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

NCT03589651 | Completed Phase 1 FDA Drug

• 1 other identifier: INCMGA 0012-102
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 9

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.

Conditions

Unresectable or Metastatic Solid Tumors

Keywords

Solid tumors; locally advanced unresectable tumor; metastatic solid tumors

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events

  Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

  Up to approximately 30 months

Secondary Outcomes (10)

• Cmax of INCMGA00012 when given in combination with immune therapies

  Up to approximately 4 months

• Tmax of INCMGA00012 when given in combination with immune therapies

  Up to approximately 4 months

• Cmax of epacadostat when given in combination with INCMGA00012

  Up to approximately 4 months

• Tmax of epacadostat when given in combination with INCMGA00012

  Up to approximately 4 months

• Cmax of INCB050645 when given in combination with INCMGA00012

  Up to approximately 4 months

Study Arms (2)

Group A

EXPERIMENTAL

INCMGA00012 with epacadostat.

Drug: Retifanlimab; Drug: Epacadostat

Group B

EXPERIMENTAL

INCMGA00012 with INCB050465.

Drug: Retifanlimab; Drug: INCB050465

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.

Group A; Group B

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.

Also known as: INCB024360, INCMGA00012

Group A

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (9)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

University of Florida - Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Rutgers Cancer Institute of Nj

New Brunswick, New Jersey, 08901, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Upmc Cancercenter

Pittsburgh, Pennsylvania, 15232, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

epacadostat; parsaclisib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 18, 2018
• Study Start: August 17, 2018
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)