Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024
First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 4 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
53 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Safety of immune checkpoint modulators beyond PD-1/PD-L1 and CTLA-4 in solid tumors: a meta-analysis.JNCI cancer spectrum · 2026Pooled it
- Optimal First-line Immune-related Therapy Selection for Advanced Gastric Cancer: A Systematic Review and Network Meta-analysis.Journal of gastrointestinal cancer · 2026Pooled it
- Efficacy and safety of cadonilimab combined with chemotherapy for gastric or gastroesophageal junction adenocarcinoma: a single-arm meta-analysis.Frontiers in immunology · 2026Pooled it
- Haematological toxicities with immune checkpoint inhibitors in digestive system tumors: a systematic review and network meta-analysis of randomized controlled trials.Clinical and experimental medicine · 2025Pooled it
- Anti-LAG-3 Antibody LBL-007 plus Tislelizumab and Chemotherapy as First-Line Therapy for Advanced Nasopharyngeal Carcinoma: A Multicenter Phase 2 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Efficacy and safety of anti-LAG-3 IBI110 in combination with sintilimab and chemotherapy for advanced squamous non-small cell lung cancer: a randomized phase II study.Cancer immunology, immunotherapy : CII · 2026Trial
- Anti-LAG-3 antibody LBL-007 plus anti-PD-1 antibody toripalimab in advanced nasopharyngeal carcinoma and other solid tumors: an open-label, multicenter, phase Ib/II trial.Journal of hematology & oncology · 2025Trial
- Research progress on the molecular mechanisms of PD-1 and LAG-3 synergy in regulating T cell exhaustion and immunotherapy.Annals of medicine · 2026Review
- Favezelimab plus pembrolizumab for anti-PD-1-refractory classic Hodgkin lymphoma: an open-label phase 1/2 study.Blood neoplasia · 2026Article
- Intratumoral PD-1Medical oncology (Northwood, London, England) · 2026Article
- Diagnostic performance of staging laparoscopy after chemotherapy and the prognostic impact of peritoneal disease resolution in advanced gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026Article
- Review
- Article
- Advances in the management of metastatic gastric cancer: current strategies and emerging therapeutics.Nature reviews. Clinical oncology · 2026Review
- Comparative Cost-Effectiveness Analysis of Multiple First-Line Treatments for HER2-Negative Unresectable Advanced or Recurrent Gastric Cancer in Japan.PharmacoEconomics - open · 2026Article
- PD-1-targeted therapeutic strategies for advanced or recurrent gastric and gastroesophageal junction cancer: a systematic review and network meta-analysis.Translational cancer research · 2026Article
- Gastric cancer cells-derived exosomal miR-151a-5p induces an immunosuppressive microenvironment through promoting LAG3Journal of experimental & clinical cancer research : CR · 2026Article
- Development of combinatorial immunotherapy for patients with advanced gastric cancer from the perspective of immunosuppressive mechanisms in the tumor microenvironment.Fukushima journal of medical science · 2026Review
- Safety, survival outcomes, and prognostic factors in conversion surgery for advanced gastric cancer: a sub-analysis of Japanese patients in the CONVO-GC-1 study.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026Article
- Overcoming resistance to anti-PD-1/PD-L1 therapy in cancer.Cancer drug resistance (Alhambra, Calif.) · 2026Review
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeOpen-label phase II study (RELATIVITY-060) to investigate the efficacy and safety of first-line nivolumab, a PD-1-blocking antibody, plus relatlimab, a lymphocyte-activation gene 3 (LAG-3)-blocking antibody, plus chemotherapy in patients with previously untreated advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC).
methodsPatients with unresectable, locally advanced or metastatic GC/GEJC were randomly assigned 1:1 to nivolumab + relatlimab (fixed-dose combination) + chemotherapy or nivolumab + chemotherapy. The primary end point was objective response rate (ORR; per RECIST v1.1 by blinded independent central review [BICR]) in patients whose tumors had LAG-3 expression ≥1%.
resultsOf 274 patients, 138 were randomly assigned to nivolumab + relatlimab + chemotherapy and 136 to nivolumab + chemotherapy. Median follow-up was 11.9 months. In patients with LAG-3 expression ≥1%, BICR-assessed ORR (95% CI) was 48% (38 to 59) in the nivolumab + relatlimab + chemotherapy arm and 61% (51 to 71) in the nivolumab + chemotherapy arm; median progression-free survival (95% CI) by BICR was 7.0 months (5.8 to 8.4) versus 8.3 months (6.9 to 12.1; hazard ratio [HR], 1.41 [95% CI, 0.97 to 2.05]), and median overall survival (95% CI) was 13.5 months (11.9 to 19.1) versus 16.0 months (10.9 to not estimable; HR, 1.04 [95% CI, 0.70 to 1.54]), respectively. Grade 3 or 4 treatment-related adverse events (TRAEs) occurred in 69% and 61% of all treated patients, and 42% and 36% of patients discontinued because of any-grade TRAEs in the nivolumab + relatlimab + chemotherapy and nivolumab + chemotherapy arms, respectively.
conclusionRELATIVITY-060 did not meet its primary end point of improved ORR in patients with LAG-3 expression ≥1% when relatlimab was added to nivolumab + chemotherapy compared with nivolumab + chemotherapy. Further studies are needed to address whether adding anti-LAG-3 to anti-PD-1 plus chemotherapy can benefit specific GC/GEJC patient subgroups.
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