NCT03771820

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

Phase IIa/IIb Clinical Trial of NC-6004 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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: NanoCarrier Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SCCHN

Interventions

Type	Name	Description
DRUG	NC-6004	NC-6004 should be administered to subjects once every 3 weeks. On Day 1 of each treatment cycle NC-6004 will be administered first followed by pembrolizumab.
DRUG	Pembrolizumab	The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-04-30
• Completion: 2022-04-30
• First posted: 2018-12-11
• Last updated: 2021-03-17

Locations

24 sites across 8 countries: Croatia, Czechia, Hungary, Poland, Russia, Serbia, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study