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Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

NCT ID: NCT03348904

Last Updated: 2019-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-27

Study Completion Date

2018-05-22

Brief Summary

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The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A

Nivolumab plus epacadostat in combination with platinum doublet

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.

Epacadostat

Intervention Type DRUG

Epacadostat administered orally at the protocol-defined dose twice daily.

Carboplatin

Intervention Type DRUG

Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Cisplatin

Intervention Type DRUG

Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Gemcitabine

Intervention Type DRUG

Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Paclitaxel

Intervention Type DRUG

Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Pemetrexed

Intervention Type DRUG

Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.

Arm B

Platinum doublet chemotherapy

Group Type ACTIVE_COMPARATOR

Carboplatin

Intervention Type DRUG

Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Cisplatin

Intervention Type DRUG

Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Gemcitabine

Intervention Type DRUG

Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Paclitaxel

Intervention Type DRUG

Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Pemetrexed

Intervention Type DRUG

Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.

Arm C

Nivolumab plus placebo in combination with platinum doublet chemotherapy.

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.

Placebo

Intervention Type DRUG

Matching placebo for epacadostat administered orally twice daily.

Carboplatin

Intervention Type DRUG

Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Cisplatin

Intervention Type DRUG

Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Gemcitabine

Intervention Type DRUG

Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Paclitaxel

Intervention Type DRUG

Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Pemetrexed

Intervention Type DRUG

Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.

Interventions

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Nivolumab

Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.

Intervention Type DRUG

Epacadostat

Epacadostat administered orally at the protocol-defined dose twice daily.

Intervention Type DRUG

Placebo

Matching placebo for epacadostat administered orally twice daily.

Intervention Type DRUG

Carboplatin

Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Intervention Type DRUG

Cisplatin

Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Intervention Type DRUG

Gemcitabine

Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Intervention Type DRUG

Paclitaxel

Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Intervention Type DRUG

Pemetrexed

Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.

Intervention Type DRUG

Other Intervention Names

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BMS-936558 INCB024360

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
* No prior treatment with systemic anti-cancer therapy for Stage IV disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
* Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1.
* Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization.

Exclusion Criteria

* Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy.
* Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.
* Untreated central nervous system (CNS) metastases.
* Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory.
* Carcinomatous meningitis.
* Active, known or suspected autoimmune disease.
* Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1 targeted agent, or any other antibody or drug targeting T cell co-stimulation or checkpoint pathways.
* History of allergy or hypersensitivity to platinum-containing compounds or study drug components.
* Physical and laboratory test findings outside the protocol-defined range.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sridhar K. Rabindran, PhD

Role: STUDY_DIRECTOR

Bristol-Myers Squibb Research and Development

Locations

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Pacific Cancer Medical Center, Inc

Anaheim, California, United States

Site Status

Cancer Center of Kansas

Wichita, Kansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CA2099NC/ECHO-309

Identifier Type: -

Identifier Source: org_study_id

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