A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumours (MK-0482-001)

Titre officiel

A Phase 1b, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0482 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumours.

Sommaire:

Il s’agit d’une étude à doses croissantes visant à déterminer l’innocuité et les paramètres pharmacocinétiques du MK-0482 administré seul et en association avec le pembrolizumab (MK-3475) chez des participants présentant des tumeurs solides avancées pour lesquelles il n’y a pas de traitement disponible pouvant apporter des bienfaits cliniques.

Description de l'essai

Primary Outcome:

• Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Part 1 only)
• Number of Participants Who Experience at Least One Adverse Event (AE)
• Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
• Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Part 2 only)

• Minimum Serum Concentration (Cmin) of MK-0482 When Administered as Monotherapy (Part 1 only)
• Cmin of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only)
• Maximum Serum Concentration (Cmax) of MK-0482 When Administered as Monotherapy (Part 1 only)
• Cmax of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only)
• Area Under the Concentration-Time Curve (AUC) of MK-0482 When Administered as Monotherapy (Part 1 only)
• AUC of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only)
• Objective Response Rate (ORR) As Assessed by Investigator per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) (Part 2 only)
• ORR As Assessed by Investigator per Response Assessment in Neuro-Oncology (RANO) (Part 2 only)

Voir cet essai sur ClinicalTrials.gov