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

Incyte

Status and phase: Completed; Phase 1

Conditions: Unresectable or Metastatic Solid Tumors

Treatments: Drug: Retifanlimab; Drug: INCB050465; Drug: Epacadostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03589651

INCMGA 0012-102

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Group A

Experimental group

Description:

INCMGA00012 with epacadostat.

Treatment:

Drug: Epacadostat

Drug: Retifanlimab

Group B

Experimental group

Description:

INCMGA00012 with INCB050465.

Treatment:

Drug: Retifanlimab

Drug: INCB050465