Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

2645 - Pembrolizumab and nanoparticle albumin bound paclitaxel (nab-paclitaxel) for metastatic urothelial carcinoma (UC) after chemotherapy failure: the open-label, single-arm, phase 2 PEANUT study

Date

10 Sep 2017

Session

Poster display session

Presenters

Andrea Necchi

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

A. Necchi1, L. Mariani2, A. Anichini3, P. Giannatempo1, D. Raggi1, G. Calareso4, R. Salvioni5

Author affiliations

  • 1 Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2 Clinical Epidemiologi And Trials Organization Unit, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 3 Immunotherapy Unit, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano/IT
  • 4 Radiology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano/IT
  • 5 Urology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano/IT
More

Resources

Abstract 2645

Background

Pembrolizumab (pembro) is a new standard of care in chemotherapy (CT) pre-treated UC patients (pts) and nab-paclitaxel (nPtx) has shown one of the highest activities among CT options in UC. Their combination may overcome resistance to immunotherapy (IT) and result in longer delay in the time to disease progression (PD). We will explore dynamic biomarkers of response to CT+IT.

Trial design

In an open-label, single-arm, single-center, phase 2 trial, pts receive pembro 200 mg intravenously (IV) on D1 and nPtx at the dose of 125 mg/m2 IV on D1 and D8. Cycles are repeated every 3 weeks until PD or onset of unacceptable toxicity. Key inclusion criteria are: predominant UC, failure of ≤ 2 platinum-based CT for metastatic disease (2nd-to-3rd line only). Neoadjuvant/adjuvant CT is counted if relapse occurred ≤6 months of the last CT cycle. Response is evaluated by RECIST criteria v.1.1 every 2 cycles. PD-L1 expression will be assessed at the study conclusion on both immune cells (IC) and tumor cells at a centralized laboratory (Qualtek, Goleta, CA, USA). The primary endpoint of the study is the progression-free survival (PFS). The target is to detect an improvement in the median PFS from ≤3.0 months (H0) to ≥ 5.0 months (H1). To achieve 90% power with a one-sided non-parametric test at the 10% significance level, we estimated that 64 pts must be accrued over 18 months, with follow-up duration of 12 months. PFS will be also analyzed according to the PD-L1 expression. Should the above investigation suggest that the treatment benefit is stronger in PD-L1+ pts, there is the option to expand this cohort up to a maximum of 50 pts. As such, we estimate 85.1% power to detect the target improvement in PFS. The decision of cohort expansion will rely on predictive power (PP) calculation: a PP ≥ 30% will be regarded as promising. Translational analyses will include multiparametric flow cytometry of blood samples, gene expression (RNA-seq, Illumina HiSeq) and mutation profiling of tumor samples (Ion Torrent Personal Genome Machine). These profiles will be matched with response to treatment and PFS/overall survival (EudraCT number 2017-000579-10).

Clinical trial identification

EudraCT number 2017-000579-10

Legal entity responsible for the study

Fondazione IRCCS Istituto Nazionale dei Tumori

Funding

Merck

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.