Vanderbilt Clinical Trials

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	Drug: INCAGN01949 In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1. Drug: Nivolumab Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
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	Drug: INCAGN01949 In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1. Drug: Ipilimumab Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
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	Drug: INCAGN01949 In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1. 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.
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	Drug: INCAGN01949 In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1. Drug: Nivolumab Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
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	Drug: INCAGN01949 In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1. 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.
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)	Drug: INCAGN01949 In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1. Drug: Nivolumab Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
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	Drug: INCAGN01949 In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1. 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.

More Details

Status: Completed
Sponsor: Incyte Biosciences International Sàrl

Study Contact

Notice

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