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

Active:	No
Cancer Type:	Colon/Rectal Cancer Lung Cancer Melanoma Stomach/ Gastric Cancer	NCT ID:	NCT02646748
Trial Phases:	Phase I	Protocol IDs:	39110-107 (primary) NCI-2016-00648 s15-00941
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Incyte Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT02646748

Summary

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).

Objectives

This is an open-label, Phase 1b, 3 Part (Part 1a, Part 1b, and Part 2), multi-center
study.

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 endometrial
cancer, gastric cancer, melanoma, microsatellite unstable (MSI) colorectal cancer or
other MMR-deficient tumors, non-small cell lung cancer, renal cell carcinoma, head and
neck squamous cell carcinoma, triple negative breast cancer, pancreatic ductal carcinoma,
or transitional cell carcinoma of the genitourinary tract 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).

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.