Clinical trial NCT03589651: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unresectable or Metastatic Solid Tumors
Keywords: Solid tumors
locally advanced unresectable tumor
metastatic solid tumors
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-18
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of treatment-emergent adverse events
timeFrame: Up to approximately 30 months
Secondary outcomes:
measure: Cmax of INCMGA00012 when given in combination with immune therapies
timeFrame: Up to approximately 4 months
measure: Tmax of INCMGA00012 when given in combination with immune therapies
timeFrame: Up to approximately 4 months
measure: Cmax of epacadostat when given in combination with INCMGA00012
timeFrame: Up to approximately 4 months
measure: Tmax of epacadostat when given in combination with INCMGA00012
timeFrame: Up to approximately 4 months
measure: Cmax of INCB050645 when given in combination with INCMGA00012
timeFrame: Up to approximately 4 months
measure: Tmax of INCB050645 when given in combination with INCMGA00012
timeFrame: Up to approximately 4 months
measure: Overall response rate
timeFrame: Up to approximately 30 months
measure: Duration of response
timeFrame: Up to approximately 30 months
measure: Progression-free survival
timeFrame: Up to approximately 30 months
measure: Overall survival
timeFrame: Up to approximately 30 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida - Shands Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of Nj
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Upmc Cancercenter
state: Pennsylvania
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
References: