Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R)

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Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R). / Chen, Inna M.; Donia, Marco; Chamberlain, Christopher A.; Jensen, Agnete W.P.; Draghi, Arianna; Theile, Susann; Madsen, Kasper; Hasselby, Jane P.; Toxværd, Anders; Høgdall, Estrid; Lorentzen, Torben; Wilken, Eva E.; Geertsen, Poul; Svane, Inge M.; Johansen, Julia S.; Nielsen, Dorte.

In: European Journal of Cancer, Vol. 180, 2023, p. 125-133.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Chen, IM, Donia, M, Chamberlain, CA, Jensen, AWP, Draghi, A, Theile, S, Madsen, K, Hasselby, JP, Toxværd, A, Høgdall, E, Lorentzen, T, Wilken, EE, Geertsen, P, Svane, IM, Johansen, JS & Nielsen, D 2023, 'Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R)', European Journal of Cancer, vol. 180, pp. 125-133. https://doi.org/10.1016/j.ejca.2022.11.035

APA

Chen, I. M., Donia, M., Chamberlain, C. A., Jensen, A. W. P., Draghi, A., Theile, S., Madsen, K., Hasselby, J. P., Toxværd, A., Høgdall, E., Lorentzen, T., Wilken, E. E., Geertsen, P., Svane, I. M., Johansen, J. S., & Nielsen, D. (2023). Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R). European Journal of Cancer, 180, 125-133. https://doi.org/10.1016/j.ejca.2022.11.035

Vancouver

Chen IM, Donia M, Chamberlain CA, Jensen AWP, Draghi A, Theile S et al. Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R). European Journal of Cancer. 2023;180:125-133. https://doi.org/10.1016/j.ejca.2022.11.035

Author

Chen, Inna M. ; Donia, Marco ; Chamberlain, Christopher A. ; Jensen, Agnete W.P. ; Draghi, Arianna ; Theile, Susann ; Madsen, Kasper ; Hasselby, Jane P. ; Toxværd, Anders ; Høgdall, Estrid ; Lorentzen, Torben ; Wilken, Eva E. ; Geertsen, Poul ; Svane, Inge M. ; Johansen, Julia S. ; Nielsen, Dorte. / Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R). In: European Journal of Cancer. 2023 ; Vol. 180. pp. 125-133.

Bibtex

@article{11d42cccd50343f2b2d6c15136140003,
title = "Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R)",
abstract = "Background: Interleukin-6 blockade and radiation combined with immunotherapy may modulate the tumour microenvironment to overcome immune resistance. We assessed the efficacy of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy (SBRT) in patients with refractory pancreatic cancer (PC). Methods: Patients with PC who had progressive disease (PD) or intolerance to gemcitabine- or fluorouracil-containing regimens were enrolled in Part A of the two-part, single-centre, phase 2 study (NCT04258150). SBRT with 15 Gy was administered on day one of the first cycle. Ipilimumab was administered (1 mg/kg every 6 weeks) for a maximum of two infusions. Nivolumab (6 mg/kg) and tocilizumab (8 mg/kg) were given every four weeks until the PD or unacceptable toxicity, or for up to one year. The primary end-point was the objective response rate, with a threshold of 15%. Results: Twenty-six patients were enrolled and treated between April 17, 2020, and January 25, 2021. The median follow-up time at the time of data cutoff (February 7, 2022) was 4.9 months (interquartile range 2.1–7.7). No responses were observed. Five patients (19%; 95% confidence intervals [CI], 7–39) achieved a stable disease. The median progression-free survival was 1.6 months (95% CI 1.4–1.7), and the median overall survival was 5.3 months (95% CI 2.3–8.0). Overall, 19 (73%) experienced adverse events related to the treatment including two (8%) with grade 3 or higher events. Conclusion: The combination of ipilimumab, nivolumab, tocilizumab, and SBRT in patients with PC did not meet the prespecified criteria for expansion for full accrual.",
keywords = "Ipilimumab, Nivolumab, Pancreatic cancer, Stereotactic body radiotherapy, Tocilizumab, TRIPLE-R",
author = "Chen, {Inna M.} and Marco Donia and Chamberlain, {Christopher A.} and Jensen, {Agnete W.P.} and Arianna Draghi and Susann Theile and Kasper Madsen and Hasselby, {Jane P.} and Anders Toxv{\ae}rd and Estrid H{\o}gdall and Torben Lorentzen and Wilken, {Eva E.} and Poul Geertsen and Svane, {Inge M.} and Johansen, {Julia S.} and Dorte Nielsen",
note = "Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2023",
doi = "10.1016/j.ejca.2022.11.035",
language = "English",
volume = "180",
pages = "125--133",
journal = "European Journal of Cancer, Supplement",
issn = "0959-8049",
publisher = "Pergamon",

}

RIS

TY - JOUR

T1 - Phase 2 study of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy in patients with refractory pancreatic cancer (TRIPLE-R)

AU - Chen, Inna M.

AU - Donia, Marco

AU - Chamberlain, Christopher A.

AU - Jensen, Agnete W.P.

AU - Draghi, Arianna

AU - Theile, Susann

AU - Madsen, Kasper

AU - Hasselby, Jane P.

AU - Toxværd, Anders

AU - Høgdall, Estrid

AU - Lorentzen, Torben

AU - Wilken, Eva E.

AU - Geertsen, Poul

AU - Svane, Inge M.

AU - Johansen, Julia S.

AU - Nielsen, Dorte

N1 - Publisher Copyright: © 2022 The Authors

PY - 2023

Y1 - 2023

N2 - Background: Interleukin-6 blockade and radiation combined with immunotherapy may modulate the tumour microenvironment to overcome immune resistance. We assessed the efficacy of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy (SBRT) in patients with refractory pancreatic cancer (PC). Methods: Patients with PC who had progressive disease (PD) or intolerance to gemcitabine- or fluorouracil-containing regimens were enrolled in Part A of the two-part, single-centre, phase 2 study (NCT04258150). SBRT with 15 Gy was administered on day one of the first cycle. Ipilimumab was administered (1 mg/kg every 6 weeks) for a maximum of two infusions. Nivolumab (6 mg/kg) and tocilizumab (8 mg/kg) were given every four weeks until the PD or unacceptable toxicity, or for up to one year. The primary end-point was the objective response rate, with a threshold of 15%. Results: Twenty-six patients were enrolled and treated between April 17, 2020, and January 25, 2021. The median follow-up time at the time of data cutoff (February 7, 2022) was 4.9 months (interquartile range 2.1–7.7). No responses were observed. Five patients (19%; 95% confidence intervals [CI], 7–39) achieved a stable disease. The median progression-free survival was 1.6 months (95% CI 1.4–1.7), and the median overall survival was 5.3 months (95% CI 2.3–8.0). Overall, 19 (73%) experienced adverse events related to the treatment including two (8%) with grade 3 or higher events. Conclusion: The combination of ipilimumab, nivolumab, tocilizumab, and SBRT in patients with PC did not meet the prespecified criteria for expansion for full accrual.

AB - Background: Interleukin-6 blockade and radiation combined with immunotherapy may modulate the tumour microenvironment to overcome immune resistance. We assessed the efficacy of ipilimumab, nivolumab, and tocilizumab combined with stereotactic body radiotherapy (SBRT) in patients with refractory pancreatic cancer (PC). Methods: Patients with PC who had progressive disease (PD) or intolerance to gemcitabine- or fluorouracil-containing regimens were enrolled in Part A of the two-part, single-centre, phase 2 study (NCT04258150). SBRT with 15 Gy was administered on day one of the first cycle. Ipilimumab was administered (1 mg/kg every 6 weeks) for a maximum of two infusions. Nivolumab (6 mg/kg) and tocilizumab (8 mg/kg) were given every four weeks until the PD or unacceptable toxicity, or for up to one year. The primary end-point was the objective response rate, with a threshold of 15%. Results: Twenty-six patients were enrolled and treated between April 17, 2020, and January 25, 2021. The median follow-up time at the time of data cutoff (February 7, 2022) was 4.9 months (interquartile range 2.1–7.7). No responses were observed. Five patients (19%; 95% confidence intervals [CI], 7–39) achieved a stable disease. The median progression-free survival was 1.6 months (95% CI 1.4–1.7), and the median overall survival was 5.3 months (95% CI 2.3–8.0). Overall, 19 (73%) experienced adverse events related to the treatment including two (8%) with grade 3 or higher events. Conclusion: The combination of ipilimumab, nivolumab, tocilizumab, and SBRT in patients with PC did not meet the prespecified criteria for expansion for full accrual.

KW - Ipilimumab

KW - Nivolumab

KW - Pancreatic cancer

KW - Stereotactic body radiotherapy

KW - Tocilizumab

KW - TRIPLE-R

U2 - 10.1016/j.ejca.2022.11.035

DO - 10.1016/j.ejca.2022.11.035

M3 - Journal article

C2 - 36592507

AN - SCOPUS:85145444560

VL - 180

SP - 125

EP - 133

JO - European Journal of Cancer, Supplement

JF - European Journal of Cancer, Supplement

SN - 0959-8049

ER -

ID: 366987021