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Efficacy and Safety Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Adults With Selected Advanced/Metastatic Solid Tumors (MK-7123-034) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Adults With Selected Advanced/Metastatic Solid Tumors (MK-7123-034)

A Phase II Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Participants With Selected Advanced/Metastatic Solid Tumors

NCT03473925•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of navarixin (MK-7123) in combination with pembrolizumab (MK-3475) in adults with one of three types of solid tumors: Programmed Death-Ligand 1 (PD-L1) positive refractory non-small cell lung cancer (NSCLC), castration resistant prostate cancer (CRPC) or microsatellite stable (MSS) colorectal cancer (CRC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All Participants
•Has one of the following histologically- or cytologically-confirmed advanced/metastatic solid tumors: NSCLC, CRPC, or MSS CRC, by pathology report and has received, or been intolerant to, or has been ineligible for all treatment known to confer clinical benefit.
•Has Stage III or Stage IV disease that is not surgically resectable.
•Has measurable disease by RECIST 1.1 criteria as assessed by the local site investigator/radiology.
•Has supplied tumor tissue from either a newly obtained biopsy or an archival specimen for biomarker analysis.
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
•Female participants must agree to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
•Demonstrates adequate organ function.
•Non-small Cell Lung Cancer (NSCLC) Participants
+9 more criteria

Exclusion Criteria

•Has been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan.
•Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
•Has had a severe hypersensitivity reaction to treatment with any mAb or components of the study treatment(s).
•Has an active infection requiring systemic therapy.
•Has symptomatic ascites or pleural effusion.
•Has interstitial lung disease that required oral or intravenous glucocorticoids to assist with management.
•Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
•Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. Note: Participants who have had a stem cell transplant \>5 years ago are eligible as long as there are no symptoms of graft-versus-host disease (GVHD).
•Has a known history of human immunodeficiency virus (HIV) infection.
+12 more criteria

Locations (14)

Honor Health ( Site 0005)

Scottsdale, Arizona, United States

Florida Cancer Specialists ( Site 0003)

Sarasota, Florida, United States

University of Maryland ( Site 0008)

Baltimore, Maryland, United States

Henry Ford Health System ( Site 0006)

Detroit, Michigan, United States

Duke University Medical Center ( Site 0004)

Durham, North Carolina, United States

Blacktown Hospital Western Sydney Local Health District ( Site 0024)

Blacktown, New South Wales, Australia

Scientia Clinical Research ( Site 0021)

Randwick, New South Wales, Australia

Peter MacCallum Cancer Centre ( Site 0023)

Melbourne, Victoria, Australia

Princess Margaret Cancer Centre ( Site 0031)

Toronto, Ontario, Canada

Jewish General Hospital ( Site 0032)

Montreal, Quebec, Canada

Key Dates

Start Date

April 10, 2018

Primary Completion Date

May 19, 2021

Completion Date

May 19, 2021

Last Updated

August 28, 2024

Enrollment

107

ACTUAL participants

Conditions

Solid TumorsNon-small Cell Lung CancerCastration Resistant Prostate CancerMicrosatellite Stable Colorectal Cancer

Interventions

Navarixin

DRUG

Pembrolizumab

BIOLOGICAL

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Adults With Selected Advanced/Metastatic Solid Tumors (MK-7123-034)

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors