cohort. EMD 1201081 will always be given after (within 1 hour) completion of the cetuximab infusion and before the start of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Part 1) | Experimental | Not described Receives: Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab |
| Arm 2 (Expansion cohorts -Part 2 and Part 2a) | Experimental | Not described Receives: Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated-dose (MTD) at 0.16 mg/kg cohort size testing
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Measured: 3 weeks
Maximum-tolerated-dose (MTD) at 0.32 mg/kg cohort size testing
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Measured: 3 weeks
Maximum-tolerated-dose (MTD) at 0.48 mg/kg cohort size testing
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Measured: 3 weeks
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline up to 49 days after last study drug administration
Secondary outcomes (2)
Number of subjects with best overall response
Measured: 8 months
Pharmacokinetic parameters: Cmax, Tmax and AUC (0-t)
Measured: Days 1, 8 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startAug 2010
- Primary completionApr 2011
Why it stopped: Study terminated due to potential safety concerns in combination with platinum-based therapies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Jean-Pierre Delord, Principal investigator, Clinical Research Unit and Pharmacology Lab EA 3035, Institut Claudius Regaud, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360827
- Sponsor's protocol ID
- EMR 200068-007
- Status last verified
- Jun 2014
- First submitted
- 24 May 2011
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Trial of Multiple-ascending Doses of EMD 1201081 in Combination With 5-FU/Cisplatin and Cetuximab in First-line Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT01360827
- Acronym / sponsor ID
- EMR 200068-007
- Keywords
- Safety, tolerability, maximum tolerated dose of EMD 1201081, TLR9 agonists, squamous cell carcinoma of the head and neck, First line subjects, recurrent/metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to potential safety concerns in combination with platinum-based therapies
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- First posted
- 26 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Part 1) | Experimental | Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab |
| Arm 2 (Expansion cohorts -Part 2 and Part 2a) | Experimental | Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
- Recurrent and/or metastatic SCCHN, not suitable for local therapy.
- At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).
- Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.
Key exclusion criteria (8 listed)
- Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.
- Nasopharyngeal carcinoma.
- Medical history of diagnosed interstitial lung disease.
- Known hypersensitivity against any of the components of the trial treatment.
- Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMD 1201081 + 5-FU + Cisplatin + Cetuximab3-6 subjects per cohort will receive EMD 1201081 as a weekly subcutaneous injection on Days 1, 8, and 15 in 3-week cycles at dose levels of 0.16, 0.32, and 0.48mg/kg, respectively until progression of disease, unacceptable toxicity, or subject refusal to continue in the trial. EMD 1201081 will always be given after (within 1 hour) completion of the cetuximab infusion and before the start of chemotherapy. | Drug | Arm 1 (Part 1) |
| EMD 1201081 + 5-FU + Cisplatin + CetuximabPart 2 seeks to enroll 12 subjects at the MTD of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab; furthermore, an additional 3 to 6 subjects for a total of 9 subjects will be accrued at the 0.16 mg/kg low dose level in Part 2a once the Part 1 0.16 mg/kg dose cohort has been accrued and it is deemed safe to proceed to the 0.32 mg/kg dose cohort. EMD 1201081 will always be given after (within 1 hour) completion of the cetuximab infusion and before the start of chemotherapy. | Drug | Arm 2 (Expansion cohorts -Part 2 and Part 2a) |
Primary outcome
Maximum-tolerated-dose (MTD) at 0.16 mg/kg cohort size testing
Time frame: 3 weeks
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Maximum-tolerated-dose (MTD) at 0.32 mg/kg cohort size testing
Time frame: 3 weeks
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Maximum-tolerated-dose (MTD) at 0.48 mg/kg cohort size testing
Time frame: 3 weeks
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline up to 49 days after last study drug administration
2 secondary outcomes
Number of subjects with best overall response
Time frame: 8 months
Pharmacokinetic parameters: Cmax, Tmax and AUC (0-t)
Time frame: Days 1, 8 and 15
Results and safety
The study was stopped early (reason given: Study terminated due to potential safety concerns in combination with platinum-based therapies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Jean-Pierre Delord principal investigator
Clinical Research Unit and Pharmacology Lab EA 3035, Institut Claudius Regaud, Toulouse, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMD 1201081 + 5-FU + Cisplatin + Cetuximab in people with Squamous Cell Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to potential safety concerns in combination with platinum-based therapies). Results are not available in the source record.
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?
Maximum-tolerated-dose (MTD) at 0.16 mg/kg cohort size testing (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2014.