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

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ClinicalTrials.gov Identifier: NCT03771820
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
NanoCarrier Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
SCCHN Drug: NC-6004 Drug: Pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


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 Name: Nanoplatin

Drug: Pembrolizumab
The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.
Other Name: 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 Name: Keytruda




Primary Outcome Measures :
  1. Determine the Recommended Phase (RPII) dose (mg/m2) of NC-6004 in combination with pembrolizumab [ Time Frame: 1 year ]
    In PIIa portion, to determine RPII dose of NC-6004 in combination with pembrolizumab

  2. Compare median Progression Free Survival (PFS) between NC-6004 +pembrolizumab and pembrolizumab alone [ Time Frame: 1 year ]
    In PIIb portion, to compare PFS between NC-6004 plus pembrolizumab and pembrolizumab alone.


Secondary Outcome Measures :
  1. Compare median Overall Survival (OS) between NC-6004 +pembrolizumab and pembrolizumab alone [ Time Frame: 2 years ]
    In PIIb portion, to compare OS rate between NC-6004 plus pembrolizumab and pembrolizumab alone.

  2. Compare overall response (complete response and partial response) rate between NC-6004 +pembrolizumab and pembrolizumab alone [ Time Frame: 1 year ]
    In PIIb portion, to ORR between NC-6004 plus pembrolizumab and pembrolizumab alone

  3. Compare duration of response between NC-6004 +pembrolizumab and pembrolizumab alone [ Time Frame: 1 year ]
    In PIIb portion, to compare DOR between NC-6004 plus pembrolizumab and pembrolizumab alone

  4. Compare time to response between NC-6004 +pembrolizumab and pembrolizumab alone [ Time Frame: 1 year ]
    In PIIb portion, to compare TTR between NC-6004 plus pembrolizumab and pembrolizumab alone

  5. Safety and tolerability as measured by severity of Adverse Events (AEs) [ Time Frame: 1 year ]
    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

  6. Assess the Maximum Plasma Concentration (Cmax) of NC-6004 in combination with pembrolizumab [ Time Frame: 1 year ]
    Assess PK parameters of the Maximum Plasma Concentration (Cmax)

  7. Assess the Time to Maximum Concentration (Tmax) of NC-6004 in combination with pembrolizumab [ Time Frame: 1 year ]
    Assess PK parameters of Time to Maximum Concentration (Tmax)

  8. Assess the Area Under the Concentration (AUC) of NC-6004 in combination with pembrolizumab [ Time Frame: 1 year ]
    Assess PK parameters of Area Under the Concentration (AUC)

  9. Assess the Half-life(T½) of NC-6004 in combination with pembrolizumab [ Time Frame: 1 year ]
    Assess PK parameters of Half-life(T½)

  10. Assess the Clearance (CL) of NC-6004 in combination with pembrolizumab [ Time Frame: 1 year ]
    Assess PK parameters of Clearance (CL)

  11. Assess the Volume of Distribution (V) of NC-6004 in combination with pembrolizumab [ Time Frame: 1 year ]
    Assess PK parameters of Volume of Distribution (V)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771820


Contacts
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Contact: Atsushi Osada +818037213752 osada@nanocarrier.co.jp

Locations
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United States, North Carolina
0101 Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
Serbia
0301 Recruiting
Belgrade, Serbia
0301 Recruiting
Sremska Kamenica, Serbia
Sponsors and Collaborators
NanoCarrier Co., Ltd.
Orient Europharma Co., Ltd.
Investigators
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Study Director: Atsushi Osada NanoCarrier US LLC

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Responsible Party: NanoCarrier Co., Ltd.
ClinicalTrials.gov Identifier: NCT03771820     History of Changes
Other Study ID Numbers: NC-6004-009
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pembrolizumab
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Antineoplastic Agents