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

Conditions

• Unresectable or Metastatic Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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.

Study Details

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.

Key Dates

Start date

Aug 17, 2018

Status verified

Feb 2023

Primary completion

Nov 21, 2022

Completion

Nov 21, 2022

Study Design

Enrollment

83 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A
  INCMGA00012 with epacadostat.
• Experimental: Group B
  INCMGA00012 with INCB050465.

Primary Outcome Measure

Number of treatment-emergent adverse events [ Time Frame: Up to approximately 30 months ]

Locations (9)

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