NCT03380871

A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer

Completed Phase 1 Last updated 26 February 2021

What this trial tests

Phase 1 trial testing NEO-PV-01 in Carcinoma, Non-Small-Cell Lung in 38 participants. Completed in 5 February 2021.

Timeline

4 May 2018

Primary endpoint
31 October 2019

5 February 2021

Quick facts

Lead sponsor	BioNTech US Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	4 May 2018
Primary completion	31 October 2019
Estimated completion	5 February 2021
Sites	5 locations across United States

Drugs / interventions tested

• NEO-PV-01
• Pembrolizumab (pembrolizumab) — full drug profile →
• Adjuvant — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Pemetrexed — full drug profile →

Conditions studied

• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →
• Lung Cancer — all drugs for Lung Cancer →
• Nonsquamous Nonsmall Cell Neoplasm of Lung — all drugs for Nonsquamous Nonsmall Cell Neoplasm of Lung →

Sponsor

BioNTech US Inc. — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab and chemotherapy treatment alone. All eligible patients will receive NEO-PV-01 + Adjuvant, pembrolizumab and chemotherapy while on this trial.

Publications & conference data

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

1. Neoantigens: promising targets for cancer therapy.
   Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x
2. Therapeutic cancer vaccines: advancements, challenges, and prospects.
   Fan T, Zhang M, Yang J, Zhu Z, et al · · 2023 · cited 314× · PMID 38086815 · DOI 10.1038/s41392-023-01674-3
3. Emerging therapeutic agents for advanced non-small cell lung cancer.
   Chen R, Manochakian R, James L, Azzouqa AG, et al · · 2020 · cited 244× · PMID 32448366 · DOI 10.1186/s13045-020-00881-7
4. Personalized Cancer Vaccines: Clinical Landscape, Challenges, and Opportunities.
   Shemesh CS, Hsu JC, Hosseini I, Shen BQ, et al · · 2021 · cited 187× · PMID 33038322 · DOI 10.1016/j.ymthe.2020.09.038
5. Trial Watch: Toll-like receptor agonists in cancer immunotherapy.
   Smith M, García-Martínez E, Pitter MR, Fucikova J, et al · · 2018 · cited 171× · PMID 30524908 · DOI 10.1080/2162402x.2018.1526250
6. Neoantigen prediction and computational perspectives towards clinical benefit: recommendations from the ESMO Precision Medicine Working Group.
   De Mattos-Arruda L, Vazquez M, Finotello F, Lepore R, et al · · 2020 · cited 126× · PMID 32610166 · DOI 10.1016/j.annonc.2020.05.008
7. Trial watch: Peptide-based vaccines in anticancer therapy.
   Bezu L, Kepp O, Cerrato G, Pol J, et al · · 2018 · cited 114× · PMID 30524907 · DOI 10.1080/2162402x.2018.1511506
8. Toll-like receptor-guided therapeutic intervention of human cancers: molecular and immunological perspectives.
   Mukherjee S, Patra R, Behzadi P, Masotti A, et al · · 2023 · cited 102× · PMID 37822929 · DOI 10.3389/fimmu.2023.1244345