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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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    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 9 of 23.
    EudraCT Number: 2019-002790-58 Sponsor Protocol Number: CA209-74W Start Date*: 2020-09-24
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination with Trans-arterial ChemoEmbolization (TAC...
    Medical condition: Intermediate-stage Hepatocellular Carcinoma (HCC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10049010 Carcinoma hepatocellular LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) FR (Completed) DE (Completed) BE (Completed) CZ (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001030-17 Sponsor Protocol Number: CA209-039 Start Date*: 2018-12-20
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies
    Medical condition: Multiple myeloma (current protocol)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) BE (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003543-11 Sponsor Protocol Number: 16-214-02 Start Date*: 2017-07-10
    Sponsor Name:Nektar Therapeutics
    Full Title: A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Other Anti-Cancer Therapies in Patients with Select Locally Ad...
    Medical condition: Locally Advanced or Metastatic Solid Tumor Malignancies
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002567-96 Sponsor Protocol Number: CA209-7G8 Start Date*: 2021-01-07
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A phase 3, randomized, double-blind trial of nivolumab in combination with intravesical BCG versus standard of care BCG alone in participants with high-risk non-muscle invasive bladder cancer that ...
    Medical condition: 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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Prematurely Ended) NL (Prematurely Ended) GR (Completed) SE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) AT (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001941-26 Sponsor Protocol Number: CA209-742 Start Date*: 2016-11-14
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects with Previously Untreated Unresectable or Metastatic Melanoma
    Medical condition: Subjects with Previously Untreated Unresectable or Metastatic Melanoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10053571 Melanoma LLT
    19.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003866-14 Sponsor Protocol Number: APX005M-002 Start Date*: 2019-02-28
    Sponsor Name:Apexigen, Inc.
    Full Title: A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination with Nivolumab in Subjects with Non-small Cell Lung Cancer and Subjects with Metastati...
    Medical condition: Non-small Cell Lung Cancer and Metastatic Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10029514 Non-small cell lung cancer NOS LLT
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-002382-33 Sponsor Protocol Number: NBK132/1/2020 Start Date*: 2021-04-12
    Sponsor Name:Medical University of Gdansk
    Full Title: Radiation-Free Therapy for the Initial treatment of Good prognosis early non-bulky HL, defined by a low Metabolic Tumor Volume and a negative interim PET after 2 chemotherapy cycles- RAFTING
    Medical condition: Early stage classical Hodgkin Lymphoma (cHL) without bulky lesions and constitutional symptoms
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10080208 Classical Hodgkin lymphoma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004606-60 Sponsor Protocol Number: BP42772 Start Date*: 2021-06-22
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A 3-ARM, RANDOMIZED, BLINDED, ACTIVE-CONTROLLED, PHASE II STUDY OF RO7121661, A PD1-TIM3 BISPECIFIC ANTIBODY AND RO7247669, A PD1-LAG3 BISPECIFIC ANTIBODY, COMPARED WITH NIVOLUMAB IN PARTICIPANTS W...
    Medical condition: Advanced or metastatic squamous cell carcinoma of the esophagus
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10015362 Esophageal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Trial now transitioned) DK (Trial now transitioned) HU (Trial now transitioned) BE (Completed) FR (Trial now transitioned) IT (Trial now transitioned) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001984-35 Sponsor Protocol Number: M16OPN Start Date*: 2017-06-22
    Sponsor Name:Antoni van leeuwenhoek ziekenhuis
    Full Title: Multicenter Phase 2 Study to Identify of the Optimal neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo)
    Medical condition: Patients with stage III melanoma
    Disease: Version SOC Term Classification Code Term Level
    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: SE (Ongoing) AT (Prematurely Ended) GB (GB - no longer in EU/EEA) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001585-42 Sponsor Protocol Number: CA209-8KX Start Date*: 2019-01-09
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Phase I/II pharmacokinetic multi-tumor study of subcutaneous formulation of nivolumab monotherapy
    Medical condition: The study population will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: non-small cell lung cancer (NSCLC); renal ce...
