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

NCT03771820 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: NC-6004-009
• Study Type: interventional
• Target: 136
• Locations: 8 countries
• Sites: 24

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.

Conditions

SCCHN

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  1 year

Secondary Outcomes (11)

• Compare median Overall Survival (OS) between NC-6004 +pembrolizumab and pembrolizumab alone

  2 years

• Compare overall response (complete response and partial response) rate between NC-6004 +pembrolizumab and pembrolizumab alone

  1 year

• Compare duration of response between NC-6004 +pembrolizumab and pembrolizumab alone

  1 year

• Compare time to response between NC-6004 +pembrolizumab and pembrolizumab alone

  1 year

• Safety and tolerability as measured by severity of Adverse Events (AEs)

  1 year

Study Arms (2)

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.

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.

Drug: Pembrolizumab

Interventions

NC-6004 DRUG

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.

Also known as: Nanoplatin

NC-6004 +pembrolizumab

Pembrolizumab DRUG

The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.

Also known as: Keytruda

NC-6004 +pembrolizumab; Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NanoCarrier Co., Ltd.: lead
• Orient Europharma Co., Ltd.: collaborator

Study Sites (24)

0603

Osijek, Croatia

RECRUITING

0601

Zagreb, Croatia

RECRUITING

0602

Zagreb, Croatia

RECRUITING

0701

Brno, Czechia

RECRUITING

0702

Hradec Králové, Czechia

RECRUITING

0703

Olomouc, Czechia

RECRUITING

0104

Budapest, Hungary

RECRUITING

0105

Debrecen, Hungary

RECRUITING

0103

Kecskemét, Hungary

RECRUITING

0101

Pécs, Hungary

RECRUITING

0202

Bydgoszcz, Poland

RECRUITING

0201

Lodz, Poland

RECRUITING

0802

Omsk, Russia

RECRUITING

0801

Yekaterinburg, Russia

RECRUITING

0301

Belgrade, Serbia

RECRUITING

0301

Kamenitz, Serbia

RECRUITING

0303

Niš, Serbia

RECRUITING

0404

Taichung, Taiwan

RECRUITING

0402

Taipei, Taiwan

RECRUITING

0403

Taipei, Taiwan

RECRUITING

0401

Taoyuan, Taiwan

RECRUITING

0902

Cherkasy, Ukraine

RECRUITING

0903

Ivano-Frankivsk, Ukraine

RECRUITING

0904

Kharkiv, Ukraine

RECRUITING

MeSH Terms

Interventions

demplatin pegraglumer; pembrolizumab

Study Officials

• Atsushi Osada

  NanoCarrier US LLC

  STUDY DIRECTOR

Central Study Contacts

Atsushi Osada

CONTACT

781 219 4958; osada@nanocarrier.co.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: December 11, 2018
• Study Start: July 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

PL (2); SE (3); TW (4); CZ (3); HU (4); RU (2); CR (3); UA (3)