A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide

Not Applicable

• Conditions: -C439 Malignant melanoma of skin, unspecified; Malignant melanoma of skin, unspecified; C439

• Registration Number: PER-031-06
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a) Written informed consent, voluntarily signed and dated. It must be obtained before performing the procedures related to the protocol.
b) Able to comply with visits / procedures required by the protocol.
c) Life expectancy of at least 4 months.
d) ECOG 0-1 performance status score.
e) Histological or cytological diagnosis of non-resectable malignant melanoma of Stage III or IV.
f) Disease susceptible of measurement.
g) It must have been at least 4 weeks since the last chemotherapy, immunotherapy, hormonal therapy, radiotherapy or major surgery and the beginning of the protocol therapy.
h) The toxicity related to the previous therapy must have returned to ≤ grade 1, to the baseline or be considered irreversible.
i) Men and women 18 years and older. Women of childbearing age (WOCBP) should be using an adequate contraceptive method. The WOCBP must have a negative pregnancy test within 72 hours prior to the start of the study medication.
j) Values ​​adequate for initial laboratory tests.

Exclusion Criteria

a) WOCBPs that are not willing or able to use an acceptable method to avoid pregnancy during the entire study period and for at least 12 weeks after the study.
b) WOCBPs that use a prohibited method of contraception.
c) Women who are pregnant or breastfeeding.
d) Women with a positive pregnancy test at the time of enrollment or before administration of the study drug.
e) Sexually active fertile men who are unwilling or unable to use a barrier contraceptive or whose partners are WOCBP who do not use a method of birth control from the moment of enrollment and for 12 weeks after participation in the study.
f) Any other malignant disease that the patient has suffered for less than 5 years.
g) Ocular melanoma.
h) Central nervous system (CNS) metastasis untreated and active.
i) Autoimmune disease.
j) Any underlying medical condition, which makes the administration of the study drug dangerous or hinders the interpretation of adverse events.
k) Positive screening tests for HIV, HepB and HepC. If the positive results are not indicative of true active or chronic infection, the patient can be admitted after being discussed and agreed with the BMS Medical Monitor.
l) Therapies and / or prohibited medications.
m) Exposure to any of the products under investigation within 4 weeks prior to Day 1 of the treatment.
n) Pre-treatment with an anti-CLTA-4 antibody.
o) Use of any immunosuppressive treatment within 4 weeks prior to Day 1 of treatment.
p) Concomitant therapy with any of the following: IL-2, interferon or other anti-melanoma immunotherapy regimens that are not in the study; cytotoxic chemotherapy; immunosuppressive agents; other therapies in research or the chronic use of systemic corticosteroids.
q) Concomitant chemotherapy is prohibited.
r) Prisoners or patients who are required to be detained for the treatment of either a psychiatric or physical illness should not be enrolled in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified