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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01604889
First received: May 9, 2012
Last updated: September 3, 2014
Last verified: September 2014
  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:


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: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB024360 300 mg
300 mg twice daily (BID) in combination with ipilimumab
Drug: INCB024360 in combination with ipilimumab
Doses to be determined following the completion of Phase I of the study
Placebo Comparator: Placebo in combination with ipilimumab Drug: Placebo in combination with ipilimumab
Placebo + ipilimumab 3 mg/kg IV
Experimental: INCB024360 25 mg
25 mg BID in combination with ipilimumab
Drug: INCB024360 in combination with 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 in combination with 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 in combination with ipilimumab
Doses to be determined following the completion of Phase I of the study

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Miami, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, North Carolina
Recruiting
Durham, North Carolina, 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: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Melanoma, Skin Cancer, Oncology

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014