A Multi-center, Randomized, Double-blind, Two-Arm, Phase III Study in Patients with Untreated Stage III Unresectable or IV Melanoma Receiving Dacarbazine Plus 10mg/kg of Ipilimumab MDX-010 vs. Dacarbazine With Placebo - CA184-024
- Conditions
- MedDRA version: 6.1Level: HLTClassification code 10027156ntreated stage III unresectable or IV melanoma.
- Registration Number
- EUCTR2005-006082-14-IT
- Lead Sponsor
- Bristol Myers Squibb S.r.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
Signed written informed consent 1 Willing and able to give written informed consent; Target population 2 Histologic diagnosis of malignant melanoma; 3 Untreated unresectable Stage III melanoma with N3 macroscopic lymph nodes or in-transit/satellite metastases or Stage IV melanoma AJCC 2001 note that prior adjuvant melanoma therapy is permitted e.g., IFN therapy ; 4 Measurable/evaluable disease as per modified WHO criteria , within 28 days of first dose of study drug; 5 Life expectancy of 8805; 16 weeks; 6 ECOG performance status of 0 or 1 see Appendix 3 ; 7 Have the complete set of baseline i.e., Screening digital images of lesions and radiographic images, including, but not limited to brain, chest, abdomen pelvis and bone scans. All images must be of adequate quality; 8 Required values for initial laboratory tests WBC 8805; 2500/uL ANC 8805; 1000/uL Platelets 8805; 75 x 103/uL Hemoglobin 8805; 9 g/dL Creatinine 8804; 2.5x ULN AST 8804; 3 x ULN for patients without liver metastasis 8804; 5 x ULN for patients with liver metastasis Bilirubin 8804; 3x ULN, except patients with Gilbert s Syndrome, who must have a total bilirubin less than 3.0 mg/dL; 9 Negative Screening tests for HIV, HepB, and HepC. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement between the Investigator and the CRO Medical Monitor; 10 Accessible for treatment and Follow-Up; Age and Sex 11 Men and women 18 years of age or, 8805; 16, if allowable per local regulatory authority .
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Sex and Reproductive Status 1 WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study. 2 Women who are pregnant or breastfeeding 3 Women with a positive pregnancy test on enrollment or prior to study drug administration. 4 Sexually active fertile men whose partners are WOCBP, unless using an adequate method of birth control Medical History and Concurrent Diseases 5 Evidence of brain metastases on brain imaging i.e., MRI or contrast CT ; 6 Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix; 7 Primary ocular or mucosal melanoma; 8 Autoimmune disease Patients with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn s disease are excluded from this study as are patients with a history of symptomatic disease e.g., rheumatoid arthritis, systemic progressive sclerosis scleroderma , Systemic Lupus Erythematosus, autoimmune vasculitis e.g., Wegener s Granulomatosis ; 9 Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea; Prohibited Therapies and/or Medications 10 Prior or concomitant therapy with any anti-cancer agent, immunosuppressive agents, surgery or radiotherapy except as defined in Sections 6.2.8.3 and 6.2.8.4 ; other investigational anti-cancer therapies, or chronic use of systemic corticosteroids used in the management of cancer or non-cancer-related illnesses . Prior adjuvant therapy is not exclusionary; 11 Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks prior to or after any dose of ipilimumab or dacarbazine ; 12 Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist; 13 Previous participation in another ipilimumab MDX-010 clinical trial; 14 Treatment with other investigational products within the last 4 weeks prior to randomization into this study;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method