NCT02318277

Brief Summary

The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

January 5, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 29, 2020

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

4.6 years

First QC Date

November 19, 2014

Results QC Date

August 28, 2020

Last Update Submit

January 7, 2022

Conditions

Solid TumorsHead and Neck CancerLung CancerUC (Urothelial Cancer)

Outcome Measures

Primary Outcomes (2)

  • Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

    Duration of study treatment and up to 90 days after the last dose [approximately 3 years]

  • Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured every 8 weeks for duration of study treatment [approximately 12 months]

Secondary Outcomes (8)

  • Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1

    Measured every 8 weeks for duration of study treatment [approximately 6 months]

  • Phase 2: Number of Treatment-Emergent Adverse Events

    Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]

  • Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression

    Measured every 8 weeks for duration of active study treatment [approximately 24 months]

  • Phase 1 and 2: Progression-free Survival as Measured by the Duration From the Date of Enrollment Until the Earliest Date of Disease Progression or Death

    Measured every 8 weeks for duration of active study treatment [approximately 24 months]

  • Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration

    Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1

  • +3 more secondary outcomes

Study Arms (1)

MEDI4736 + INCB024360

EXPERIMENTAL

MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified

Drug: MEDI4736Drug: INCB024360

Interventions

MEDI4736DRUG

MEDI4736 administered intravenously (IV) every two weeks (q2w)

MEDI4736 + INCB024360
INCB024360DRUG

INCB024360: Oral daily dosing

MEDI4736 + INCB024360

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, age 18 years or older
  • Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
  • Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment

You may not qualify if:

  • Laboratory and medical history parameters not within protocol-defined range
  • Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose
  • Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
  • Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
  • Has an active or inactive autoimmune process
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
  • Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
  • Currently pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Port Saint Lucie, Florida, United States

Location

Unknown Facility

Sarasota, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Huntersville, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Related Publications (1)

  • Naing A, Algazi AP, Falchook GS, Creelan BC, Powderly J, Rosen S, Barve M, Mettu NB, Triozzi PL, Hamm J, Zhou G, Walker C, Dong Z, Patel MR. Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors. Cancer. 2023 Jan 1;129(1):71-81. doi: 10.1002/cncr.34512. Epub 2022 Oct 30.

    PMID: 36309837DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsLung Neoplasms

Interventions

durvalumabepacadostat

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Study Director
Organization
Incyte Corporation
medinfo@incyte.com
855-463-3463

Study Officials

  • Lance Leopold, MD

    Incyte Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 17, 2014

Study Start

January 5, 2015

Primary Completion

August 28, 2019

Study Completion

October 16, 2020

Last Updated

January 13, 2022

Results First Posted

December 29, 2020

Record last verified: 2022-01

Locations

US(13)