Trial document





This trial has been registered retrospectively.
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  DRKS00017255

Trial Description

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Title

A single arm phase II, open-label, multicenter trial to investigate the clinical activity and safety of avelumab in combination with cetuximab in subjects with unresectable stage III or stage IV cutaneous squamous cell carcinoma (cSCC)

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Trial Acronym

AliCe (Avelumab in combination with cetuximab)

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URL of the Trial

http:///

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Brief Summary in Lay Language

This is a single arm, national, multicenter, open-label, Phase II trial that will evaluate the efficacy and safety of avelumab in combination with cetuximab in patients with unresectable stage III or stage IV cSCC. The primary aim of this study is to determine whether the combination therapy has sufficient efficacy in terms of objective response rate for the treatment of patients with cSCC in stage III or IV.

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Brief Summary in Scientific Language

Evaluation of the efficacy and safety of Avelumab in combination with cetuximab in patients with unresectable cSCC in stage III or IV.

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Organizational Data

  •   DRKS00017255
  •   2019/08/13
  •   [---]*
  •   yes
  •   Approved
  •   8087, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   2018-001708-12 
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Health Condition or Problem studied

  •   cutaneous squamous cell carcinoma (cSCC), unresectable stage III or stage IV
  •   C44.9 -  Malignant neoplasm: Malignant neoplasm of skin, unspecified
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Interventions/Observational Groups

  •   Combined therapy of cetuximab and avelumab as intravenous infusions
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   No
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Primary Outcome

To evaluate efficacy in terms of objective response rate (ORR) after 3 months of combination therapy of avelumab and cetuximab

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Secondary Outcome

progression-free survival (PFS), duration of objective response (DOR), overall survival (OS), safety profile, Quality of Life (using QoL-C30)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2019/05/15
  •   52
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients may be included in the study only if they meet all the following criteria:
• Male or female subjects aged ≥ 18 years on day of signing informed consent
• Histologically proven cSCC in stage III, not amenable to surgery / curative radiation, or stage IV (according to the 8th AJCC edition; see chapter 18.6)
• ECOG performance status of 0 or 1
• Measurable disease, i.e. at least one measurable lesion per RECIST, v1.1
• Required values for initial laboratory tests:
o Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
o Platelet count ≥ 100 × 109/L
o Hemoglobin ≥ 9 g/dL (may have been transfused)
o Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN)
o ALT and AST ≤ 2.5 × ULN (for subjects with documented metastatic disease to the liver: ≤ 5 x ULN)
o Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
• No active or chronic infection with HIV, Hepatitis B or C
• Negative serum pregnancy test for women of childbearing potential
• Highly effective contraception for both male and female patients throughout the study and for at least 30 days after last dose of study medication administration if the risk of conception exists. Highly effective contraception has to be in line with the definition of the CTFG (Clinical Trial Facilitation Group) recommendation (see 18.7)
• Signed written informed consent and capacity of understanding the informed consent

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Exclusion Criteria

Patients will be excluded from the study for any of the following reasons:

• Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)
• Patients with brain metastases
• Current use of immunosuppressive medication, EXCEPT for the following:
o Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
o Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
o Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
• Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
• Active infection requiring systemic therapy
• Known history of testing positive for HIV or known acquired immunodeficiency syndrome
• Vaccination with any live vaccine (e.g. intranasal flu vaccine) within 4 weeks before the first dose of avelumab or planned vaccination with live vaccine during the trial
• Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
• Current other malignancies, except
o malignancies NOT requiring therapy such as B-CLL
o adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal carcinoma of the skin
• Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
• Radiotherapy within 14 days prior to first dose of study treatment with the exception of palliative bone-directed radiotherapy, or radiotherapy administered on non-target superficial lesions
• Any other systemic anti-tumor therapy in the last 4 weeks
• Patients who discontinued prior check-point inhibitor therapy due to adverse reactions
• Major surgery (excluding prior diagnostic biopsy) within 28 days prior to first dose of study treatment
• Cytokine therapy (except erythropoietin) within 28 days prior to first dose of study treatment
• Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator’s judgment are acceptable
• Currently participating in or having participated in the treatment phase of a study of an investigational agent or using an investigational device within 4 weeks before registration and/or during study participation
• Pregnancy or lactation period
• Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
• Known alcohol or drug abuse
• Legal incapacity or limited legal capacity
• Prior organ transplantation including allogeneic stem-cell transplantation

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Addresses

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    • Alcedis GmbH
    • Wincester Straße 3
    • 35394  Gießen
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Ralf  Gutzmer 
    • Carl Neuberg Str.1
    • 30625  Hannover
    • Germany
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    • Alcedis GmbH
    • Ms.  Dr.  Bettina  Storz-Arnold 
    • Wincester Straße 3
    • 35394  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Merck Serono GmbH
    • Alsfelder Straße 17
    • 64289  Darmstadt
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.