A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
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
- Advanced Malignancies
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Phase 1, Dose Escalation: INCAGN01949 + Nivolumab |
INCAGN01949 (70, 200, 350, or 700 milligrams [mg]) combined with nivolumab 240 mg in participants with advanced or metastatic select solid tumors |
|
Experimental Phase 1, Dose Escalation: INCAGN01949 + Ipilimumab |
INCAGN01949 (70, 200, 350, or 700 mg) combined with ipilimumab 1 mg/kilogram (kg) in participants with advanced or metastatic select solid tumors |
|
Experimental Phase 1, Dose Escalation: INCAGN01949 + Nivolumab + Ipilimumab |
INCAGN01949 combined with nivolumab 3 mg/kg and ipilimumab 1 mg/kg in participants with advanced or metastatic select solid tumors |
|
Experimental Phase 1, Safety Expansion: INCAGN01949 + Nivolumab |
Run-in with INCAGN01949 (70, 200, or 350 mg) x 2 doses, followed by INCAGN01949 (70, 200, or 350 mg) combined with nivolumab 240 mg in participants with advanced or metastatic select solid tumors |
|
Experimental Phase 1, Safety Expansion: INCAGN01949 + Nivolumab + Ipilimumab |
Run-in with INCAGN01949 x 2 doses, followed by INCAGN01949 combined with nivolumab 3 mg/kg and ipilimumab 1 mg/kg in participants with advanced or metastatic select solid tumors |
|
Experimental Phase 2, Part A: INCAGN01949 + nivolumab |
INCAGN01949 combined with nivolumab in programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) refractory participants with gastric cancer, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC) |
|
Experimental Phase 2, Part B: INCAGN01949; INCAGN01949 + nivolumab; INCAGN01949 + nivolumab + ipilimumab |
INCAGN01949 alone, combined with nivolumab, and combined with nivolumab and ipilimumab in PD-1/L1 refractory participants with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC |
|
More Details
- Status
- Completed
- Sponsor
- Incyte Biosciences International Sàrl