NCT03771820

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

Status unknown Phase 2 Last updated 17 March 2021

What this trial tests

Phase 2 trial testing NC-6004 in SCCHN in 136 participants. Status unknown.

Timeline

1 July 2019

Primary endpoint
30 April 2021

30 April 2022

Quick facts

Lead sponsor	NanoCarrier Co., Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	136
Start date	1 July 2019
Primary completion	30 April 2021
Estimated completion	30 April 2022
Sites	24 locations across Russia, Ukraine, Serbia, Taiwan, Poland, Hungary, Croatia, Czechia

Drugs / interventions tested

• NC-6004 — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• SCCHN — all drugs for SCCHN →

Sponsor

NanoCarrier Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with SCCHN. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanoparticles in the clinic: An update.
   Anselmo AC, Mitragotri S. · · 2019 · cited 976× · PMID 31572799 · DOI 10.1002/btm2.10143
2. Polymeric Nanoparticles for Drug Delivery.
   Beach MA, Nayanathara U, Gao Y, Zhang C, et al · · 2024 · cited 476× · PMID 38626459 · DOI 10.1021/acs.chemrev.3c00705
3. Metallodrugs are unique: opportunities and challenges of discovery and development.
   Anthony EJ, Bolitho EM, Bridgewater HE, Carter OWL, et al · · 2020 · cited 372× · PMID 34123239 · DOI 10.1039/d0sc04082g
4. Nanoparticles in the clinic: An update post COVID-19 vaccines.
   Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
5. Cancer nanotechnology: current status and perspectives.
   Kemp JA, Kwon YJ. · · 2021 · cited 117× · PMID 34727233 · DOI 10.1186/s40580-021-00282-7
6. Nanocarriers for the Delivery of Medical, Veterinary, and Agricultural Active Ingredients.
   Chariou PL, Ortega-Rivera OA, Steinmetz NF. · · 2020 · cited 101× · PMID 32125825 · DOI 10.1021/acsnano.0c00173
7. Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
   Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
8. Advances in nanomaterials for the diagnosis and treatment of head and neck cancers: A review.
   Yu C, Li L, Wang S, Xu Y, et al · · 2023 · cited 19× · PMID 37056270 · DOI 10.1016/j.bioactmat.2022.08.010