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Randomized Phase 2 Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-05/ECHO-306-05)

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ClinicalTrials.gov Identifier: NCT03322566
Recruitment Status : Active, not recruiting
First Posted : October 26, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Pembrolizumab Drug: Epacadostat Drug: Platinum-based chemotherapy Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-05/ECHO-306-05)
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm 1
Epacadostat + pembrolizumab + platinum-based chemotherapy
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475

Drug: Epacadostat
Epacadostat administered orally twice daily.
Other Name: INCB024360

Drug: Platinum-based chemotherapy
Investigator will select one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin.

Active Comparator: Arm 2
Placebo + pembrolizumab + platinum-based chemotherapy
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475

Drug: Platinum-based chemotherapy
Investigator will select one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin.

Drug: Placebo
Matching placebo administered orally twice daily.




Primary Outcome Measures :
  1. Objective response rate of epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy [ Time Frame: Approximately 24 months ]
    Defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1


Secondary Outcome Measures :
  1. Progression-free survival of epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy [ Time Frame: Approximately 24 months ]
    Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.

  2. Overall survival of epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy [ Time Frame: Up to 60 months ]
    Defined as the time from randomization to death due to any cause.

  3. Duration of response of epacadostat + pembrolizumab + chemotherapy and placebo + pembrolizumab + chemotherapy [ Time Frame: Approximately 24 months ]
    Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.

  4. Safety and tolerability of epacadostat + pembrolizumab + chemotherapy and placebo + pembrolizumab + chemotherapy as measured by the number of participants experiencing adverse events (AEs) [ Time Frame: Up to 37 months ]
    An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  5. 3. Safety and tolerability of epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy as measured by the number of participants discontinuing study drug due to AEs [ Time Frame: Up to 37 months ]
    An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
  • Measurable disease based on RECIST 1.1
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function per protocol-defined criteria.
  • Provide tumor tissue sample.

Exclusion Criteria:

  • Known untreated central nervous system metastases and/or carcinomatous meningitis
  • History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
  • Symptomatic ascites or pleural effusion.
  • Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  • Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
  • Use of protocol-defined prior/concomitant therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322566


  Show 94 Study Locations
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
Study Director: Lance Leopold, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03322566     History of Changes
Other Study ID Numbers: KEYNOTE-715-05/ECHO-306-05
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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 1 (PD-1) inhibitor
indoleamine 2
3-dioxygenase 1 (IDO1) inhibitor
chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents