drugset / Trial / NCT03771820

Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen

NCT03771820 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

In Phase IIa, dose-escalation study to determine the optimum tolerated dose and a recommended Phase IIb (RPIIb) dose in combination with pembrolizumab in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck who have failed platinum or a platinum containing regimen. In Phase IIb, randomized control study between NC-6004 in combination with pembrolizumab versus pembrolizumab alone in the same subject population as Part 1 at the RPIIb dose identified in PIIa.

Timeline

Start
2019-07-01
Primary completion
2021-04-30
Completion
2022-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject NC-6004 Other / unclassified 90 mg/m2 —
Subject NC-6004 Other / unclassified 135 mg/m2 —
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous