Granulocyte Macrophage-Colony Stimulating Factor and Ipilimumab as Therapy in Melanoma

Conditions

• Malignant Melanoma, Metastatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) — BIOLOGICAL
  GM-CSF will be administered subcutaneously daily for 14 days in a dose of 125 µg/m2 beginning on D1 of each 21-day cycle for 8 cycles until month 6. Maintenance therapy will begin at month 6 and will consist 14 days of GM-CSF repeated every 3 months for up to 2 years or until disease progression, whichever occurs first.
• Ipilimumab — BIOLOGICAL
  Patients will be treated with 4 courses of ipilimumab administered every 3 weeks intravenously in a dose of 10 mg/kg, with appropriate stopping/de-escalation rules. Maintenance therapy will begin at month 6 and will consist of ipilimumab in the same dose administered at the end of cycle 4 repeated every 3 months for up to 2 years or until disease progression, whichever occurs first.

Study Details

The study is an open-label, single arm single Center Phase II study to evaluate the safety and efficacy of the combination of Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF, Leukine) and Ipilimumab (Yervoy) as therapy for patients with unresectable metastatic malignant melanoma.

Key Dates

Start date

May 31, 2011

Status verified

Mar 2020

Primary completion

May 31, 2014

Completion

May 31, 2015

Study Design

Enrollment

29 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single arm open label
  GM-CSF and Ipilimumab

Primary Outcome Measure

Disease control rate at 24 weeks as defined by the immune-related Response Criteria (irRC) [ Time Frame: 24 weeks ]

Locations (2)

Find similar trials in San Francisco, CA