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

SCCHN Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03771820
• Other study ID #: NC-6004-009
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: March 2021
• Source: NanoCarrier Co., Ltd.
• Contact: Atsushi Osada
• Phone: 781 219 4958
• Email: osada[@]nanocarrier.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• SCCHN

Intervention

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.
• Pembrolizumab
The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
NanoCarrier Co., Ltd.	Orient Europharma Co., Ltd.

Countries where clinical trial is conducted

Croatia,  Czechia,  Hungary,  Poland,  Russian Federation,  Serbia,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assess the Maximum Plasma Concentration (Cmax) of NC-6004 in combination with pembrolizumab	Assess PK parameters of the Maximum Plasma Concentration (Cmax)	1 year
Secondary	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
Secondary	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
Secondary	Assess the Half-life(T½) of NC-6004 in combination with pembrolizumab	Assess PK parameters of Half-life(T½)	1 year
Secondary	Assess the Clearance (CL) of NC-6004 in combination with pembrolizumab	Assess PK parameters of Clearance (CL)	1 year
Secondary	Assess the Volume of Distribution (V) of NC-6004 in combination with pembrolizumab	Assess PK parameters of Volume of Distribution (V)	1 year