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

Purpose

The study design includes an open-label, dose escalation phase followed by a blinded, randomized phase, which combines INCB024360 (an oral IDO inhibitor) with an approved therapy and compares to approved therapy plus placebo in metastatic melanoma patients.

Condition	Intervention	Phase
Metastatic Melanoma	Drug: INCB024360 in combination with ipilimumab Drug: Placebo in combination with ipilimumab	Phase 1 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Ipilimumab

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability. [ 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). ] [ Designated as safety issue: Yes ]
Phase 2: Overall survival. [ Time Frame: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe to be 29 months from first patient enrolled to last patient death). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Preliminary efficacy as assessed by tumor response. [ Time Frame: Baseline and every nine weeks (3 cycles) thereafter (estimated timeframe is that each patient will be on study for 11 months). ] [ Designated as safety issue: No ]
Evaluation of progression free survival. [ Time Frame: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe is that patients will progress after 11 months). ] [ Designated as safety issue: No ]

Estimated Enrollment:	136
Study Start Date:	March 2012
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: INCB024360 300 mg BID in combination with ipilimumab	Drug: INCB024360 in combination with ipilimumab INCB024360 300mg BID + ipilimumab 3 mg/kg IV
Experimental: INCB024360 600 mg BID in combination with ipilimumab	Drug: INCB024360 in combination with ipilimumab INCB024360 600mg BID + ipilimumab 3 mg/kg IV
Experimental: INCB024360 in combination with ipilimumab	Drug: INCB024360 in combination with ipilimumab Doses to be determined following the completion of Phase I of the study -- active treatment with INCB024360 300 or 600 mg BID.
Placebo Comparator: Placebo in combination with ipilimumab	Drug: Placebo in combination with ipilimumab Placebo + ipilimumab 3 mg/kg IV

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604889

Contacts

Contact: Incyte Corporation Call Center

1.855.463.3463

Locations

United States, California
	Recruiting
Los Angeles, California, United States
United States, Florida
	Recruiting
Tampa, Florida, United States
United States, Illinois
	Not yet recruiting
Chicago, Illinois, United States
United States, Pennsylvania
	Recruiting
Philadelphia, Pennsylvania, United States
	Not yet recruiting
Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

Lance Leopold, M.D.

Incyte Corporation

More Information

No publications provided

Responsible Party:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT01604889 History of Changes
Other Study ID Numbers:	INCB 24360-201
Study First Received:	May 9, 2012
Last Updated:	December 13, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

Melanoma, Skin Cancer, Oncology

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms

Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013