Phase 2
N=107
EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Carcinoma of the Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01040832 ↗Enrolled (actual)
107
Serious AEs
46.7%
Results posted
Jul 2014
Primary outcome: Primary: Progression-free Survival (PFS) Time: Independent Read Assessments — 1.5; 1.9 months — p=0.793
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab (Drug); EMD 1201081 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EMD Serono
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Time: Independent Read Assessments |
1.5; 1.9 | 0.793 |
| SECONDARY Percentage of Participants With Objective Response: Independent Read Assessments |
5.7; 5.7 | >0.999 |
| SECONDARY Percentage of Participants With Disease Control: Independent Read Assessments |
37.7; 43.4 | 0.557 |
| SECONDARY Overall Survival (OS) Time |
6.3 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
52; 53; 27; 23 | — |
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).
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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 (= ] 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
Data sourced from ClinicalTrials.gov (NCT01040832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.