A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

Lung Cancer Clinical Trial

Official title:

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318277
• Other study ID #: INCB 24360-203 / ECHO-203
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 5, 2015
• Est. completion date: October 16, 2020

Study information

• Verified date: January 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: October 16, 2020
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects, age 18 years or older

• Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors

• Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment

Exclusion Criteria:

• Laboratory and medical history parameters not within protocol-defined range

• Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose

• Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)

• Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication

• Has an active or inactive autoimmune process

• Evidence of interstitial lung disease or active, non-infectious pneumonitis

• Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis

• Untreated central nervous system (CNS) metastases or CNS metastases that have progressed

• Currently pregnant or breastfeeding

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Solid Tumors
• UC (Urothelial Cancer)

Intervention

Drug:
• MEDI4736
MEDI4736 administered intravenously (IV) every two weeks (q2w)
• INCB024360
INCB024360: Oral daily dosing

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Incyte Corporation	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment	Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Primary	Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Measured every 8 weeks for duration of study treatment [approximately 12 months]
Secondary	Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1	ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Measured every 8 weeks for duration of study treatment [approximately 6 months]
Secondary	Phase 2: Number of Treatment-Emergent Adverse Events	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment	Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Secondary	Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression	Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.	Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Secondary	Phase 1 and 2: Progression-free Survival as Measured by the Duration From the Date of Enrollment Until the Earliest Date of Disease Progression or Death		Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Secondary	Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration		Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Secondary	Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration		Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Secondary	Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve		Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Secondary	Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)		Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].