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A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With INCB024360 or Placebo in Subjects With Unresectable or Metastatic Melanoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

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Trial Information

A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With INCB024360 or Placebo in Subjects With Unresectable or Metastatic Melanoma


Inclusion Criteria:



- Male or female subjects, aged 18 years or older with unresectable or metastatic
melanoma.

- A life expectancy of >12 weeks.

- Laboratory ranges and medical criteria met, as defined within the protocol.

- Subject may not have received more than 1 prior regimen of systematic treatment for
unresectable or metastatic melanoma.

- For Phase 2 period of the study only, Subjects must have archival tumor tissue
available and collected with the prior 6 months or accessible disease for
pre-treatment, study biopsy.

Exclusion Criteria:

- Pregnant or nursing women.

- Current investigational trial participation with another investigational product or
subjects who have received any anticancer medications within 21 days prior to
screening (6 weeks for mitomycin-C or nitrosoureas.)

- Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had
Serotonin Syndrome after receiving one or more serotonergic drugs.

- Subjects who have ever received prior therapy with anti-CTLA-4 antibody, anti PD-1,
or an experimental immune system-targeted therapy.

- Subjects with protocol-specified active autoimmune process except vitiligo or
thyroiditis.

- Subjects with concurrent conditions that would jeopardize the safety of the safety of
the subject or compliance with the protocol.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.

Outcome Time Frame:

Baseline and minimally every 3 weeks until discontinuation or death (estimated timeframe to be 29 months from first patient enrolled to last patient discontinued or dead).

Safety Issue:

Yes

Principal Investigator

Lance Leopold, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Incyte Corporation

Authority:

United States: Food and Drug Administration

Study ID:

INCB 24360-201

NCT ID:

NCT01604889

Start Date:

March 2012

Completion Date:

February 2015

Related Keywords:

  • Metastatic Melanoma
  • Melanoma, Skin Cancer, Oncology
  • Melanoma

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Miami, Florida  33176
Philadelphia, Pennsylvania  19104