Clinical trial NCT03771820: Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: SCCHN
Lead sponsor: NanoCarrier Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Orient Europharma Co., Ltd.
First posted: 2018-12-11
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the Recommended Phase (RPII) dose (mg/m2) of NC-6004 in combination with pembrolizumab
timeFrame: 1 year
measure: Compare median Progression Free Survival (PFS) between NC-6004 +pembrolizumab and pembrolizumab alone
timeFrame: 1 year
Secondary outcomes:
measure: Compare median Overall Survival (OS) between NC-6004 +pembrolizumab and pembrolizumab alone
timeFrame: 2 years
measure: Compare overall response (complete response and partial response) rate between NC-6004 +pembrolizumab and pembrolizumab alone
timeFrame: 1 year
measure: Compare duration of response between NC-6004 +pembrolizumab and pembrolizumab alone
timeFrame: 1 year
measure: Compare time to response between NC-6004 +pembrolizumab and pembrolizumab alone
timeFrame: 1 year
measure: Safety and tolerability as measured by severity of Adverse Events (AEs)
timeFrame: 1 year
measure: Assess the Maximum Plasma Concentration (Cmax) of NC-6004 in combination with pembrolizumab
timeFrame: 1 year
measure: Assess the Time to Maximum Concentration (Tmax) of NC-6004 in combination with pembrolizumab
timeFrame: 1 year
measure: Assess the Area Under the Concentration (AUC) of NC-6004 in combination with pembrolizumab
timeFrame: 1 year
measure: Assess the Half-life(T½) of NC-6004 in combination with pembrolizumab
timeFrame: 1 year
measure: Assess the Clearance (CL) of NC-6004 in combination with pembrolizumab
timeFrame: 1 year
measure: Assess the Volume of Distribution (V) of NC-6004 in combination with pembrolizumab
timeFrame: 1 year
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: 0603
city: Zagreb
country: Croatia
facility: 0601
city: Zagreb
country: Croatia
facility: 0602
city: Brno
country: Czechia
facility: 0701
city: Hradec Králové
country: Czechia
facility: 0702
city: Olomouc
country: Czechia
facility: 0703
city: Budapest
country: Hungary
facility: 0104
city: Debrecen
country: Hungary
facility: 0105
city: Kecskemét
country: Hungary
facility: 0103
city: Pécs
country: Hungary
facility: 0101
city: Bydgoszcz
country: Poland
facility: 0202
city: Łódź
country: Poland
facility: 0201
city: Ekaterinburg
country: Russian Federation
facility: 0801
city: Omsk
country: Russian Federation
facility: 0802
city: Belgrade
country: Serbia
facility: 0301
city: Niš
country: Serbia
facility: 0303
city: Sremska Kamenica
country: Serbia
facility: 0301
city: Taichung City
country: Taiwan
facility: 0404
city: Taipei city
country: Taiwan
facility: 0402
city: Taipei city
country: Taiwan
facility: 0403
city: Taoyuan City
country: Taiwan
facility: 0401
city: Cherkasy
country: Ukraine
facility: 0902
city: Ivano-Frankivs'k
country: Ukraine
facility: 0903
city: Kharkiv
country: Ukraine
facility: 0904
Study officials:
affiliation: NanoCarrier US LLC
name: Atsushi Osada
role: STUDY_DIRECTOR
References: