Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of Ipilimumab Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients with Unresectable Stage III or IV Malignant MelanomaRevised Protocol 03 Incorporating Amendment 02, 03 and 05 (version 1.0, dated 12-Mar-07)+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0 dated 01-Aug-05)

• Conditions: MELANOMA

• Registration Number: EUCTR2005-002678-31-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-28
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Signed Informed Consent Form

2)Target population
a) Able to comply with visits/procedures required by the protocol.
b) Life expectancy of at least 4 months.
c) ECOG performance status score 0-1 (see Protocol Appendix 1).
d) Histologic or cytologic diagnosis of unresectable Stage III or IV malignant
melanoma (excluding ocular melanoma).
e) Measurable disease as defined in Protocol Section 3.3.3.2.
f) At least 4 Weeks must have elapsed since the last chemotherapy, immunotherapy,
hormonal therapy, radiotherapy or major surgery and the beginning of protocol
therapy. At least 6 Weeks for nitrosoureas, mitomycin C and liposomal doxorubicin.
g) Toxicity related to prior therapy must either have returned to = grade 1, baseline, or been deemed irreversible.

3) Age and Sex

a) Men and women, ages 18 and above.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before dosing, and while women are on study and for up to 3 months after last dose of study drug.
- WOCBP must have a negative pregnancy test within 72 hours prior to the start of study medication.
- Men must be willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if their sexual partners are WOCBP.

4) Required values for initial laboratory tests:
• WBC = 3000 x 1 000/mL
• ANC = 1500 x 1 000/mL
• Platelets = 100 x 1 000 000/mL
• Hemoglobin = 10 g/dL
• AST = 2.5 x ULN for patients without liver metastasis; = 5 x ULN for patients with liver metastasis
• Bilirubin = 1.5 x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/mL);
• Creatinine = 1.5 x ULN.
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) Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study.
b) WOCBP using a prohibited contraceptive method.
c) Women who are pregnant or breastfeeding.
d) Women with a positive pregnancy test on enrollment or prior to study drug administration.
e) Sexually active fertile men who are unwilling or unable to use a barrier contraceptive (eg, condom) or whose partners are WOCBP not using a method of birth control from the time of enrollment and for 12 Weeks after participation in the study.
2) Target Disease Exclusion
a) 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, carcinoma in situ of the cervix.
b) Ocular melanoma.
3) Medical History and Concurrent Diseases
a) Active, untreated central nervous system (CNS) metastasis (including metastasis identified during screening MRI or contrast CT).
b) 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 BMS Medical Monitor.
c) 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;
d) Positive screening tests for HIV, HepB, and HepC. If positive results are not indicative of true active or chronic infection, the patient can be admitted after discussion with and agreement by the BMS Medical Monitor.
4) Prohibited Therapies and/or Medications
a) Exposure to any investigational products within 4 Weeks prior to Day 1 of treatment.
b) Prior treatment with an anti-CTLA-4 antibody.
c) Use of any immunosuppressing treatments including corticosteroids (patients on stable doses of hormone replacement therapy are exempt), cyclosporine, mycophenolate mofetil (Cellcept) chemotherapy, radiation, etc, within 4 Weeks prior to Day 1 of treatment.
d) Concomitant therapy with any of the following: IL-2, interferon or other nonstudy
anti-melanoma immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (patients on stable doses of hormone replacement therapy are exempt).
e) While there is no limit to prior chemotherapy, concomitant chemotherapy is prohibited.
5) Prisoners or patients who are compulsorily detained.

Study & Design

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