Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen
NCT ID: NCT03771820
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
136 participants
INTERVENTIONAL
2019-07-01
2022-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Pembrolizumab
The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.
Pembrolizumab
The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Orient Europharma Co., Ltd.
INDUSTRY
NanoCarrier Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Atsushi Osada
Role: STUDY_DIRECTOR
NanoCarrier US LLC
Locations
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0603
Osijek, , Croatia
0601
Zagreb, , Croatia
0602
Zagreb, , Croatia
0701
Brno, , Czechia
0702
Hradec Králové, , Czechia
0703
Olomouc, , Czechia
0104
Budapest, , Hungary
0105
Debrecen, , Hungary
0103
Kecskemét, , Hungary
0101
Pécs, , Hungary
0202
Bydgoszcz, , Poland
0201
Lodz, , Poland
0802
Omsk, , Russia
0801
Yekaterinburg, , Russia
0301
Belgrade, , Serbia
0301
Kamenitz, , Serbia
0303
Niš, , Serbia
0404
Taichung, , Taiwan
0402
Taipei, , Taiwan
0403
Taipei, , Taiwan
0401
Taoyuan, , Taiwan
0902
Cherkasy, , Ukraine
0903
Ivano-Frankivsk, , Ukraine
0904
Kharkiv, , Ukraine
Countries
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Central Contacts
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Other Identifiers
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NC-6004-009
Identifier Type: -
Identifier Source: org_study_id
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