Trial Purpose

This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combination with pembrolizumab (Arm C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab (Arms A-F); evaluate the safety and tolerability of MK-4830 administered in combination with pembrolizumab, carboplatin, and pemetrexed (Arm G) and of MK-4830 administered in combination with pembrolizumab and lenvatinib (Arm H); evaluate the safety, tolerability and ORR of MK-4830 in combination with pembrolizumab plus chemotherapy (Arms I-L); and evaluate the safety and tolerability of MK-4830 in combination with pembrolizumab in Chinese participants from China (Arm M). The coformulation part (Arm N) evaluates the safety and tolerability of MK-4830A (coformulation of MK-4830 800 mg + pembrolizumab 200 mg). There is no formal hypothesis testing in this study.

Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03564691

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About The Study

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Phase 1

Tests the medicine or vaccine in a small group of 20 to 100 volunteers who are usually healthy, but not always. The trial often takes place in a hospital.

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Dates

  • Actual study start date 11 July 2018
  • Estimated primary completion date 4 November 2025
  • Estimated study completion date 4 November 2025

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

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Conditions

Neoplasms

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.