Purpose

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
  • Phase 1: Subjects with advanced or metastatic solid tumors.
  • Phase 1: Subjects who have disease progression after treatment with available therapies.
  • Phase 2: Subjects with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC and are considered refractory to prior PD-1/L1 therapy.
  • Presence of measurable disease based on RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

Exclusion Criteria

  • Laboratory and medical history parameters not within the Protocol-defined range
  • Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
  • Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
  • Active autoimmune disease.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
  • Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
  • Known history of human immunodeficiency virus (HIV); HIV 1/2 antibodies.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
INCAGN01949 + Nivolumab
INCAGN01949 combined with nivolumab.
  • Drug: Nivolumab
    Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
  • Drug: INCAGN01949
    In Phase 1 subjects will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
Experimental
INCAGN01949 + Ipilimumab
INCAGN01949 combined with ipilimumab.
  • Drug: INCAGN01949
    In Phase 1 subjects will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment.
  • Drug: Ipilimumab
    Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Experimental
INCAGN01949 + Nivolumab + Ipilimumab
INCAGN01949 combined with nivolumab and ipilimumab.
  • Drug: Nivolumab
    Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
  • Drug: Ipilimumab
    Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
  • Drug: INCAGN01949
    In Phase 1 subjects will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.

More Details

NCT ID
NCT03241173
Status
Active, not recruiting
Sponsor
Incyte Biosciences International Sàrl

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.