drugset / Trial / NCT03662659
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.
Timeline
- Start
- 2018-10-16
- Primary completion
- 2020-08-27
- Completion
- 2024-01-18
Outcome
Missed primary endpoint
paper RELATIVITY-060 did not meet its primary end point of improved ORR PMID 38723227 ↗
Publications
- Hegewisch-Becker S, Mendez G, Chao J, Nemecek R, Feeney K, Van Cutsem E, Al-Batran SE, Mansoor W, Maisey N, Pazo Cid R, Burge M, Perez-Callejo D, Hipkin RW, Mukherjee S, Lei M, Tang H, Suryawanshi S, Kelly RJ, Tebbutt NC. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. J Clin Oncol. 2024 Jun 10;42(17):2080-2093. doi: 10.1200/JCO.23.01636. Epub 2024 May 9.
- Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Relatlimab | Monoclonal antibody | — | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | Tegafur/gimeracil/oteracil potassium | Unknown | — | — |
| Background | fluorouracil | Small molecule | — | — |