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

Primary Purpose

Melanoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Epacadostat

Placebo

ipilimumab

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Skin Cancer, Oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Epacadostat 300 mg

Placebo in combination with ipilimumab

Epacadostat 25 mg

Epacadostat 50 mg

Epacadostat 75 mg

Arm Description

300 mg twice daily (BID) in combination with ipilimumab

25 mg BID in combination with ipilimumab

50 mg BID in combination with ipilimumab

75 mg once a day (QD) in combination with ipilimumab

Outcomes

Primary Outcome Measures

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

Phase 2: Overall survival.

Secondary Outcome Measures

Preliminary efficacy as assessed by tumor response.

Evaluation of progression free survival.

Full Information

NCT ID

NCT01604889

First Posted

May 9, 2012

Last Updated

March 19, 2019

Sponsor

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01604889

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Terminated

Why Stopped

Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.

Study Start Date

March 2012 (Actual)

Primary Completion Date

December 27, 2016 (Actual)

Study Completion Date

December 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Incyte Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Melanoma, Skin Cancer, Oncology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epacadostat 300 mg

Arm Type

Experimental

Arm Description

300 mg twice daily (BID) in combination with ipilimumab

Arm Title

Placebo in combination with ipilimumab

Arm Type

Placebo Comparator

Arm Title

Epacadostat 25 mg

Arm Type

Experimental

Arm Description

25 mg BID in combination with ipilimumab

Arm Title

Epacadostat 50 mg

Arm Type

Experimental

Arm Description

50 mg BID in combination with ipilimumab

Arm Title

Epacadostat 75 mg

Arm Type

Experimental

Arm Description

75 mg once a day (QD) in combination with ipilimumab

Intervention Type

Drug

Intervention Name(s)

Epacadostat

Other Intervention Name(s)

INCB024360

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Intervention Type

Drug

Intervention Name(s)

ipilimumab

Intervention Description

ipilimumab 3 mg/kg IV

Intervention Type

Drug

Intervention Name(s)

ipilimumab

Intervention Description

Doses to be determined following the completion of Phase I of the study

Primary Outcome Measure Information:

Title

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).

Title

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 Measure Information:

Title

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).

Title

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lance Leopold, M.D.

Organizational Affiliation

Incyte Corporation

Official's Role

Study Director

Facility Information:

City

Los Angeles

State/Province

California

Country

United States

City

Miami

State/Province

Florida

Country

United States

City

Tampa

State/Province

Florida

Country

United States

City

Chicago

State/Province

Illinois

Country

United States

City

Durham

State/Province

North Carolina

Country

United States

City

Philadelphia

State/Province

Pennsylvania

Country

United States

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30894212

Citation

Gibney GT, Hamid O, Lutzky J, Olszanski AJ, Mitchell TC, Gajewski TF, Chmielowski B, Hanks BA, Zhao Y, Newton RC, Maleski J, Leopold L, Weber JS. Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma. J Immunother Cancer. 2019 Mar 20;7(1):80. doi: 10.1186/s40425-019-0562-8.

Results Reference

derived

Learn more about this trial

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

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