SCCHNPhase 2NCT03771820
Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen
A Phase 2 study testing NC-6004 and Pembrolizumab in people with SCCHN, run by NanoCarrier Co., Ltd. at 24 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCCHN
- What is being tested?
- NC-6004 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 24 sitesin 8 countries
- Study dates
- 1 Jul 2019to 30 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
Hungary4 sites, 4 recruiting
- Recruiting
0104
Budapest
- Recruiting
0105
Debrecen
- Recruiting
0103
Kecskemét
- Recruiting
0101
Pécs
Taiwan4 sites, 4 recruiting
- Recruiting
0404
Taichung
- Recruiting
0402
Taipei
- Recruiting
0403
Taipei
- Recruiting
0401
Taoyuan City
Croatia3 sites, 3 recruiting
- Recruiting
0603
Osijek
- Recruiting
0601
Zagreb
- Recruiting
0602
Zagreb
Czechia3 sites, 3 recruiting
- Recruiting
0701
Brno
- Recruiting
0702
Hradec Králové
- Recruiting
0703
Olomouc
Serbia3 sites, 3 recruiting
- Recruiting
0301
Belgrade
- Recruiting
0301
Kamenitz
- Recruiting
0303
Niš
Ukraine3 sites, 3 recruiting
- Recruiting
0902
Cherkasy
- Recruiting
0903
Ivano-Frankivsk
- Recruiting
0904
Kharkiv
About this study
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
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.
- Conditions
- SCCHN
- Being tested
- NC-6004, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC-6004Drug
Also called Nanoplatin
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.
PembrolizumabDrug
Also called Keytruda
The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NC-6004 +pembrolizumab | Experimental | 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. Receives: Drug: NC-6004; Drug: Pembrolizumab |
| Pembrolizumab | Active comparator | The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
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.
Measured: 1 year
Secondary outcomes (11)
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.
Measured: 2 years
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Assess the Maximum Plasma Concentration (Cmax) of NC-6004 in combination with pembrolizumab
Assess PK parameters of the Maximum Plasma Concentration (Cmax)
Measured: 1 year
Assess the Time to Maximum Concentration (Tmax) of NC-6004 in combination with pembrolizumab
Assess PK parameters of Time to Maximum Concentration (Tmax)
Measured: 1 year
Assess the Area Under the Concentration (AUC) of NC-6004 in combination with pembrolizumab
Assess PK parameters of Area Under the Concentration (AUC)
Measured: 1 year
Assess the Half-life(T½) of NC-6004 in combination with pembrolizumab
Assess PK parameters of Half-life(T½)
Measured: 1 year
Assess the Clearance (CL) of NC-6004 in combination with pembrolizumab
Assess PK parameters of Clearance (CL)
Measured: 1 year
Assess the Volume of Distribution (V) of NC-6004 in combination with pembrolizumab
Assess PK parameters of Volume of Distribution (V)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Jul 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCCHNStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NanoCarrier Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orient Europharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Atsushi Osada, Study director, NanoCarrier US LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771820
- Sponsor's protocol ID
- NC-6004-009
- Status last verified
- Mar 2021
- First submitted
- 1 Nov 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03771820
- Acronym / sponsor ID
- NC-6004-009
- Conditions
- SCCHN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- NanoCarrier Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Orient Europharma Co., Ltd.
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NC-6004 +pembrolizumab | Experimental | Drug: NC-6004, Drug: PembrolizumabNC-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. |
| Pembrolizumab | Active comparator | Drug: PembrolizumabThe recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NC-6004Also: NanoplatinNC-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. | Drug | NC-6004 +pembrolizumab |
| PembrolizumabAlso: KeytrudaThe recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks. | Drug | NC-6004 +pembrolizumab, Pembrolizumab |
Primary outcome
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
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.
11 secondary outcomes
Compare median Overall Survival (OS) between NC-6004 +pembrolizumab and pembrolizumab alone
Time frame: 2 years
Compare overall response (complete response and partial response) rate between NC-6004 +pembrolizumab and pembrolizumab alone
Time frame: 1 year
Compare duration of response between NC-6004 +pembrolizumab and pembrolizumab alone
Time frame: 1 year
Compare time to response between NC-6004 +pembrolizumab and pembrolizumab alone
Time frame: 1 year
Safety and tolerability as measured by severity of Adverse Events (AEs)
Time frame: 1 year
Assess the Maximum Plasma Concentration (Cmax) of NC-6004 in combination with pembrolizumab
Time frame: 1 year
Assess the Time to Maximum Concentration (Tmax) of NC-6004 in combination with pembrolizumab
Time frame: 1 year
Assess the Area Under the Concentration (AUC) of NC-6004 in combination with pembrolizumab
Time frame: 1 year
Assess the Half-life(T½) of NC-6004 in combination with pembrolizumab
Time frame: 1 year
Assess the Clearance (CL) of NC-6004 in combination with pembrolizumab
Time frame: 1 year
Assess the Volume of Distribution (V) of NC-6004 in combination with pembrolizumab
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atsushi Osada study director
NanoCarrier US LLC
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NC-6004 and Pembrolizumab in people with SCCHN, run by NanoCarrier Co., Ltd. at 24 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Hungary, Taiwan, Croatia, Czechia, Serbia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atsushi Osada (781 219 4958, osada@nanocarrier.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Recommended Phase (RPII) dose (mg/m2) of NC-6004 in combination with pembrolizumab (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.