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INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589651
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.

Condition or disease Intervention/treatment Phase
Unresectable or Metastatic Solid Tumors Drug: INCMGA00012 Drug: Epacadostat Drug: INCB050465 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
Actual Study Start Date : July 27, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Group A
INCMGA00012 with epacadostat.
Drug: INCMGA00012

Part 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose.

Part 2: INCMGA00012 at the recommended dose from Part 1.


Drug: Epacadostat

Part 1: Epacadostat at the protocol-defined starting dose administered orally twice daily, with dose escalation to determine the maximum tolerated dose.

Part 2: Epacadostat at the recommended dose from Part 1.

Other Name: INCB024360

Experimental: Group B
INCMGA00012 with INCB050465.
Drug: INCMGA00012

Part 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose.

Part 2: INCMGA00012 at the recommended dose from Part 1.


Drug: INCB050465
Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1.




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events [ Time Frame: Up to approximately 30 months ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.


Secondary Outcome Measures :
  1. Cmax of INCMGA00012 when given in combination with immune therapies [ Time Frame: Up to approximately 4 months ]
    Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.

  2. Tmax of INCMGA00012 when given in combination with immune therapies [ Time Frame: Up to approximately 4 months ]
    Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.

  3. Cmax of epacadostat when given in combination with INCMGA00012 [ Time Frame: Up to approximately 4 months ]
    Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.

  4. Tmax of epacadostat when given in combination with INCMGA00012 [ Time Frame: Up to approximately 4 months ]
    Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.

  5. Cmax of INCB050645 when given in combination with INCMGA00012 [ Time Frame: Up to approximately 4 months ]
    Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.

  6. Tmax of INCB050645 when given in combination with INCMGA00012 [ Time Frame: Up to approximately 4 months ]
    Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.

  7. Overall response rate [ Time Frame: Up to approximately 30 months ]
    Defined as the percentage of participants having 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 and modified RECIST v1.1 for immune-based therapeutics.

  8. Duration of response [ Time Frame: Up to approximately 30 months ]
    Defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first.

  9. Progression-free survival [ Time Frame: Up to approximately 30 months ]
    Defined as the time from the start of therapy until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first.

  10. Overall survival [ Time Frame: Up to approximately 30 months ]
    Defined as the time from randomization to death due to any cause.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy
  • Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
  • Willing to provide fresh or archival tumor tissue for correlative studies.
  • Eastern Cooperative Oncology Group performance status 0 to 1.
  • Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

  • Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
  • Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
  • Laboratory values outside the protocol-defined range at screening.
  • Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
  • Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
  • Evidence of interstitial lung disease or active, noninfectious pneumonitis.

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): NCT03589651


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com

Locations
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United States, California
The Angeles Clinic (Cedars-Sinai) Recruiting
Los Angeles, California, United States, 90025
Principal Investigator: Ani Balmanoukian         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Patricia LoRusso         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Thomas George         
United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Gini Fleming         
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
Principal Investigator: Janice Mehnert         
United States, New York
Roswell Park Comprehensive Cancer Center Recruiting
Buffalo, New York, United States, 14263
Principal Investigator: Christos Fountzilas         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Gregory Beatty         
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Jason Luke         
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Kyriakos Papadopoulos         
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Sadhna Shankar, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03589651    
Other Study ID Numbers: INCMGA 0012-102
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Solid tumors
locally advanced unresectable tumor
metastatic solid tumors
Additional relevant MeSH terms:
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Neoplasms