S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE)

Anwaar Saeed; Sarah Colby; Paul Eliezer Oberstein; Dan G. Duda; Robin Park; Rajiv Agarwal; Colmar Figueroa-Moseley; Riha Vaidya; Joseph M. Unger; Katherine A. Guthrie; Flavio G. Rocha; Maheswari Senthil; Rachael A. Safyan; Zev A. Wainberg; Syma Iqbal; E. Gabriela Chiorean; Philip A. Philip

doi:10.1080/14796694.2025.2485020

S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE)

Anwaar Saeed, Sarah Colby, Paul Eliezer Oberstein, Dan G. Duda, Robin Park, Rajiv Agarwal, Colmar Figueroa-Moseley, Riha Vaidya, Joseph M. Unger, Katherine A. Guthrie, Flavio G. Rocha, Maheswari Senthil, Rachael A. Safyan, Zev A. Wainberg, Syma Iqbal, E. Gabriela Chiorean, Philip A. Philip

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Combined anti-programmed death (PD)-1 and vascular endothelial growth factor (VEGF) inhibitor regimens are potentially synergistic and have high efficacy against various advanced solid tumors. The addition of anti-PD-1 to frontline chemotherapy became the standard of care in patients with advanced gastric/gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma. However, whether the continuation of anti-PD-1 therapy combined with second-line ramucirumab (anti-VEGFR-2 antibody) and paclitaxel chemotherapy has clinical benefits remains an open question. PARAMUNE is a randomized phase II/III study evaluating the efficacy of nivolumab combined with paclitaxel and ramucirumab compared to paclitaxel and ramucirumab in second-line PD-L1 combined positive score (CPS) ≥ 1, human epidermal growth factor receptor (HER)-2 negative advanced G/GEJ/E adenocarcinoma. The primary endpoints are progression-free survival (PFS) and overall survival (OS) for the phase II and phase III parts, respectively. Trial registration number: NCT06203600.

Original language	English (US)
Pages (from-to)	1325-1331
Number of pages	7
Journal	Future Oncology
Volume	21
Issue number	11
DOIs	https://doi.org/10.1080/14796694.2025.2485020
State	E-pub ahead of print - Mar 28 2025

Keywords

anti-programmed death-1
combined positive score
gastric, gastroesophageal junction, or esophageal cancer
Immunotherapy
paclitaxel
ramucirumab
vascular endothelial growth factor

ASJC Scopus subject areas

Oncology
Cancer Research

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10.1080/14796694.2025.2485020

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Saeed, A., Colby, S., Oberstein, P. E., Duda, D. G., Park, R., Agarwal, R., Figueroa-Moseley, C., Vaidya, R., Unger, J. M., Guthrie, K. A., Rocha, F. G., Senthil, M., Safyan, R. A., Wainberg, Z. A., Iqbal, S., Chiorean, E. G., & Philip, P. A. (2025). S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE). Future Oncology, 21(11), 1325-1331. Advance online publication. https://doi.org/10.1080/14796694.2025.2485020

Saeed, A, Colby, S, Oberstein, PE, Duda, DG, Park, R, Agarwal, R, Figueroa-Moseley, C, Vaidya, R, Unger, JM, Guthrie, KA, Rocha, FG, Senthil, M, Safyan, RA, Wainberg, ZA, Iqbal, S, Chiorean, EG & Philip, PA 2025, 'S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE)', Future Oncology, vol. 21, no. 11, pp. 1325-1331. https://doi.org/10.1080/14796694.2025.2485020

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abstract = "Combined anti-programmed death (PD)-1 and vascular endothelial growth factor (VEGF) inhibitor regimens are potentially synergistic and have high efficacy against various advanced solid tumors. The addition of anti-PD-1 to frontline chemotherapy became the standard of care in patients with advanced gastric/gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma. However, whether the continuation of anti-PD-1 therapy combined with second-line ramucirumab (anti-VEGFR-2 antibody) and paclitaxel chemotherapy has clinical benefits remains an open question. PARAMUNE is a randomized phase II/III study evaluating the efficacy of nivolumab combined with paclitaxel and ramucirumab compared to paclitaxel and ramucirumab in second-line PD-L1 combined positive score (CPS) ≥ 1, human epidermal growth factor receptor (HER)-2 negative advanced G/GEJ/E adenocarcinoma. The primary endpoints are progression-free survival (PFS) and overall survival (OS) for the phase II and phase III parts, respectively. Trial registration number: NCT06203600.",

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doi = "10.1080/14796694.2025.2485020",

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AU - Oberstein, Paul Eliezer

AU - Duda, Dan G.

AU - Park, Robin

AU - Agarwal, Rajiv

AU - Figueroa-Moseley, Colmar

AU - Vaidya, Riha

AU - Unger, Joseph M.

AU - Guthrie, Katherine A.

AU - Rocha, Flavio G.

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AU - Safyan, Rachael A.

AU - Wainberg, Zev A.

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AU - Philip, Philip A.

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AB - Combined anti-programmed death (PD)-1 and vascular endothelial growth factor (VEGF) inhibitor regimens are potentially synergistic and have high efficacy against various advanced solid tumors. The addition of anti-PD-1 to frontline chemotherapy became the standard of care in patients with advanced gastric/gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma. However, whether the continuation of anti-PD-1 therapy combined with second-line ramucirumab (anti-VEGFR-2 antibody) and paclitaxel chemotherapy has clinical benefits remains an open question. PARAMUNE is a randomized phase II/III study evaluating the efficacy of nivolumab combined with paclitaxel and ramucirumab compared to paclitaxel and ramucirumab in second-line PD-L1 combined positive score (CPS) ≥ 1, human epidermal growth factor receptor (HER)-2 negative advanced G/GEJ/E adenocarcinoma. The primary endpoints are progression-free survival (PFS) and overall survival (OS) for the phase II and phase III parts, respectively. Trial registration number: NCT06203600.

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KW - combined positive score

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KW - Immunotherapy

KW - paclitaxel

KW - ramucirumab

KW - vascular endothelial growth factor

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ER -

S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE)

Abstract

Keywords

ASJC Scopus subject areas

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