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Clinical trials for nivolumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    446 result(s) found for: nivolumab. Displaying page 2 of 23.
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    EudraCT Number: 2017-004692-31 Sponsor Protocol Number: CA017-078 Start Date*: 2019-03-18
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy with Nivolumab...
    Medical condition: Bladder Cancer Muscle-Invasive Bladder Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10022877 Invasive bladder cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) NO (Trial now transitioned) NL (Trial now transitioned) FI (Trial now transitioned) GR (Trial now transitioned) ES (Ongoing) PT (Completed) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000597-11 Sponsor Protocol Number: CA022-001 Start Date*: 2018-07-27
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination with Nivolumab in Advanced Solid Tumors.
    Medical condition: Advanced Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) DE (Prematurely Ended) BE (Completed) NO (Completed) NL (Completed) PL (Prematurely Ended) FI (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001384-23 Sponsor Protocol Number: 65512-SAFESTOP Start Date*: 2018-11-08
    Sponsor Name:Erasmus Medical Center
    Full Title: Safe Stop Trial: observational study of the STOP & GO strategy of PD-1 blockade in advanced melanoma patients upon achieving a complete or partial response
    Medical condition: malignant and not otherwise specified skin neoplasms
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10040900 Skin neoplasms malignant and unspecified HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002811-16 Sponsor Protocol Number: CA209-587 Start Date*: 2017-01-10
    Sponsor Name:Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg
    Full Title: Phase II Study of Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) in Patients with Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Skin
    Medical condition: Locally Advanced/Metastatic Squamous Cell Carcinoma of the Skin
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003655-15 Sponsor Protocol Number: CA209-67T Start Date*: 2021-06-02
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carci...
    Medical condition: Metastatic Clear Cell Renal Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10050076 Metastatic renal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned) PT (Trial now transitioned) FI (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-003630-23 Sponsor Protocol Number: CA209-227 Start Date*: 2015-09-30
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab, versus platinum doublet chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lun...
    Medical condition: Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025048 Lung cancer non-small cell recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed) NL (Completed) BE (Completed) IE (Completed) CZ (Completed) AT (Completed) PL (Completed) HU (Completed) FI (Completed) GR (Completed) RO (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003738-34 Sponsor Protocol Number: CA209-143 Start Date*: 2014-06-05
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Randomized Phase 3 Open Label Study of Nivolumab versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Adult Subjects with Recurrent Glioblastoma (GBM)...
    Medical condition: Recurrent glioblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed) BE (Completed) DK (Completed) PL (Completed) FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-004502-34 Sponsor Protocol Number: CA209-914 Start Date*: 2017-08-11
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Parti...
    Medical condition: Early stage localized Renal Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10038395 Renal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) DE (Prematurely Ended) BE (Completed) CZ (Completed) NL (Prematurely Ended) GB (GB - no longer in EU/EEA) FR (Ongoing) ES (Prematurely Ended) IT (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-002605-38 Sponsor Protocol Number: CA224-020 Start Date*: 2015-08-26
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1...
    Medical condition: Neoplasms by site
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017758 Gastric cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073071 Hepatocellular carcinoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10053571 Melanoma LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067821 Head and neck cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067946 Renal cell carcinoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) FI (Trial now transitioned) GB (GB - no longer in EU/EEA) NO (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) Outside EU/EEA IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001423-40 Sponsor Protocol Number: CA045-001 Start Date*: 2018-10-22
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma
    Medical condition: Untreated unresectable or metastatic melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) FR (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) NL (Completed) GR (Completed) BE (Completed) PL (Completed) PT (Completed) Outside EU/EEA SE (Completed) FI (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-001195-35 Sponsor Protocol Number: CA209-9LA Start Date*: 2017-09-20
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
    Medical condition: Stage IV Non-Small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) IE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Completed) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000917-34 Sponsor Protocol Number: 20-214-29/CA045-022 Start Date*: Information not available in EudraCT
    Sponsor Name:Nektar Therapeutics
    Full Title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk...
    Medical condition: Resected Stage IIIA (lymph node metastasis > 1 mm)/B/C/D and IV melanoma with no evidence of disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025650 Malignant melanoma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) FR (Completed) GR (Completed) PL (Completed) AT (Completed) PT (Prematurely Ended) DE (Completed) NL (Completed) GB (GB - no longer in EU/EEA) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004695-35 Sponsor Protocol Number: CA209-8Y8 Start Date*: 2019-06-10
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined with Ipilimumab versus Nivolumab Monotherapy for Patients with Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- ...
    Medical condition: Advanced Renal Cell Carcinoma with Intermediate- or Poor-Risk Factors
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067946 Renal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) CZ (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) PT (Completed) GR (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-004920-67 Sponsor Protocol Number: CA209-511 Start Date*: 2016-05-30
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously ...
    Medical condition: Subjects with Previously Untreated, Unresectable or Metastatic Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) DK (Completed) GB (GB - no longer in EU/EEA) NL (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002505-11 Sponsor Protocol Number: CA009-002 Start Date*: 2016-06-23
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination with Nivolumab (BMS-936558, anti-PD-1 Monoclonal A...
    Medical condition: Advanced Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) ES (Completed) DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003881-14 Sponsor Protocol Number: CA209-901 Start Date*: 2017-06-12
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated ...
    Medical condition: Untreated Unresectable or Metastatic Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing) SE (Completed) FI (Completed) FR (Trial now transitioned) GR (Trial now transitioned) NO (Trial now transitioned) CZ (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004362-34 Sponsor Protocol Number: CA209-8TT Start Date*: 2020-03-24
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Pan Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS sponsored Trials Investigating Nivolumab and Other Cancer Therapies
    Medical condition: pan tumor
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007050 Cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) NO (Completed) PL (Trial now transitioned) GR (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Completed) PT (Completed) CZ (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003946-99 Sponsor Protocol Number: GETHI021 Start Date*: 2017-06-19
    Sponsor Name:Grupo Español de Tumores Huérfanos e Infrecuentes (GETHI)
    Full Title: A multicenter phase 2 study of nivolumab combined with ipilimumab in patients with pediatric solid tumors presenting in adulthood
    Medical condition: Pediatric solid tumors presenting in adulthood
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-001840-23 Sponsor Protocol Number: CA209-038 Start Date*: 2019-07-12
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: An exploratory study of the biologic effects of Nivolumab and Ipilimumab Monotherapy and Nivolumab in Combination with Ipilimumab Treatment in Subjects with Advanced melanoma (Unresectable or metas...
    Medical condition: Advanced or Metastatic Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10053571 Melanoma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001939-38 Sponsor Protocol Number: NIVINIHO Start Date*: 2018-04-18
    Sponsor Name:LYSARC
    Full Title: A prospective phase II study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with classical Hodgkin Lymphoma and coexisting medical conditions
    Medical condition: patients aged 61 years and older, with classical Hodgkin lymphoma and coexisting medical conditions
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10080208 Classical Hodgkin lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed)
    Trial results: View results
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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