drugset / Trial / NCT03771820
Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NC-6004 | Other / unclassified | 90 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | 135 mg/m2 | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |