An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
NCT ID: NCT02488759
Last Updated: 2023-11-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
578 participants
INTERVENTIONAL
2015-10-13
2022-10-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
NCT03233711
Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
NCT02314169
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
NCT02060188
Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer
NCT04751370
EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients
NCT04444921
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neoadjuvant Cohort
Nivolumab intravenous infusion as specified
\*\*Not participating: Japan, Korea, and Taiwan
Nivolumab
Metastatic Monotherapy Cohort
Nivolumab intravenous infusion as specified
Nivolumab
Nivolumab plus Ipilimumab Cohort
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
Nivolumab
Ipilimumab
Nivolumab plus Relatlimab Cohort
Nivolumab intravenous infusion as specified with Relatlimab intravenous infusion as specified
\*\* Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands
Enrollment is closed for this cohort
Nivolumab
Relatlimab
Nivolumab plus Daratumumab Cohort
Nivolumab intravenous infusion as specified with Daratumumab intravenous infusion as specified
\*\*Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands
Enrollment is closed for this cohort
Nivolumab
Daratumumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab
Ipilimumab
Relatlimab
Daratumumab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0033
Tampa, Florida, United States
Local Institution - 0003
Atlanta, Georgia, United States
Local Institution - 0023
Lutherville, Maryland, United States
Local Institution - 0002
Boston, Massachusetts, United States
Local Institution - 0019
Boston, Massachusetts, United States
Local Institution - 0020
Boston, Massachusetts, United States
Local Institution - 0035
Ann Arbor, Michigan, United States
Local Institution - 0036
New York, New York, United States
Local Institution - 0022
Charlotte, North Carolina, United States
Local Institution - 0005
Oklahoma City, Oklahoma, United States
Local Institution - 0004
Portland, Oregon, United States
Local Institution - 0029
Pittsburgh, Pennsylvania, United States
Local Institution - 0001
Sioux Falls, South Dakota, United States
Local Institution - 0021
Seattle, Washington, United States
Local Institution - 0012
Brussels, , Belgium
Local Institution - 0014
Brussels, , Belgium
Local Institution - 0013
Brussels, , Belgium
Local Institution - 0031
Marseille, , France
Local Institution - 0038
Paris, , France
Local Institution - 0032
Toulouse, , France
Local Institution - 0030
Vlllejuif, , France
Local Institution - 0027
Essen, , Germany
Local Institution - 0028
Heilbronn, , Germany
Local Institution - 0039
Kashiwa-shi, Chiba, Japan
Local Institution - 0040
Chuo-ku, Tokyo, Japan
Local Institution - 0041
Koto-ku, Tokyo, Japan
Local Institution - 0056
Mexico City, Mexico City, Mexico
Local Institution
Oaxaca City, Oaxaca, Mexico
Local Institution - 0046
Mérida, Yucatán, Mexico
Local Institution - 0011
Amsterdam, , Netherlands
Local Institution - 0034
Utrecht, , Netherlands
Local Institution - 0024
Seoul, , South Korea
Local Institution - 0018
Barcelona, , Spain
Local Institution - 0017
Madrid, , Spain
Local Institution - 0016
Navarra, , Spain
Local Institution - 0037
Tainan City, , Taiwan
Local Institution - 0026
Taipei, , Taiwan
Local Institution - 0006
Glasgow, Lanarkshire, United Kingdom
Local Institution - 0010
Birmingham, West Midlands, United Kingdom
Local Institution - 0008
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bhatia 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.
Oaknin 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.
Pulliam 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.
Ferris 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.
Topalian 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.
Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, Lopez-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN. Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial. J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.
Appelbaum J, Wells D, Hiatt JB, Steinbach G, Stewart FM, Thomas H, Nghiem P, Kapur RP, Thompson JA, Bhatia S. Fatal enteric plexus neuropathy after one dose of ipilimumab plus nivolumab: a case report. J Immunother Cancer. 2018 Aug 31;6(1):82. doi: 10.1186/s40425-018-0396-9.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-000230-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-358
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.