Phase II Study to Determine Predictive Markers of Response to MDX-010 (BMS-734016)

Phase 2

Withdrawn

• Conditions: nresectable Stage III or IV Malignant Melanoma; Unresectable Stage III or IV Malignant Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12606000010594
• Lead Sponsor: Bristol-Myers Squibb Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma). A pre- and post-treatment fresh core or excision tumour biopsy must be provided.

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify candidate markers predictive of response and/or serious toxicity to MDX-010 (BMS-734016). [ Tumour response measured starting at week 12 through week 24. Those continuing on therapy after week 24 have tumour responses evaluated every 3 months.]

Secondary Outcome Measures

Name	Time	Method
Safety & tumour response.[Safety evaluated on a continuous and ongoing basis.]