Clinical trial · Interventional
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
NCT02872116CI-TRIAL-00093256CheckMate649completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Nivolumab + Ipilimumab
- description
- Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy Enrollment is closed for this arm
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
- type
- ACTIVE_COMPARATOR
- label
- XELOX (Oxaliplatin + Capecitabine)
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
- interventionNames
- Drug: Oxaliplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female at least 18 years of age * Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out * Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months * Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work * Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study Exclusion Criteria: * Presence of tumor cells in the brain or spinal cord that have not been treated * Active known or suspected autoimmune disease * Any serious or uncontrolled medical disorder or active infection * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Any positive test result for hepatitis B or C indicating acute or chronic infection Other protocol-defined inclusion/exclusion criteria apply
References
Publications (6)
- DERIVEDLin D, Quan W, Garretson M, Chirikov V, Chen C, Singh P, Davis C, Sugarman R. Q-TWiST analysis of first-line nivolumab plus chemotherapy versus chemotherapy in patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma from CheckMate 649: 4-year follow-up results. Gastric Cancer. 2025 Sep;28(5):935-944. doi: 10.1007/s10120-025-01634-6. Epub 2025 Jul 9. PMID 40632415
- DERIVEDJanjigian YY, Ajani JA, Moehler M, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary JM, Elimova E, Karamouzis M, Bruges R, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Zander T, Kowalyszyn R, Pazo-Cid R, Schenker M, Feeny K, Wang R, Lei M, Chen C, Nathani R, Shitara K. First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial. J Clin Oncol. 2024 Jun 10;42(17):2012-2020. doi: 10.1200/JCO.23.01601. Epub 2024 Feb 21. PMID 38382001
- DERIVEDMoehler M, Xiao H, Blum SI, Elimova E, Cella D, Shitara K, Ajani JA, Janjigian YY, Garrido M, Shen L, Yamaguchi K, Liu T, Schenker M, Kowalyszyn R, Bragagnoli AC, Bruges R, Montesarchio V, Pazo-Cid R, Hunter S, Davenport E, Wang J, Kondo K, Li M, Wyrwicz L. Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649. J Clin Oncol. 2023 Dec 10;41(35):5388-5399. doi: 10.1200/JCO.23.00170. Epub 2023 Sep 15. PMID 37713657
- DERIVEDJanjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Wyrwicz L, Yamaguchi K, Skoczylas T, Bragagnoli AC, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. A plain language summary of the CheckMate 649 study: nivolumab in combination with chemotherapy compared to chemotherapy alone for untreated advanced or metastatic cancer of the stomach or esophagus. Future Oncol. 2023 Apr;19(11):739-752. doi: 10.2217/fon-2022-1149. Epub 2023 Mar 15. PMID 36919706
- Liu T, Bai Y, Lin X, Li W, Wang J, Zhang X, Pan H, Bai C, Bai L, Cheng Y, Zhang J, Zhong H, Ba Y, Hu W, Xu R, Guo W, Qin S, Yang N, Lu J, Shitara K, Lei M, Li M, Bao N, Chen T, Shen L. First-line nivolumab plus chemotherapy vs chemotherapy in patients with advanced gastric, gastroesophageal junction and esophageal adenocarcinoma: CheckMate 649 Chinese subgroup analysis. Int J Cancer. 2023 Feb 15;152(4):749-760. doi: 10.1002/ijc.34296. Epub 2022 Oct 31.