Clinical Trials /

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

NCT03771820

Description:

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.

Related Conditions:
  • Hypopharyngeal Carcinoma
  • Laryngeal Carcinoma
  • Oral Cavity Carcinoma
  • Oropharyngeal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: NC-6004-009
  • NCT ID: NCT03771820

Conditions

  • SCCHN

Interventions

DrugSynonymsArms
NC-6004NanoplatinNC-6004 +pembrolizumab
PembrolizumabKeytrudaNC-6004 +pembrolizumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
NC-6004 +pembrolizumabExperimentalNC-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.
  • NC-6004
  • Pembrolizumab
PembrolizumabActive ComparatorThe recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.
  • Pembrolizumab

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine the Recommended Phase (RPII) dose (mg/m2) of NC-6004 in combination with pembrolizumab
Time Frame:1 year
Safety Issue:
Description:In PIIa portion, to determine RPII dose of NC-6004 in combination with pembrolizumab

Secondary Outcome Measures

Measure:Compare median Overall Survival (OS) between NC-6004 +pembrolizumab and pembrolizumab alone
Time Frame:2 years
Safety Issue:
Description:In PIIb portion, to compare OS rate between NC-6004 plus pembrolizumab and pembrolizumab alone.
Measure:Compare overall response (complete response and partial response) rate between NC-6004 +pembrolizumab and pembrolizumab alone
Time Frame:1 year
Safety Issue:
Description:In PIIb portion, to ORR between NC-6004 plus pembrolizumab and pembrolizumab alone
Measure:Compare duration of response between NC-6004 +pembrolizumab and pembrolizumab alone
Time Frame:1 year
Safety Issue:
Description:In PIIb portion, to compare DOR between NC-6004 plus pembrolizumab and pembrolizumab alone
Measure:Compare time to response between NC-6004 +pembrolizumab and pembrolizumab alone
Time Frame:1 year
Safety Issue:
Description:In PIIb portion, to compare TTR between NC-6004 plus pembrolizumab and pembrolizumab alone
Measure:Safety and tolerability as measured by severity of Adverse Events (AEs)
Time Frame:1 year
Safety Issue:
Description: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
Measure:Assess the Maximum Plasma Concentration (Cmax) of NC-6004 in combination with pembrolizumab
Time Frame:1 year
Safety Issue:
Description:Assess PK parameters of the Maximum Plasma Concentration (Cmax)
Measure:Assess the Time to Maximum Concentration (Tmax) of NC-6004 in combination with pembrolizumab
Time Frame:1 year
Safety Issue:
Description:Assess PK parameters of Time to Maximum Concentration (Tmax)
Measure:Assess the Area Under the Concentration (AUC) of NC-6004 in combination with pembrolizumab
Time Frame:1 year
Safety Issue:
Description:Assess PK parameters of Area Under the Concentration (AUC)
Measure:Assess the Half-life(T½) of NC-6004 in combination with pembrolizumab
Time Frame:1 year
Safety Issue:
Description:Assess PK parameters of Half-life(T½)
Measure:Assess the Clearance (CL) of NC-6004 in combination with pembrolizumab
Time Frame:1 year
Safety Issue:
Description:Assess PK parameters of Clearance (CL)
Measure:Assess the Volume of Distribution (V) of NC-6004 in combination with pembrolizumab
Time Frame:1 year
Safety Issue:
Description:Assess PK parameters of Volume of Distribution (V)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NanoCarrier Co., Ltd.

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