A multicenter, prospective, observational study of nivolumab readministration for advanced gastric cancer (NIVO RETURNS)
Combination treatment with an anti-programmed cell death-1 (PD-1) antibody, an immune checkpoint inhibitor (ICI), and chemotherapy is the standard treatment for patients with HER2-negative advanced gastric/esophagogastric cancer (AGC). ICI re-administration has been reported to have a clinical benefit for patients with lung cancer or melanoma. However, data on patients with AGC have not yet been collected. We plan to conduct a prospective, multicenter, observational NIVO RETURNS study to evaluate the efficacy and safety of nivolumab monotherapy re-administration in patients with AGC refractory to initial anti-PD-1 or anti-programmed cell death ligand-1 (PD-L1) antibody treatment. Patients who have achieved clinical benefits (complete response, partial response, or stable disease for ≥ 6 months) from prior treatment, including anti-PD-1/PD-L1 therapy, will be included. The primary endpoint will be the objective response rate to nivolumab re-administration. We anticipate that our findings will contribute to the improvement of survival outcomes as later-line treatment for AGC.<b>Clinical trial registration:</b> UMIN000050515, UMIN000051044.
Authors
- Takayuki Ando (ORCID: https://orcid.org/0000-0001-8369-8536)
- Masataka Taguri (ORCID: https://orcid.org/0000-0001-8902-0056)
- Hiroki Nishikawa (ORCID: https://orcid.org/0009-0009-0488-3297)
- Takuro Mizukami (ORCID: https://orcid.org/0000-0002-9960-5629)
- Keiji Sugiyama (ORCID: https://orcid.org/0000-0002-8980-4739)
- Yukiya Narita (ORCID: https://orcid.org/0000-0002-8018-0077)
- Masanobu Takahashi
- Michio Nakamura (ORCID: https://orcid.org/0000-0002-1509-9811)
- Hiroshi Kagamu
- Hiroko Kodama (ORCID: https://orcid.org/0009-0003-4548-4109)
- Kei Muro (ORCID: https://orcid.org/0000-0002-5572-743X)
- Toshifumi Yamaguchi (ORCID: https://orcid.org/0000-0003-1399-1918)
- Shunichiro Orihara (ORCID: https://orcid.org/0000-0003-0168-1250)
- Seiichiro Mitani (ORCID: https://orcid.org/0000-0003-0033-8741)
- Toshikazu Moriwaki (ORCID: https://orcid.org/0000-0001-7702-122X)
- Ayumu Hosokawa (ORCID: https://orcid.org/0009-0003-6913-6950)
- Azusa Komori (ORCID: https://orcid.org/0000-0003-0591-1025)
Institutions
- Tokyo Medical University (JP)
- NTT Medical Center (JP)
- Kurashiki Central Hospital (JP)
- Tohoku University Hospital (JP)
- Saitama International Medical Center (JP)
- Aichi Cancer Center (JP)
- University of Miyazaki Hospital (JP)
- Shikoku Cancer Center (JP)
- Sapporo City General Hospital (JP)
- Nagoya Medical Center (JP)
- University of Toyama (JP)
- Saitama Medical University (JP)
- Osaka University of Pharmaceutical Sciences (JP)
- Kindai University (JP)
Publication Details
- Journal
- Future Oncology
- Published
- 2025-05-08
- DOI
- https://doi.org/10.1080/14796694.2025.2500918
- Citations
- 1
- Primary Topic
- Gastric Cancer Management and Outcomes
- Type
- article
- Field-Weighted Citation Impact
- 1.52