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

NCT03771820 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2021-03-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Orient Europharma Co., Ltd.

    collaborator INDUSTRY

  • NanoCarrier Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Atsushi Osada · NanoCarrier US LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2021-04-30
Completion
2022-04-30
FDA Drug
Yes

Countries

  • Croatia
  • Czechia
  • Hungary
  • Poland
  • Russia
  • Serbia
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03771820 on ClinicalTrials.gov