    Disease: Version SOC Term Classification Code Term Level
    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) 10067946 Renal cell carcinoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027481 Metastatic melanoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073071 Hepatocellular carcinoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Ongoing) GB (GB - no longer in EU/EEA) ES (Ongoing) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001167-12 Sponsor Protocol Number: IMMUNED Start Date*: 2015-05-21
    Sponsor Name:University of Essen
    Full Title: A Phase II Randomized, Double-Blind Trial of Immunotherapy with Nivolumab or Nivolumab plus Ipilimumab versus Double-Placebo Control as a Post-Surgical/Post-Radiation Treatment for Stage IV Melanom...
    Medical condition: Stage IV melanoma with no evidence of disease after surgery or radiotherapy
    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: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002108-15 Sponsor Protocol Number: CA044-001 Start Date*: 2018-09-25
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Phase 1/2 Study of BMS-986310 Administered Alone and in Combination with Nivolumab in Participants with 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: BE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000169-60 Sponsor Protocol Number: CA209-755 Start Date*: 2017-05-23
    Sponsor Name:VU University Medical Center
    Full Title: A phase 2 study of nivolumab combined with daratumumab with or without low dose cyclophosphamide in relapsed/refractory multiple myeloma
    Medical condition: relapsed/refractory multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004851 10028229 Multiple myelomas HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002672-38 Sponsor Protocol Number: CA209-722 Start Date*: 2017-10-25
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Open-Label, Randomized Trial of Nivolumab (BMS-936558) plus Pemetrexed/Platinum or Nivolumab plus Ipilimumab (BMS-734016) vs Pemetrexed plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Ca...
    Medical condition: Subjects with EGFR mutation, T790M negative NSCLC who failed first line (1L) EGFR TKI therapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029515 Non-small cell lung cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003084-21 Sponsor Protocol Number: cHL-PG01 Start Date*: 2020-01-13
    Sponsor Name:PROF.BRUNANGELO FALINI, DR.ENRICO TIACCI. DIPARTIMENTO DI MEDICINA, UNIVERSITA' DI PERUGIA
    Full Title: A phase-II academic trial testing, in two parallel non-randomized cohorts, the combination of ruxolitinib (JAK1/2 inhibitor) with brentuximab or nivolumab in relapsed or refractory classical Hodgki...
    Medical condition: Patients with relapsed or refractory cHL that has not responded to, or has progressed after, the previous treatment
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10020328 Hodgkin's lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002257-37 Sponsor Protocol Number: UC-0105/1611 Start Date*: 2017-02-10
    Sponsor Name:UNICANCER
    Full Title: Secured access to nivolumab for adult patients with selected rare cancer types
    Medical condition: Unresectable locally advanced or metastatic, non-clear cell renal cell carcinoma, rare head and neck cancer, rare skin cancer, MSI-nonCRC or penile cancer, which is resistant or refractory to stand...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002755-29 Sponsor Protocol Number: CA209-9DX Start Date*: 2018-11-19
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or ...
    Medical condition: Hepatocellular Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073071 Hepatocellular carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004284-27 Sponsor Protocol Number: CA043-001 Start Date*: 2022-01-17
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors
    Medical condition: Advanced solid tumors (squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), cutaneous melanoma, triple-negative breast cancer (TNBC), renal cell carcinoma (RCC)...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004026-31 Sponsor Protocol Number: CA224-104 Start Date*: 2021-03-22
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 2 Randomized Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Re...
    Medical condition: Non Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10025048 Lung cancer non-small cell recurrent LLT
    20.0 100000004864 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned) DE (Trial now transitioned) AT (Completed) NL (Ongoing) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002307-26 Sponsor Protocol Number: 0216-ASG Start Date*: 2016-09-15
    Sponsor Name:AIO-Studien-gGmbH
    Full Title: A phase II single arm clinical trial of a Tailored ImmunoTherapy Approach with Nivolumab in subjects with metastatic or advanced Renal Cell Carcinoma
    Medical condition: subjects with previously untreated (1st line) or pretreated (2nd line), intermediate or high risk, advanced or metastatic renal cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10038400 Renal carcinoma stage IV LLT
    20.0 100000004864 10038399 Renal carcinoma stage III LLT
    20.0 100000004864 10050076 Metastatic renal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) AT (Completed) CZ (Completed) ES (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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