An Investigational Immuno-therapy Study of BMS-986205 Combined with Nivolumab, Compared to Nivolumab by itself, in Patients with Advanced Melanoma

Phase 1

• Conditions: Metastatic or Unresectable Melanoma that is Previously Untreated; MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002499-14-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-23
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 933

Inclusion Criteria

Per Revised Protocol 01, enrollment in the current study has been
stopped as of 19-Apr-2018

- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
- Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
- Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
- Measurable disease
Are the trial subjects under 18? yes
Number of subjects for this age range: 28
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 634
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 271

Exclusion Criteria

Per Revised Protocol 01, enrollment in the current study has been
stopped as of 19-Apr-2018

- Active brain metastases or leptomeningeal metastases
- Uveal or ocular melanoma
- Participants with active, known, or suspected autoimmune disease
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

Study & Design

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