A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:June 9, 2016
End Date:February 15, 2021
Contact:Toll Free Number
Phone:1-888-577-8839

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A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)

This is a study of carboplatin and paclitaxel or nano particle albumin-bound paclitaxel
(nab-paclitaxel) with or without pembrolizumab (MK-3475, KEYTRUDA®) in adults with first line
metastatic squamous non-small cell lung cancer (NSCLC).

The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free
Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as
assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival
(OS).

After analysis of interim results was conducted, the protocol was amended (Amendment 5) to
allow participants the option to discontinue placebo in the control arm and to switch to
pembrolizumab in the event of documented progressive disease as assessed by central review.


Inclusion Criteria:

- Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or
M1b-American Joint Committee on Cancer [AJCC] 7th edition) squamous NSCLC.

- Has measurable disease based on RECIST 1.1 as determined by the local site
investigator/radiology assessment.

- Has not received prior systemic treatment for metastatic NSCLC.

- Has provided tumor tissue from locations not radiated prior to biopsy.

- Has a life expectancy of at least 3 months.

- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Status.

- Has adequate organ function.

- If female of childbearing potential, is willing to use an adequate method of
contraception for the course of the study through 120 days after the last dose of
study drug.

- If male with a female partner(s) of child-bearing potential, must agree to use an
adequate method of contraception starting with the first dose of study drug through
120 days after the last dose of study drug. Males with pregnant partners must agree to
use a condom; no additional method of contraception is required for the pregnant
partner.

Exclusion Criteria:

- Has non-squamous histology NSCLC.

- Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks prior to administration of pembrolizumab.

- Before the first dose of study drug: a) Has received prior systemic cytotoxic
chemotherapy for metastatic disease; b) Has received other targeted or biological
antineoplastic therapy (e.g., erlotinib, crizotinib, cetuximab) for metastatic
disease; c) Has had major surgery (<3 weeks prior to first dose).

- Received radiation therapy to the lung that is > 30 Gy within 6 months of the first
dose of study drug.

- Completed palliative radiotherapy within 7 days of the first dose of study drug.

- Is expected to require any other form of antineoplastic therapy while on study.

- Has received a live-virus vaccination within 30 days of planned treatment start.

- Has a known history of prior 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.

- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.

- Has pre-existing peripheral neuropathy that is ≥ Grade 2 by Common Terminology
Criteria for Adverse Events (CTCAE) version 4 criteria.

- Previously had a severe hypersensitivity reaction to treatment with another monoclonal
antibody.

- Has a known sensitivity to any component of carboplatin or paclitaxel or
nab-paclitaxel.

- Has active autoimmune disease that has required systemic treatment in past 2 years.

- Is on chronic systemic steroids.

- Had prior treatment with any other anti-programmed cell death 1 (anti-PD-1), or
programmed cell death ligand 1 (PD-L1) or PD-L2 agent or an antibody or a small
molecule targeting other immuno-regulatory receptors or mechanisms.

- Has participated in any other pembrolizumab trial and has been treated with
pembrolizumab.

- Has an active infection requiring therapy.

- Has known history of Human Immunodeficiency Virus (HIV).

- Has known active Hepatitis B or C. Active Hepatitis B.

- Is, at the time of signing informed consent, a regular user (including "recreational
use") of any illicit drugs or has a recent history (within the last year) of substance
abuse (including alcohol).

- Has interstitial lung disease or a history of pneumonitis that required oral or
intravenous glucocorticoids to assist with management.

- Is pregnant or breastfeeding, or expecting to conceive or father children while on
study drug and for the required duration of contraception after the last dose of study
drug.
We found this trial at
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Denver, CO
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Cincinnati, OH
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North Ryde, 2113
Phone: 61 2 8988 8428
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North Ryde,
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Tyler, TX
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