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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-17

Study Completion Date

2022-11-21

Brief Summary

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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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Detailed Description

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Conditions

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Unresectable or Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

INCMGA00012 with epacadostat.

Group Type EXPERIMENTAL

Retifanlimab

Intervention Type 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

Intervention Type 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.

Group B

INCMGA00012 with INCB050465.

Group Type EXPERIMENTAL

Retifanlimab

Intervention Type 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.

INCB050465

Intervention Type 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.

Interventions

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Retifanlimab

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.

Intervention Type DRUG

Epacadostat

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.

Intervention Type DRUG

INCB050465

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.

Intervention Type DRUG

Other Intervention Names

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INCB024360 INCMGA00012

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No