NCT03085914

A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was an open-label, nonrandomized, Phase 1/2 study designed to determine the safety, tolerability, and efficacy of epacadostat when given in combination with pembrolizumab and 7 different chemotherapy regimens described as Treatment Groups A through G below (see Study Drug and Background Therapies, Dose, and Mode of Administration). Phase 1 consisted of a 3 + 3 + 3 design intended to determine the MTD or PAD of epacadostat when given in combination with pembrolizumab and chemotherapy; efficacy was also explored. Phase 2 was designed to enroll efficacy expansion cohorts to further evaluate the safety, tolerability, and efficacy of epacadostat at the MTD or PAD (as selected in Phase 1) when given in combination with pembrolizumab and chemotherapy. Each efficacy expansion cohort was to enroll participants with 1 specific type of advanced or metastatic solid tumor. Additional cohorts (ie, the mandatory biopsy cohorts) were designed to evaluate changes in the tumor microenvironment in participants with any advanced or metastatic solid tumor who had progressed on previous therapy with a PD-1 or a PD-L1 inhibitor. No participants were enrolled in any Phase 2 efficacy expansion cohort, or in any Phase 2 mandatory biopsy cohort receiving Treatment A, B, F, or G. Phase 2 mandatory biopsy cohort participants received Treatments C, D, or E (ie, were included in Treatment Groups C, D, or E). Participants were assigned to a treatment group based on the chemotherapy regimen most appropriate for their tumor type.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Epacadostat	Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
DRUG	Pembrolizumab	Pembrolizumab
DRUG	Oxaliplatin	Oxaliplatin
DRUG	Leucovorin	Leucovorin
DRUG	5-Fluorouracil	5-Fluorouracil
DRUG	Gemcitabine	Gemcitabine
DRUG	nab-Paclitaxel	nab-Paclitaxel
DRUG	Carboplatin	Carboplatin
DRUG	Paclitaxel	Paclitaxel
DRUG	Pemetrexed	Pemetrexed
DRUG	Cyclophosphamide	Cyclophosphamide
DRUG	Carboplatin	Carboplatin
DRUG	Cisplatin	Cisplatin
DRUG	5-Fluorouracil	5-FU
DRUG	Investigator's choice of platinum agent	Investigator's choice of platinum agent: carboplatin or cisplatin

Timeline

• Start date: 2017-05-02
• Primary completion: 2019-01-25
• Completion: 2020-07-13
• First posted: 2017-03-21
• Last updated: 2022-09-23
• Results posted: 2020-05-07

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study