A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

Incyte

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Malignancies

Treatments: Drug: Ipilimumab; Drug: INCAGN01949; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03241173

INCAGN 1949-201

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 7 patient groups

Phase 1, Dose Escalation: INCAGN01949 + Nivolumab

Experimental group

Description:

INCAGN01949 (70, 200, 350, or 700 milligrams \[mg\]) combined with nivolumab 240 mg in participants with advanced or metastatic select solid tumors

Treatment:

Drug: Nivolumab

Drug: INCAGN01949

Phase 1, Dose Escalation: INCAGN01949 + Ipilimumab

Experimental group

Description:

INCAGN01949 (70, 200, 350, or 700 mg) combined with ipilimumab 1 mg/kilogram (kg) in participants with advanced or metastatic select solid tumors

Treatment:

Drug: Ipilimumab

Drug: INCAGN01949

Phase 1, Dose Escalation: INCAGN01949 + Nivolumab + Ipilimumab

Experimental group

Description:

INCAGN01949 combined with nivolumab 3 mg/kg and ipilimumab 1 mg/kg in participants with advanced or metastatic select solid tumors

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Drug: INCAGN01949

Phase 1, Safety Expansion: INCAGN01949 + Nivolumab

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: INCAGN01949

Phase 1, Safety Expansion: INCAGN01949 + Nivolumab + Ipilimumab

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Drug: INCAGN01949

Phase 2, Part A: INCAGN01949 + nivolumab

Experimental group

Description:

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)

Treatment:

Drug: Nivolumab

Drug: INCAGN01949

Phase 2, Part B: INCAGN01949; INCAGN01949 + nivolumab; INCAGN01949 + nivolumab + ipilimumab

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Drug: INCAGN01949