Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors

Conditions

• Breast Cancer
• Colorectal Cancer (CRC)
• Endometrial Cancer
• Head and Neck Cancer
• Lung Cancer
• MMR-deficient Tumors
• Melanoma
• Pancreatic Cancer
• Renal Cell Carcinoma (RCC)
• Solid Tumors
• UC (Urothelial Cancer)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Pembrolizumab 200 mg IV Q3W.
• itacitinib — DRUG
  Itacitinib tablets administered orally once daily.
• INCB050465 — DRUG
  INCB050465 tablets administered orally once daily.

Study Details

This is an open-label, multicenter, Phase 1b platform study in subjects with advanced or metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part 2). Two treatment groups (Group A and Group B) will be evaluated Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each combination. Once the recommended dose has been identified in Part 1a, subjects with select solid tumor types will be enrolled into safety expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b) for each combination. Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate the combination in patients with non-small cell lung cancer (NSCLC) and urothelial cancer (UC).

Key Dates

Start date

Jan 25, 2016

Status verified

Mar 2022

Primary completion

Nov 7, 2019

Completion

Nov 20, 2020

Study Design

Enrollment

159 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: pembrolizumab + itacitinib
  Part 1a Group A will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days. Part 1b Group A-1 and Group A-2 will evaluate the MTD or PAD of itacitinib in combination with pembrolizumab in subjects with select solid tumors.
• Experimental: pembrolizumab + INCB050465
  Part 1a Group B will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days. Part 1b Group B-1 and Group B-2 will evaluate the MTD or PAD of INCB050465 in combination with pembrolizumab in subjects with select solid tumors. Part 2 will evaluate the combination of INCB050465 in combination with pembrolizumab in subjects with small cell lung cancer, non-small lung cancer and urothelial cancer.

Primary Outcome Measure

Part 1: Evaluation of safety and tolerability as measured by the frequency, duration, and severity of adverse events [ Time Frame: Duration of study treatment and up to 120 days after the last dose of study drug ]

Locations (17)

Find similar trials in San Francisco, CA

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