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)
1. Signed and dated written informed consent prior to any trial-specific procedure.
2. Male or female, age ≥ 18 years.
3. Histologically confirmed squamous cell carcinoma of the head and neck that is
recurrent and/or metastatic; documented in the medical record.
4. History of progressing disease on a first-line cytotoxic chemotherapy regimen such as
5-FU + cisplatin, taxanes, etc. for their R/M SCCHN. (A history of chemotherapy/
radiation therapy for localized disease does not count as a first-line regimen.)
5. The subject is suited for systemic therapy in the opinion of the Investigator.
6. At least one radiographically documented lesion assessable according to RECIST 1.0.
Lesions in previously irradiated areas should be measurable (i.e. the lesion must be
adequately measurable in at least one dimension; longest diameter to be recorded as ≥
2 cm by conventional techniques or ≥ 1 cm by spiral CT scan). If the sole site of
measurable disease is in a prior radiation field, there must be unequivocal evidence
of progression at ≥ 8 weeks since the completion of radiation or a positive biopsy.
7. ECOG performance status of 0 or 1.
8. If female, either post-menopausal, surgically sterile, or having a negative urine or
serum pregnancy test (β-HCG) at screening and practicing medically accepted
contraception. If male, practicing contraception if 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.
9. Recovered from previous toxicities of prior cytotoxic regimen to CTCAE Grade 1 (with
the exception of alopecia).
10. Hemoglobin ≥ 9 g/dL (without transfusion support, no transfusion within 7 days of
11. Neutrophils ≥ 1.5 x 10(9)/L.
12. Platelets ≥ 100 x 10(9)/L.
13. PT/PTT ≤ 1.5 times the upper limit of normal for the site, unless there is
therapeutic anti-coagulation (see below; INR values should be converted to PT for
14. Serum creatinine ≤ 1.5 times the upper limit of normal for the site.
15. ALT and AST ≤ 3 times the upper limit of normal for the site.
16. Be willing and able to comply with the protocol procedures for the duration of the
1. History of prior exposure to cetuximab or panitumumab or any other approved or
investigational anti-EGFR agents.
2. Undifferentiated nasopharyngeal carcinoma.
3. Chemotherapy, radiotherapy or any investigational agents within 4 weeks of first dose
of trial medication.
4. Major surgical or planned procedure within 30 days prior to first dose of trial
medication (isolated biopsies are not counted as major surgical procedures).
5. Other active malignancy besides non-metastatic basal cell or squamous cell carcinoma
of the skin or second primary squamous cell carcinoma of the head and neck.
6. Impaired cardiac function (e.g. left ventricular ejection fraction < 45% defined by
echocardiograph or other study), history of uncontrolled serious arrhythmia, unstable
angina pectoris, congestive heart failure (NYHA III and IV), myocardial infarction
within the last 12 months prior to trial entry, signs of pericardial effusion.
7. Hypertension uncontrolled by standard pharmacologic therapies.
8. History of diagnosed interstitial lung disease.
9. Patient requires systemic anti-coagulation (e.g. warfarin > 10 mg/day).
10. Pregnancy or breast feeding.
11. Legal incapacity or limited legal capacity.
12. Significant medical or psychiatric disease which makes the trial inappropriate for
the subject in the Investigator's opinion.
13. Any brain metastasis and/or leptomeningeal disease (known or suspected).
14. Significant pre-existing immune deficiency such as infection by HIV (documented or
15. Clinically significant ongoing infection.
16. Known hypersensitivity to the trial treatments.
17. Participation in another clinical trial within the past 30 days.
18. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such.
19. Other significant disease that in the Investigator's opinion would exclude the
subject from the trial.