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

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03348904
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 2
• Locations: 2
• Arms: 3
• Actual Duration (Months): 4.8
• Patient Per Site: 1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Nivolumab; Drug: Epacadostat; Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pemetrexed	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
• Actual Study Start Date: Dec 27, 2017
• Actual Primary Completion Date: May 22, 2018
• Actual Study Completion Date: May 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Nivolumab plus epacadostat in combination with platinum doublet	Drug: Nivolumab; Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.; Other Names: BMS-936558 ; Drug: Epacadostat; Epacadostat administered orally at the protocol-defined dose twice daily.; Other Names: INCB024360 ; Drug: Carboplatin; Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Cisplatin; Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Gemcitabine; Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Paclitaxel; Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; 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.
Active Comparator: Arm B Platinum doublet chemotherapy	Drug: Carboplatin; Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Cisplatin; Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Gemcitabine; Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Paclitaxel; Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; 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.
Experimental: Arm C Nivolumab plus placebo in combination with platinum doublet chemotherapy.	Drug: Nivolumab; Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.; Other Names: BMS-936558 ; Drug: Placebo; Matching placebo for epacadostat administered orally twice daily.; Drug: Carboplatin; Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Cisplatin; Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Gemcitabine; Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; Drug: Paclitaxel; Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.; 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.

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) [Approximately 38 months]

   Defined as the time from randomization to the date of death from any cause.

2. Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) [Approximately 25 months]

   Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

1. Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) [Approximately 25 months]

   Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.

2. Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) [Approximately 25 months]

   Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.

3. Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) [Approximately 38 months]

   Defined as the time from randomization to the date of death from any cause.

4. Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) [Approximately 25 months]

   Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.

5. Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) [Approximately 25 months]

   Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.

6. Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) [Approximately 25 months]

   Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

• Other protocol inclusion criteria may apply

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.

• Other protocol exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Cancer Medical Center, Inc	Anaheim	California	United States	92801
2	Cancer Center of Kansas	Wichita	Kansas	United States	67214

Sponsors and Collaborators

• Incyte Corporation
• Bristol-Myers Squibb

Investigators

• Study Director: Sridhar K. Rabindran, PhD, Bristol-Myers Squibb Research and Development

Study Documents (Full-Text)

• Study Protocol - Oct 23, 2017

More Information

Publications

None provided.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT03348904
• Other Study ID Numbers: CA2099NC/ECHO-309
• First Posted: Nov 21, 2017
• Last Update Posted: Jun 13, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Incyte Corporation: Non-small cell lung cancer; programmed cell death protein 1 (PD-1) antibody; indoleamine 2,3-dioxygenase (IDO) inhibitor
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Gemcitabine; Paclitaxel; Carboplatin; Nivolumab; Pemetrexed

Study Results

Participant Flow

Recruitment Details	Approximately 630 participants were planned to be randomized. Prior to the termination of the study, 2 participants were randomized to the Platinum Doublet Chemotherapy arm (Arm B) and treated.

Arm/Group Title	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy	Platinum Doublet Chemotherapy	Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Period Title: Overall Study
STARTED	0	2	0
COMPLETED	0	1	0
NOT COMPLETED	0	1	0

Baseline Characteristics

Arm/Group Title	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy	Platinum Doublet Chemotherapy	Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy	Total
Arm/Group Description	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Total of all reporting groups
Overall Participants	0	2	0	2
Age (Count of Participants)
<=18 years	0 NaN	0 0%	0 NaN	0 0%
Between 18 and 65 years	0 NaN	2 100%	0 NaN	2 100%
>=65 years	0 NaN	0 0%	0 NaN	0 0%
Sex: Female, Male (Count of Participants)
Female	0 NaN	0 0%	0 NaN	0 0%
Male	0 NaN	2 100%	0 NaN	2 100%
Race/Ethnicity, Customized (Count of Participants)
White or Caucasian	0 NaN	2 100%	0 NaN	2 100%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Description	Defined as the time from randomization to the date of death from any cause.
Time Frame	Approximately 38 months

Outcome Measure Data

Analysis Population Description

All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.

Arm/Group Title	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy	Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Measure Participants	0	0

2. Primary Outcome

Title	Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Description	Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.
Time Frame	Approximately 25 months

Outcome Measure Data

Analysis Population Description

All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.

Arm/Group Title	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy	Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Measure Participants	0	0

3. Secondary Outcome

Title	Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Description	Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.
Time Frame	Approximately 25 months

Outcome Measure Data

Analysis Population Description

All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.

Arm/Group Title	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy	Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Measure Participants	0	0

4. Secondary Outcome

Title	Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Description	Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Time Frame	Approximately 25 months

Outcome Measure Data

Analysis Population Description

All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.

Arm/Group Title	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy	Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.	Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Measure Participants	0	0

5. Secondary Outcome

Title	Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Description	Defined as the time from randomization to the date of death from any cause.
Time Frame	Approximately 38 months

Outcome Measure Data

Analysis Population Description

All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.

Arm/Group Title	Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Measure Participants	0

6. Secondary Outcome

Title	Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Description	Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.
Time Frame	Approximately 25 months

Outcome Measure Data

Analysis Population Description

All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.

Arm/Group Title	Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Measure Participants	0

7. Secondary Outcome

Title	Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Description	Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.
Time Frame	Approximately 25 months

Outcome Measure Data

Analysis Population Description

All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.

Arm/Group Title	Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Measure Participants	0

8. Secondary Outcome

Title	Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Description	Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Time Frame	Approximately 25 months

Outcome Measure Data

Analysis Population Description

All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.

Arm/Group Title	Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
Measure Participants	0

Adverse Events

Time Frame	From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.
Adverse Event Reporting Description	All treated participants.
Arm/Group Title	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy		Platinum Doublet Chemotherapy		Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Arm/Group Description	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.		Platinum Doublet Chemotherapy included the following: Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.		Nivolumab plus placebo in combination with platinum doublet chemotherapy included: Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Optional continuation maintenance was available every 3 weeks, if eligible.
All Cause Mortality
	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy		Platinum Doublet Chemotherapy		Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Serious Adverse Events
	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy		Platinum Doublet Chemotherapy		Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Metabolism and nutrition disorders
Dehydration	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
Back pain	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Osteomyelitis	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Nivolumab + Epacadostat/Platinum Doublet Chemotherapy		Platinum Doublet Chemotherapy		Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		2/2 (100%)		0/0 (NaN)
Blood and lymphatic system disorders
Anaemia	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Thrombocytopenia	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Gastrointestinal disorders
Nausea	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Vomiting	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Constipation	0/0 (NaN)		2/2 (100%)		0/0 (NaN)
General disorders
Pyrexia	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Investigations
Weight decreased	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
Flank pain	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Muscle spasms	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Nervous system disorders
Peripheral sensory neuropathy	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Psychiatric disorders
Anxiety	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Vascular disorders
Hypotension	0/0 (NaN)		1/2 (50%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.