EUCTR2005-006082-14-ATActive, not recruitingNot Applicable
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, incorporating Administrative Letter 01, Administrative Letter 02, Administrative Letter 03, Amendment 02, Amendment 06 and Amendment 07.
Bristol-Myers Squibb International Corporation0 sites500 target enrollmentStarted: November 13, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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