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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01604889
Recruitment Status : Terminated (Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.)
First Posted : May 24, 2012
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study design includes an open-label, dose escalation phase followed by a blinded, randomized phase, which combines INCB024360 (an oral IDO1 inhibitor) with an approved therapy and compares to approved therapy plus placebo in metastatic melanoma patients.

Condition or disease Intervention/treatment Phase
Melanoma Drug: INCB024360 Drug: Placebo Drug: ipilimumab Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : March 2012
Primary Completion Date : December 27, 2016
Study Completion Date : December 27, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: INCB024360 300 mg
300 mg twice daily (BID) in combination with ipilimumab
Drug: INCB024360 Drug: ipilimumab
Doses to be determined following the completion of Phase I of the study
Placebo Comparator: Placebo in combination with ipilimumab Drug: Placebo
Placebo
Drug: ipilimumab
ipilimumab 3 mg/kg IV
Experimental: INCB024360 25 mg
25 mg BID in combination with ipilimumab
Drug: INCB024360 Drug: ipilimumab
Doses to be determined following the completion of Phase I of the study
Experimental: INCB024360 50 mg
50 mg BID in combination with ipilimumab
Drug: INCB024360 Drug: ipilimumab
Doses to be determined following the completion of Phase I of the study
Experimental: INCB024360 75 mg
75 mg once a day (QD) in combination with ipilimumab
Drug: INCB024360 Drug: ipilimumab
Doses to be determined following the completion of Phase I of the study


Outcome Measures

Primary Outcome Measures :
  1. 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). ]
  2. 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). ]

Secondary Outcome Measures :
  1. 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). ]
  2. 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). ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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 received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-PD-1, anti- PD-L1 and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604889


Locations
United States, California
Los Angeles, California, United States
United States, Florida
Miami, Florida, United States
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Lance Leopold, M.D. Incyte Corporation
More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01604889     History of Changes
Other Study ID Numbers: INCB 24360-201
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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