A Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma

Conditions

• NSCLC (Non-small Cell Lung Carcinoma)
• UC (Urothelial Cancer)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Epacadostat — DRUG
  Epacadostat tablets
• Atezolizumab — DRUG
  Atezolizumab intravenously

Study Details

This study evaluated the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that were previously treated with platinum-based chemotherapy and Stage IV urothelial carcinoma who failed a platinum-based chemotherapy regimen. The study was conducted in two phases. The dose escalation phase did utilize a 3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose (PAD) of the combination. This was followed by a dose expansion phase, which was comprised of three cohorts. Expansion Cohorts 1 \& 2 will further evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab administered in combination.

Key Dates

Start date

Jan 27, 2015

Status verified

Apr 2026

Primary completion

Nov 8, 2017

Completion

Nov 8, 2017

Study Design

Enrollment

29 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Epacadostat 25 mg+Atezolizumab 1200 mg
  Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
• Experimental: Epacadostat 50 mg+Atezolizumab 1200 mg
  Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
• Experimental: Epacadostat 75 mg+Atezolizumab 1200 mg
  Epacadostat 75 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
• Experimental: Epacadostat 100 mg+Atezolizumab 1200 mg
  Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
• Experimental: Epacadostat 200 mg+Atezolizumab 1200 mg
  Epacadostat 200 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
• Experimental: Epacadostat 300 mg+Atezolizumab 1200 mg
  Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Continuously for duration of study participation and up to 42 days after the last dose [approximately 8 months ]

Locations (6)

Find similar trials in Scottsdale, AZ

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