Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

Not Applicable

Completed

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

• Registration Number: PER-056-07
• Lead Sponsor: BRISTOL MYERS SQUIBB PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-21
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

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

Inclusion Criteria

1) Disposition and ability to give written informed consent.
2) Have a histological diagnosis of malignant melanoma.
3) Stage III untreated and unresectable melanoma with macroscopic lymph nodes N3 or metastasis in transit / satellites or stage IV melanoma.
4) Measurable / evaluable disease within 28 days before the first dose of the experimental drug.
5) Life expectancy> 16 weeks.
6) General condition according to the ECOG scale of 0 or 1.
7) Have a complete set of digital images and radiographic images of the lesions in the initial moment.
8) Have the required values for the initial laboratory tests.
9) Negative screening tests for HIV, hepatitis B and hepatitis C.
10) Accessible for treatment and monitoring.
11) Men and women of> 18 years.

Exclusion Criteria

1) WOCBPs that are not willing or able to use an acceptable method to prevent pregnancy during the entire study period and up to 8 weeks after the study.
2) Women who are pregnant or breastfeeding.
3) Women with a positive pregnancy test.
4) Sexually active fertile men whose partners are WOCBP, unless they use adequate contraceptive methods.
5) Evidence of cerebral metastases in brain images.
6) Any other neoplasm of which the patient has been free of disease for less than 5 years.
7) Ocular or primary mucosal melanoma.
8) Autoimmune disease.
9) Any underlying medical or psychiatric illness.
10) Previous or concomitant treatment with some antineoplastic, immunosuppressive agents, surgery or radiotherapy, other experimental anticancer therapies, or the chronic use of corticosteroids.
11) Any treatment with non-oncological vaccines used for the prevention of infectious diseases.
12) Previous treatment with a CD137 agonist or a CTLA-4 inhibitor or agonist.
13) Previous participation in another clinical trial with ipilimumab.
14) Treatment with other experimental products within 4 weeks prior to randomization in this study.
15) Prisoners or persons who are mandatorily detained for the treatment of any psychiatric or physical illness should not be randomized in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified