Clinical Trials /

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

NCT03589651

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
  • Official Title: A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-102
  • NCT ID: NCT03589651

Conditions

  • Unresectable or Metastatic Solid Tumors

Interventions

DrugSynonymsArms
INCMGA00012Group A
EpacadostatINCB024360Group A
INCB050465Group B

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Group AExperimentalINCMGA00012 with epacadostat.
  • INCMGA00012
  • Epacadostat
Group BExperimentalINCMGA00012 with INCB050465.
  • INCMGA00012
  • INCB050465

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of treatment-emergent adverse events
Time Frame:Up to approximately 30 months
Safety Issue:
Description: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

Measure:Cmax of INCMGA00012 when given in combination with immune therapies
Time Frame:Up to approximately 4 months
Safety Issue:
Description:Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measure:Tmax of INCMGA00012 when given in combination with immune therapies
Time Frame:Up to approximately 4 months
Safety Issue:
Description:Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measure:Cmax of epacadostat when given in combination with INCMGA00012
Time Frame:Up to approximately 4 months
Safety Issue:
Description:Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measure:Tmax of epacadostat when given in combination with INCMGA00012
Time Frame:Up to approximately 4 months
Safety Issue:
Description:Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measure:Cmax of INCB050645 when given in combination with INCMGA00012
Time Frame:Up to approximately 4 months
Safety Issue:
Description:Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measure:Tmax of INCB050645 when given in combination with INCMGA00012
Time Frame:Up to approximately 4 months
Safety Issue:
Description:Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Measure:Overall response rate
Time Frame:Up to approximately 30 months
Safety Issue:
Description: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.
Measure:Duration of response
Time Frame:Up to approximately 30 months
Safety Issue:
Description: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.
Measure:Progression-free survival
Time Frame:Up to approximately 30 months
Safety Issue:
Description: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.
Measure:Overall survival
Time Frame:Up to approximately 30 months
Safety Issue:
Description:Defined as the time from randomization to death due to any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Solid tumors
  • locally advanced unresectable tumor
  • metastatic solid tumors

Last Updated