A PHASE 2, OPEN LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TICILIMUMAB IN PATIENTS WITH ADVANCED REFRACTORY AND/OR RELAPSED MELANOMA

• Conditions: Melanoma; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 14.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2005-002826-70-IT
• Lead Sponsor: PFIZER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

1. Histologically confirmed melanoma that is surgically incurable and either: · Stage III melanoma (AJCC 6th edition) including locally relapsed, in-transit lesions or draining nodes OR · Stage IV melanoma (M1a, M1b or M1c) 2. Prior treatment must include one, and not more than one, systemic therapy for the treatment of metastatic disease. Prior (first-line) systemic regimen for the treatment of metastatic melanoma must contain interleukin-2, dacarbazine and/or temozolamide or interferon-a. Patient must have received at least one cycle at full dose. 3. Documented disease progression after the last dose of prior therapy. Previously treated patients will include patients whose disease progressed during previous treatment (refractory), recurred following previous treatment (relapsed) or patients who could not tolerate previous treatment due to unacceptable toxicity and subsequently progressed (see Section 4.3.1). 4. A minimum of one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >/= 2.0 cm using conventional techniques or >/=1.0 cm with spiral CT scan. If the measurable disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology. Clinically detected lesions will only be considered measurable when they are superficial (eg, skin nodules) and the longest diameter is >/=2 cm. Palpable lymph nodes >2.0 cm should be demonstrable by CT scan. Tumor lesions that are situated in a previously irradiated area will be considered measurable if progression is documented following completion of radiation therapy. NOTE: As a point of clarification for this study, skin lesion(s) selected as target lesions will be accurately measured, and longest diameter will be at least 1.0 cm. Care should be exercised during biopsy procedures to prevent the alteration of the longest diameter of the selected skin lesion(s). Documentation by color photography, including a ruler to document the size of the target lesion(s), is required. 5. ECOG performance status (PS) 0 or 1 (see Appendix B). 6. Age >/=18 years. 7. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to enrollment, defined as: · Absolute neutrophil count >/=1.5 x 10(x9) cells/L · Platelets >/=100 x 10(x9)/L · Hemoglobin >/=10 g/dL · Aspartate and alanine aminotransferases (AST, ALT) /=60 mL/min 8. Serum lactic acid dehyrdrogenase (LDH) Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosed with melanoma of ocular origin. 2. Received treatment for cancer, including immunotherapy, within one month prior to enrollment (dosing). 3. Received any prior vaccine therapy for the treatment of melanoma. 4. Received any prior CTLA4-inhibiting agent. 5. Previously randomized to Pfizer study A3671009: A Phase 3, Open Label, Randomized Comparative Study of Ticilimumab and Either Dacarbazine or Temozolomide in Patients with Advanced Melanoma. 6. History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.). Active vitiligo or a history of vitiligo will not be a basis for exclusion. 7. History of, or clinically apparent hepatitis B or hepatitis C. 8. History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin. 9. History of uveitis or melanoma-associated retinopathy. 10. Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment (Note: inhaled or topical steroids in standard doses are allowed). 11. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 12. Any serious, uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment. 13. Brain metastases. Radiological documentation of absence of brain metastases at screening is required for all patients. 14. History of other malignancies, except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years. 15. Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and 6 months after. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within 72 hours prior to enrollment. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.

Study & Design

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