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A multicenter randomized phase II study of NPC-1C (N) in combination with gemcitabine (G) and nab-paclitaxel (A) versus G and A alone in patients with metastatic or locally advanced pancreatic cancer (PC) previously treated with folfirinox (F).

Publication ,  Conference
Duffy, AG; Beg, MS; Greten, TF; Beatson, MA; Mavroukakis, S; Patel, SP; Morse, MA; Arlen, PM
Published in: Journal of Clinical Oncology
January 20, 2015

TPS499 Background: PC carries a poor prognosis. F has improved overall survival (OS) compared to G leading to its use as a 1st line treatment for patients (pts) with advanced PC. Similarly, the combination of G and A has demonstrated OS benefit. No data exists for G/A in the 2nd line setting. Many oncologists continue to sequence F treatment followed upon disease progression by G/A for pts with advanced PC with good performance status. N is a chimeric monoclonal IgG1 antibody recognizing an aberrantly glycosylated MUC5AC specific to GI tumors. Its mechanism of action is through ADCC. An IHC based companion diagnostic assay is utilized to select pts whose tumors express the target (approx. 65-70%). A prior study administering N to pts with advanced PC refractory to chemotherapy was well tolerated with disease stabilization and prolongation of OS. Furthermore 2 of 5 pts receiving the combination of G+N following progression on F remain alive at 10 and 12 months respectively. Methods: The primary objective of this phase 2.5 study is to determine if the combination of N and G plus A can improve the OS for pts who have PC over G plus A alone in the post F setting. The trial is a 2-arm randomized 1:1 multi-institution trial of N plus G and A vs. G and A. Eligible pts would be expected to have an estimated 4.5 to 4.8 month median OS with G alone, but this may be enhanced somewhat with the addition of A. The goal is to determine if the use of N along with G and A will result in pts having an increased median OS of 8 months vs. an estimated 5 months without N. Kaplan-Meier curves and a two-tailed log-rank test will be the primary analysis methods. All pts must have tissue positive for the MUC5AC variant (≥20% by IHC). Because N has been established to be safe when given with G alone but not with the combination of G and A, stopping rules for safety will be adhered to for the first 6 pts randomized to G/A plus N. Enrollment to the study has commenced. Correlative studies will utilize both PBMCs and serum for immune monitoring. Frequency, phenotype and function of different immune cells (including CD8+ T cells, CD4+ T cells, Tregs and MDSCs) will be analyzed. Clinical trial information: NCT01834235.

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

January 20, 2015

Volume

33

Issue

3_suppl

Start / End Page

TPS499 / TPS499

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
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ICMJE
MLA
NLM
Duffy, A. G., Beg, M. S., Greten, T. F., Beatson, M. A., Mavroukakis, S., Patel, S. P., … Arlen, P. M. (2015). A multicenter randomized phase II study of NPC-1C (N) in combination with gemcitabine (G) and nab-paclitaxel (A) versus G and A alone in patients with metastatic or locally advanced pancreatic cancer (PC) previously treated with folfirinox (F). In Journal of Clinical Oncology (Vol. 33, pp. TPS499–TPS499). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2015.33.3_suppl.tps499
Duffy, Austin G., Muhammad Shaalan Beg, Tim F. Greten, Melony A. Beatson, Sharon Mavroukakis, Sandip Pravin Patel, Michael A. Morse, and Philip M. Arlen. “A multicenter randomized phase II study of NPC-1C (N) in combination with gemcitabine (G) and nab-paclitaxel (A) versus G and A alone in patients with metastatic or locally advanced pancreatic cancer (PC) previously treated with folfirinox (F).” In Journal of Clinical Oncology, 33:TPS499–TPS499. American Society of Clinical Oncology (ASCO), 2015. https://doi.org/10.1200/jco.2015.33.3_suppl.tps499.
Duffy AG, Beg MS, Greten TF, Beatson MA, Mavroukakis S, Patel SP, et al. A multicenter randomized phase II study of NPC-1C (N) in combination with gemcitabine (G) and nab-paclitaxel (A) versus G and A alone in patients with metastatic or locally advanced pancreatic cancer (PC) previously treated with folfirinox (F). In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2015. p. TPS499–TPS499.
Duffy, Austin G., et al. “A multicenter randomized phase II study of NPC-1C (N) in combination with gemcitabine (G) and nab-paclitaxel (A) versus G and A alone in patients with metastatic or locally advanced pancreatic cancer (PC) previously treated with folfirinox (F).Journal of Clinical Oncology, vol. 33, no. 3_suppl, American Society of Clinical Oncology (ASCO), 2015, pp. TPS499–TPS499. Crossref, doi:10.1200/jco.2015.33.3_suppl.tps499.
Duffy AG, Beg MS, Greten TF, Beatson MA, Mavroukakis S, Patel SP, Morse MA, Arlen PM. A multicenter randomized phase II study of NPC-1C (N) in combination with gemcitabine (G) and nab-paclitaxel (A) versus G and A alone in patients with metastatic or locally advanced pancreatic cancer (PC) previously treated with folfirinox (F). Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2015. p. TPS499–TPS499.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

January 20, 2015

Volume

33

Issue

3_suppl

Start / End Page

TPS499 / TPS499

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences