A study to assess the efficacy and safety of Nivolumab and Ipilimumab in the treatment of patients with Stage III or IV Melanoma. Patients will then receive Nivolumab until the end of the study.
- Conditions
- Stage III (Unresectable) or Stage IV MelanomaTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-001274-17-NO
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 533
a) Subjects with histologically-confirmed unresectable stage III or stage IV melanoma as per AJCC 2010 staging system, including mucosal and ocular melanoma, regardless of BRAF mutation status
b) Subjects are included if they are newly diagnosed with advanced/metastatic disease and have not received prior systemic treatment for their advanced disease.
Note: Prior adjuvant or neoadjuvant melanoma therapy (except anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if it was completed at least 6 weeks prior to study entry, and all related AEs have either returned to baseline or stabilized.
c) Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 6 weeks of first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least
2 weeks prior to study drug administration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 308
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 307
a) Active (symptomatic) and not treated brain metastases or leptomeningeal metastases.
b) Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti PD-L1 or anti-PD-L2, anti-CD-137 agents (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) for adjuvant, neo-adjuvant, or advanced melanoma treatment or as part of clinical trial (including those who have been randomized to blinded control)
c) Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
d) Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
e) All toxicities attributed to prior anti-cancer therapy other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method