Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors
Public ClinicalTrials.gov record NCT02646748. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02646748
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 159 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 25, 2016 (Actual)
- Primary completion
- Nov 7, 2019 (Actual)
- Completion
- Nov 20, 2020 (Actual)
- Last update posted
- Mar 31, 2022
2016 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| John Wayne Cancer Institute at Providence Saint John's Health Center | Santa Monica | California | 90404 | — |
| Georgetown University Medical Center Lombardi CCC | Washington D.C. | District of Columbia | 20007 | — |
| Hematology-Oncology Associates of Treasure Coast | Port Saint Lucie | Florida | 37952 | — |
| Emory University, Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| University of Kentucky, Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| The Center for Cancer and Blood Disorders (RCCA MD LLC-Maryland Vidision) | Bethesda | Maryland | 20817 | — |
| Beth Israel Medical Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer institute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital System | Detroit | Michigan | 48202 | — |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| NYU Laura & Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Duke Cancer Institute | Durham | North Carolina | 27710 | — |
| UPMC CancerCenters, Hilman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| HOPE Cancer Center of East Texas | Tyler | Texas | 75701 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02646748, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 31, 2022 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02646748 live on ClinicalTrials.gov.