A Phase II Trial to Investigate Genetic Markers of Response to Pembrolizumab (MK-3475, SCH 900475) Combined with Chemotherapy as a First-line Treatment for Non-Small Cell Lung Cancer (KEYNOTE-782) - Biomarkers of Response to Pembrolizumab Combined with Chemotherapy in Non-Small Cell Lung Cancer

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites100 target enrollmentAugust 14, 2018

DrugsKEYTRUDA (pembrolizumab, MK-3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 100
Status: Active, Not Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 14, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Have a histologically\-confirmed or cytologically confirmed diagnosis of stage IV (M1a, M1b, or M1c \[AJCC 8th edition]) nonsquamous NSCLC
•2\. Have confirmation that EGFR\-, B\-RAF\-, ROS1\-, or ALK\-directed therapy is not indicated (documentation of absence of tumor\-activating EGFR or B\-RAF mutations, AND absence of ALK or ROS1 gene rearrangements OR presence of a KRAS mutation)
•3\. Have measurable disease based on RECIST 1\.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
•4\. Have not received prior systemic treatment for their advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease
•5\. Have provided an evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (that was not previously irradiated) for biomarker analysis (Fine Needle Aspiration \[FNA] samples will not be accepted). Formalin\-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
•6\. Participant is \=18 years of age inclusive, at the time of signing the informed consent
•7\. Have an ECOG performance status of 0 or 1 within 10 days prior to the first dose of study treatment
•8\. Male participants agree to use a contraception during the treatment period and for at least 120 days, corresponding to time needed to eliminate any study intervention(s) (pembrolizumab and/or any active comparator/combination) plus an additional 90 days (a spermatogenesis cycle) for study interventions where there is risk of clinically relevant genotoxicity after the last dose of study intervention and refrain from donating sperm during this period
•9\. Female participants not be pregnant or breastfeeding, and at least 1 of the following conditions applies:
•a. Not be a woman of childbearing potential (WOCBP)

Exclusion Criteria

•1\. Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type
•2\. Has small cell elements present in NSCLC tumor
•3\. Is a WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
•4\. Has clinically active diverticulitis, intra\-abdominal abscess, GI obstruction, peritoneal carcinomatosis
•5\. Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy
•6\. Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco\- or paracentesis) is eligible
•7\. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study intervention
•8\. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation\-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1\-week washout is permitted for palliative radiation (\=2 weeks of radiotherapy) to non\-CNS disease
•9\. Has received prior therapy with a PD\-1/PD\-L1 receptor inhibitor
•10\. Is expected to require any other form of antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection)