A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients withUntreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine With Placebo.Revised Protocol 04, Incorporates Administrative Letters 01, 02 & 03, Amendment 02, Amendment 06 and Amendment 07.Revised Protocol 06 incorporating Administrative letters 01, 02 & 03, Amendments 02, 06, 07, 08 and 09.
- Conditions
- Stage III (Unresectable) or IV Melanoma
- Registration Number
- EUCTR2005-006082-14-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1) Willing and able to give written informed consent;
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 = 16 weeks;
6) ECOG performance status of 0 or 1 (see Protocol 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 = 2500/uL
• ANC = 1000/uL
• Platelets = 75 x 103/uL
• Hemoglobin = 9 g/dL
• Creatinine = 2.5x ULN
• AST = 3 x ULN for patients without liver metastasis = 5 x ULN for patients with liver metastasis
• Bilirubin = 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;
11) Men and women > 18 years of age (or, = 16, if allowable per local regulatory
authority).
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
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;
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 of the protocol); 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;
15) Prisoners or patients who are compulsorily detained
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