A multi-center single arm phase II study of MDX-010 BMS-734016 monotherapy in patients with previously treated unresectable stage III or IV melanoma. - ND
- Conditions
- Treatment of unresectable stage III or IV melanoma.MedDRA version: 6.1Level: HLTClassification code 10027156
- Registration Number
- EUCTR2005-002051-41-IT
- Lead Sponsor
- BRISTOL-M.SQUIBB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Signed written informed consent 1 Willing and able to give written informed consent; Target population 2 Histologic diagnosis of malignant melanoma; 3 Measurable, unresectable Stage III or IV melanoma; 4 Patient must have progressed during or after at least one prior therapy containing at least one of the following dacarbazine, paclitaxel, carboplatin, fotemustine, or temozolamide. 5 At least 4 weeks since treatment chemotherapy, biochemotherapy, surgery, radiation, immunotherapy, etc. , for melanoma and recovered from any clinically significant toxicity experienced during treatment; 6 Life expectancy 8805; 4 months; 7 ECOG performance status of 0 or 1 see Appendix 4 ; 8 Required values for initial laboratory tests WBC 8805; 2500/uL ANC 8805; 1500/uL Platelets 8805; 100 x 103/uL Hemoglobin 8805; 10 g/dL Hematocrit 8805; 30 Creatinine 8804; 2 x ULN AST 8804; 2 x ULN Bilirubin 8804; 2 x ULN, except patients with Gilbert s Syndrome, who must have a total bilirubin less than 3.0 mg/mL; 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. Age and Sex 10 Men and women 8805; 18 years of age; Women of childbearing potential WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized. Date 01-Jul-2005 55 Approved v1.0 930011454 1.0 MDX-010 CA184008 BMS-734016 Clinical Protocol WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization hysterectomy, bilateral tubal ligation or bilateral oophorectomy or is not postmenopausal defined as amenorrhea 8805; 12 consecutive months; or women on hormone replacement therapy HRT with documented serum follicle stimulating hormone FSH level 35 IU/mL . Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods diaphragm, condoms, spermacides to prevent pregnancy or practicing abstinence or where partner is sterile e.g. vasectomy , should be considered to be of childbearing potential. 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
Any of the following criteria will disqualify the patient from participation Sex and Reproductive Status 1 WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire period of the study and for up to 8 weeks after the study; 2 WPCBP using a prohibited contraceptive method Not Applicable 3 Women who are pregnant or breastfeeding; 4 Women with a positive pregnancy test at enrollment or prior to study drug administration; 5 Sexually active fertile men whose partners are WOCBP, unless using an adequate method of birth control; Target Disease Exceptions 6 Any other malignancy form 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, carcinoma in situ of the cervix; 7 Ocular melanoma; Medical History and Concurrent Disease 8 Active, symptomatic or asymptomatic untreated central nervous system CNS metastasis including metastasis identified incidentally during screening MRI or contrast CT ; 9 Prior treatment with an anti-CTLA4 antibody; Date 01-Jul-2005 56 Approved v1.0 930011454 1.0 MDX-010 CA184008 BMS-734016 Clinical Protocol 10 Autoimmune disease Patients with a history of Inflammatory Bowel Disease are excluded from this study as are patients with a history of autoimmune disease e.g. Systemic Lupus Erythematosus, vasculitis, infiltrating lung disease whose possible progression during treatment would be considered by the Investigator to be unacceptable. Patients with a history of well-controlled and/or clinically manageable autoimmune disease e.g. vitiligo, well-controlled thyroid disease, mild psoriasis may be considered for inclusion in consultation with the CRO; 11 Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea; Prohibited Therapies and/or Medications 12 Concomitant therapy with any of the following IL-2, interferon or other non-study anti-melanoma immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids used in the management of cancer or non-cancer-related illnesses ; 13 Previous treatment with other investigational products within 30 days; 14 Previous enrollment in another MDX-010 BMS-734016 clinical trial or prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist; Other Exclusion Criteria 15 Inability to provide adequate informed consent; 16 Prisoners or patients who are compulsorily detained involuntarily incarcerated for treatment of either a psychiatric or physical e.g., infectious disease illness must not be enrolled in 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