Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

• Conditions: Merkel Cell Carcinoma; MedDRA version: 18.0Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000445-79-AT
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-30
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Signed written informed consent
• Age 18 years and above
• Histologically proven MCC as defined in the protocol
•Progressive disease after receiving 1 line of chemotherapy for metastatic MCC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Estimated life expectancy of more than 12 weeks
• Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST Version 1.1 (including skin lesions)
• Adequate hematological, hepatic and renal function
• Effective contraception for both male and female subjects if the risk of conception exists
• Fresh Biopsy or Archival Tumor Tissue
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

1. Participation in another clinical trial within the past 30 days
2. Concurrent treatment with a nonpermitted drug
3. Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints) such as
antiprogrammed death 1 (PD-1), anti-PD-L1, or anticytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody
4. Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy [with the exception of palliative bone-directed radiotherapy, or radiotherapy administered on non-target superficial lesions], immune therapy, or cytokine therapy except for erythropoietin). Radiotherapy administered to superficial lesions is not allowed if such lesions are considered target lesions in the efficacy evaluation or may influence the efficacy evaluation of the investigational agent
5. Major surgery for any reason, except diagnostic biopsy, within 4 weeks and/or if the subject has not fully recovered from the surgery within 4 weekss
6. Concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of trial treatment. Short-term administration of systemic steroids (that is, for allergic reactions or the management of immune-related adverse events [irAE]) while on study is allowed. Note: Subjects receiving bisphosphonate are eligible provided treatment was initiated at least 14 days before the first dose of avelumab
7. Subjects with active central nervous system (CNS) metastases are excluded. Subjects with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 2 months, and do not require continued steroid therapy 8. Previous malignant disease (other than MCC) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ
9. Prior organ transplantation, including allogeneic stem-cell transplantation
10. Known history of testing positive for HIV or known acquired immunodeficiency syndrome (AIDS) or any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
11. Active or history of any autoimmune disease (except for subjects with vitiligo) or immunodeficiencies that required treatment with systemic immunosuppressive drugs
12. Known severe hypersensitivity reactions to monoclonal antibodies (Grade = 3 NCI-CTCAE v 4.0), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
13. Persisting toxicity related to prior therapy Grade > 1 NCI-CTCAE v 4.0; however, sensory neuropathy Grade = 2 is acceptable 14. Pregnancy or lactation
15. Known alcohol or drug abuse
16. Clinically significant (that is, 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
17. All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the Investigator, might impair the subject’s tolerance of trial treatment
18. Any psychiatric condition that would prohibit the understanding or rendering of informed consent
19. Legal incapacity or limited legal capacity
20. Nononcology vaccine therapies for preve

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified