Clinical trial · Interventional
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors
NCT02488759CI-TRIAL-00071243CheckMate358completedPhase 1 / Phase 2Results 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 purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors: * Anal canal cancer-No longer enrolling this tumor type * Cervical cancer * Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type * Merkel Cell Cancer * Penile cancer-No longer enrolling this tumor type * Vaginal and vulvar cancer-No longer enrolling this tumor type * Nasopharyngeal Cancer - No longer enrolling this tumor type * Head and Neck Cancer - No longer enrolling this tumor type
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Various Advanced Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Drug | Daratumumab | ALIAS |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Relatlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Cohort
- description
- Nivolumab intravenous infusion as specified \*\*Not participating: Japan, Korea, and Taiwan
- interventionNames
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Metastatic Monotherapy Cohort
- description
- Nivolumab intravenous infusion as specified
- interventionNames
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Nivolumab plus Ipilimumab Cohort
- description
- Nivolumab intravenous infusion as specified with Ipilimumab intravenous infusion as specified \*\*Not participating: Belgium, France and Germany Cohort expansion participating countries: Spain, US, UK, Netherlands, Japan and Mexico \*\*Not participating in cohort expansion: France, Germany, Korea and Taiwan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types): 1. Merkel Cell Carcinoma 2. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type) 3. Nasopharyngeal Carcinoma 4. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva 5. Squamous cell carcinoma of the Head and Neck 6. Squamous cell carcinoma of the anal canal and penis 7. Recurrent/metastatic SCC of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer Combination B expansion cohort * Measurable disease by CT or MRI * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen) * Men and women of age 18 or older Exclusion Criteria: * Active brain metastases or leptomeningeal metastases * Patients with active, known or suspected autoimmune disease * Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * Patients with hepatitis * Patients with HIV * Pregnant or breastfeeding women
References
Publications (7)
- DERIVEDBhatia S, Topalian SL, Sharfman W, Meyer T, Steven N, Lao CD, Farinas-Madrid L, Devriese LA, Moore K, Ferris RL, Honma Y, Elias I, Srirangam A, Garnett-Benson C, Lee M, Nghiem P. Nivolumab With or Without Ipilimumab in Patients With Recurrent or Metastatic Merkel Cell Carcinoma: A Nonrandomized, Open-Label, International, Multicenter Phase I/II Study. J Clin Oncol. 2025 Mar 20;43(9):1137-1147. doi: 10.1200/JCO-24-02138. Epub 2025 Jan 31. PMID 39889250
- DERIVEDOaknin A, Moore K, Meyer T, Lopez-Picazo Gonzalez J, Devriese LA, Amin A, Lao CD, Boni V, Sharfman WH, Park JC, Tahara M, Topalian SL, Magallanes M, Molina Alavez A, Khan TA, Copigneaux C, Lee M, Garnett-Benson C, Wang X, Naumann RW. Nivolumab with or without ipilimumab in patients with recurrent or metastatic cervical cancer (CheckMate 358): a phase 1-2, open-label, multicohort trial. Lancet Oncol. 2024 May;25(5):588-602. doi: 10.1016/S1470-2045(24)00088-3. Epub 2024 Apr 9. PMID 38608691
- DERIVEDPulliam T, Jani S, Jing L, Ryu H, Jojic A, Shasha C, Zhang J, Kulikauskas R, Church C, Garnett-Benson C, Gooley T, Chapuis A, Paulson K, Smith KN, Pardoll DM, Newell EW, Koelle DM, Topalian SL, Nghiem P. Circulating cancer-specific CD8 T cell frequency is associated with response to PD-1 blockade in Merkel cell carcinoma. Cell Rep Med. 2024 Feb 20;5(2):101412. doi: 10.1016/j.xcrm.2024.101412. Epub 2024 Feb 10. PMID 38340723
- DERIVEDFerris RL, Spanos WC, Leidner R, Goncalves A, Martens UM, Kyi C, Sharfman W, Chung CH, Devriese LA, Gauthier H, Chiosea SI, Vujanovic L, Taube JM, Stein JE, Li J, Li B, Chen T, Barrows A, Topalian SL. Neoadjuvant nivolumab for patients with resectable HPV-positive and HPV-negative squamous cell carcinomas of the head and neck in the CheckMate 358 trial. J Immunother Cancer. 2021 Jun;9(6):e002568. doi: 10.1136/jitc-2021-002568. PMID 34083421
- DERIVEDTopalian SL, Bhatia S, Amin A, Kudchadkar RR, Sharfman WH, Lebbe C, Delord JP, Dunn LA, Shinohara MM, Kulikauskas R, Chung CH, Martens UM, Ferris RL, Stein JE, Engle EL, Devriese LA, Lao CD, Gu J, Li B, Chen T, Barrows A, Horvath A, Taube JM, Nghiem P. Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial. J Clin Oncol. 2020 Aug 1;38(22):2476-2487. doi: 10.1200/JCO.20.00201. Epub 2020 Apr 23.