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

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.

Study Overview

• Status: Recruiting
• Conditions: SCCHN
• Intervention / Treatment: Drug: NC-6004; Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Atsushi Osada; Phone Number: 781 219 4958; Email: osada@nanocarrier.co.jp

Study Locations

• Croatia
  • Osijek, Croatia
    • Recruiting
    • 0603
  • Zagreb, Croatia
    • Recruiting
    • 0601
  • Zagreb, Croatia
    • Recruiting
    • 0602
• Czechia
  • Brno, Czechia
    • Recruiting
    • 0701
  • Hradec Králové, Czechia
    • Recruiting
    • 0702
  • Olomouc, Czechia
    • Recruiting
    • 0703
• Hungary
  • Budapest, Hungary
    • Recruiting
    • 0104
  • Debrecen, Hungary
    • Recruiting
    • 0105
  • Kecskemét, Hungary
    • Recruiting
    • 0103
  • Pécs, Hungary
    • Recruiting
    • 0101
• Poland
  • Bydgoszcz, Poland
    • Recruiting
    • 0202
  • Łódź, Poland
    • Recruiting
    • 0201
• Russian Federation
  • Ekaterinburg, Russian Federation
    • Recruiting
    • 0801
  • Omsk, Russian Federation
    • Recruiting
    • 0802
• Serbia
  • Belgrade, Serbia
    • Recruiting
    • 0301
  • Niš, Serbia
    • Recruiting
    • 0303
  • Sremska Kamenica, Serbia
    • Recruiting
    • 0301
• Taiwan
  • Taichung City, Taiwan
    • Recruiting
    • 0404
  • Taipei city, Taiwan
    • Recruiting
    • 0402
  • Taipei city, Taiwan
    • Recruiting
    • 0403
  • Taoyuan City, Taiwan
    • Recruiting
    • 0401
• Ukraine
  • Cherkasy, Ukraine
    • Recruiting
    • 0902
  • Ivano-Frankivs'k, Ukraine
    • Recruiting
    • 0903
  • Kharkiv, Ukraine
    • Recruiting
    • 0904

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be willing and able to provide written informed consent for the trial.
• Males or females aged ≥18 years at screening.
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Have histologically- or cytologically-confirmed HNSCC.
• Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies.
• Having prior platinum failure.

Exclusion Criteria:

• Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, nonsquamous histologies.
• Have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent.
• Have no more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in Part 1 of the study and from randomization in to Part 2.
• Are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment.
• Were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NC-6004 +pembrolizumab; 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. In phase IIa portion, NC-6004 dose goes up from 90 mg/m2 up to 135 mg/m2. In phase IIb portion, the dose should be the determined RPII dose in phase IIa portion.	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.; Other Names: Nanoplatin; Drug: Pembrolizumab; The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.; Other Names: Keytruda
Active Comparator: Pembrolizumab; The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.	Drug: Pembrolizumab; The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.; Other Names: Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the Recommended Phase (RPII) dose (mg/m2) of NC-6004 in combination with pembrolizumab	In PIIa portion, to determine RPII dose of NC-6004 in combination with pembrolizumab	1 year
Compare median Progression Free Survival (PFS) between NC-6004 +pembrolizumab and pembrolizumab alone	In PIIb portion, to compare PFS between NC-6004 plus pembrolizumab and pembrolizumab alone.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare median Overall Survival (OS) between NC-6004 +pembrolizumab and pembrolizumab alone	In PIIb portion, to compare OS rate between NC-6004 plus pembrolizumab and pembrolizumab alone.	2 years
Compare overall response (complete response and partial response) rate between NC-6004 +pembrolizumab and pembrolizumab alone	In PIIb portion, to ORR between NC-6004 plus pembrolizumab and pembrolizumab alone	1 year
Compare duration of response between NC-6004 +pembrolizumab and pembrolizumab alone	In PIIb portion, to compare DOR between NC-6004 plus pembrolizumab and pembrolizumab alone	1 year
Compare time to response between NC-6004 +pembrolizumab and pembrolizumab alone	In PIIb portion, to compare TTR between NC-6004 plus pembrolizumab and pembrolizumab alone	1 year
Safety and tolerability as measured by severity of Adverse Events (AEs)	The safety endpoints for this study are the incidence and severity of AEs in accordance with the NCI CTCAE and the occurrence of SAEs and treatment discontinuations due to AEs	1 year
Assess the Maximum Plasma Concentration (Cmax) of NC-6004 in combination with pembrolizumab	Assess PK parameters of the Maximum Plasma Concentration (Cmax)	1 year
Assess the Time to Maximum Concentration (Tmax) of NC-6004 in combination with pembrolizumab	Assess PK parameters of Time to Maximum Concentration (Tmax)	1 year
Assess the Area Under the Concentration (AUC) of NC-6004 in combination with pembrolizumab	Assess PK parameters of Area Under the Concentration (AUC)	1 year
Assess the Half-life(T½) of NC-6004 in combination with pembrolizumab	Assess PK parameters of Half-life(T½)	1 year
Assess the Clearance (CL) of NC-6004 in combination with pembrolizumab	Assess PK parameters of Clearance (CL)	1 year
Assess the Volume of Distribution (V) of NC-6004 in combination with pembrolizumab	Assess PK parameters of Volume of Distribution (V)	1 year

Collaborators and Investigators

• Sponsor: NanoCarrier Co., Ltd.
• Collaborators: Orient Europharma Co., Ltd.
• Investigators: Study Director: Atsushi Osada, NanoCarrier US LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: December 9, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Pembrolizumab
• Other Study ID Numbers: NC-6004-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No