A Clinical Trial: Adjuvant Low-dose Ipilimumab + Nivolumab After Resection of Melanoma Macrometastases

Conditions

• Stage IIIC Skin Melanoma
• Stage IV Skin Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• nivolumab — DRUG
  low fixed dose ipilimumab in combination with nivolumab
• ipilimumab — DRUG
  low fixed dose ipilimumab in combination with nivolumab

Study Details

Nivolumab (OpdivoTM, BMS), a human IgG-4 anti-PD-1 monoclonal antibody has demonstrated anti-tumor activity in patients with advanced melanoma. The investigators postulate that patients with melanoma nivolumab have a comparable tumor response rate at a dose range of 0.1 to 10 mg/kg q2wks. Ipilimumab (YervoyTM, BMS), a human IgG-1 anti-CTLA-4 monoclonal antibody improves the survival of patients with advanced melanoma. Adjuvant therapy with ipilimumab improves the relapse-free survival after complete resection of high-risk stage III melanoma (EORTC 18071). Combined treatment with ipilimumab plus nivolumab improves the tumor response rate and overall survival of patients with advanced melanoma but is associated with a higher incidence of immune related adverse events (CheckMate 067).Nivolumab and ipilimumab have distinct immunological mechanisms that can be revealed by analyzing TCR usage in blood lymphocytes.

Key Dates

Start date

Mar 31, 2016

Status verified

Jan 2019

Primary completion

Dec 31, 2018

Completion

Jan 31, 2019

Study Design

Enrollment

56 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: IpNiv
  low fixed dose ipilimumab plus low fixed dose nivolumab

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2year ]