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OpenTrials
Completed

NCT Number: NCT03589651

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Angeles Clinic and Research Institute, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retifanlimab

Drug

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.

Epacadostat

Drug

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 names: INCB024360, INCMGA00012

INCB050465

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2018
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.