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

Status: Active

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.

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.

Locations & Contacts

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: In review
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Corporation

Trial IDs

Primary ID INCMGA 0012-102
Secondary IDs NCI-2018-01942
Clinicaltrials.gov ID NCT03589651