OPEN, MULTI-CENTER PHASE II TRIAL OF EXTENDED OR FOLLOW-UP TREATMENT WITH IPILIMUMAB (MDX-010) ADMINISTERED AS MONOTHERAPY TO PATIENTS PREVIOUSLY IN PROTOCOLS WITH IPILIMUMAB (MDX-010)

Not Applicable

• Conditions: -C43 Malignant melanoma of skin; Malignant melanoma of skin; C43

• Registration Number: PER-062-07
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

• Have experienced PD after clinical benefit; and
• Have achieved a clinical benefit (SD, PR or CR) in Week 12 or after it in a previous / original study or, only for Protocol CAI84022, have manifested disease progression before Week 12 or after clinical benefit (SD, PR or CR) in the previous / original protocol.
• Patients who received any dose of ipilimumab in a previous / original study that has been completed; and have
• Achieved an SD or improved (PR or CR), without progression or relapse at the time of admission to the complementary study.
• Patients who received any dose of ipilimumab in a previous / original study that has been completed;
• They were in the follow-up phase of the previous / original study;
.

Exclusion Criteria

• Have not manifested unacceptable toxicity that requires discontinuation of ipilimumab;
• They did not consider themselves eligible to enter Groups A or B or refused treatment as patients of Groups A or B at the time of selection in this complementary study, but gave their consent for follow-up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified