Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Monotherapy

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   44346   clinical trials with a EudraCT protocol, of which   7374   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    2,127 result(s) found for: Monotherapy. Displaying page 50 of 107.
    EudraCT Number: 2017-001459-30 Sponsor Protocol Number: 331-10-236 Start Date*: 2019-03-07
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc
    Full Title: A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10039636 Schizophrenia simple LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) PL (Completed) BG (Prematurely Ended) FR (Completed) IT (Completed) RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003284-22 Sponsor Protocol Number: AI463080 Start Date*: 2007-03-19
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Patients with Chronic HBV Infection: The REALM Study
    Medical condition: CHRONIC HEPATITIS B VIRUS INFECTION
    Disease: Version SOC Term Classification Code Term Level
    8.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) ES (Completed) IT (Completed) PT (Completed) GR (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-003747-37 Sponsor Protocol Number: MK-7902-005 Start Date*: 2019-03-07
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)
    Medical condition: Triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), or biliary tract cancers (BTC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028997 Neoplasm malignant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: (No results available)
    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: 2007-005434-37 Sponsor Protocol Number: IM101-174 Start Date*: 2008-07-24
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arth...
    Medical condition: RHEUMATOID ARTHRITIS, NOS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IE (Completed) HU (Completed) GB (Completed) BE (Completed) DE (Completed) NL (Completed) IT (Completed) AT (Prematurely Ended) GR (Completed)
    Trial results: View results
    EudraCT Number: 2015-001274-17 Sponsor Protocol Number: CA209-401 Start Date*: 2016-04-22
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Clinical Trial of Nivolumab (BMS-936558) Combined with Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects with Histologically Confirmed Stage III (Unresectable) or Stage...
    Medical condition: Stage III (Unresectable) or Stage IV 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) SE (Completed) IE (Completed) FI (Completed) GB (GB - no longer in EU/EEA) NO (Completed) AT (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-004555-16 Sponsor Protocol Number: M20-429 Start Date*: 2022-04-25
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms
    Medical condition: Relapsed/refractory Burkitt's or Burkitt-like lymphoma/leukemia, Diffuse large B-cell lymphoma , or other aggressive mature (CD20+) B-cell lymphomas
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10006596 Burkitt's lymphomas HLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10003903 B-cell lymphoma refractory PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012822 Diffuse large B-cell lymphoma refractory PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005437-53 Sponsor Protocol Number: ITCC053 Start Date*: 2016-11-03
    Sponsor Name:Erasmus Medical Center
    Full Title: A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies Study ITCC 053
    Medical condition: Malignancies carrying a genetic alteration of ALK, MET or ROS1
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DE (Trial now transitioned) IE (Completed) ES (Ongoing) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003315-35 Sponsor Protocol Number: B7461006 Start Date*: 2017-08-01
    Sponsor Name:Pfizer Inc,
    Full Title: A Phase 3, randomized, open-label study of lorlatinib (PF-06463922) monotherapy versus crizotinib monotherapy in the first-line treatment of patients with advanced ALK-positive non-small cell lung ...
    Medical condition: Advanced ALK positive non small cell lung cancer
    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
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) DK (Prematurely Ended) CZ (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000860-40 Sponsor Protocol Number: CC-220-MM-001 Start Date*: 2016-08-24
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 1B/2A Multicenter, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in ...
    Medical condition: RELAPSED AND REFRACTORY MULTIPLE MYELOMA
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10067095 Multiple myeloma progression LLT
    16.1 100000004851 10028229 Multiple myelomas HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) NL (Trial now transitioned) FR (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-002908-42 Sponsor Protocol Number: BM18249 Start Date*: 2005-11-18
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A multi-center, double-blind, randomized, placebo-controlled dose-ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of RO4389620 in patients with type 2 diabe...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    7 10012613 low
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-003562-39 Sponsor Protocol Number: ARC-10 Start Date*: 2021-10-01
    Sponsor Name:Arcus Biosciences, Inc.
    Full Title: A Phase 3 Study to Evaluate Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB154 in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-...
    Medical condition: First Line Non-Small Cell Lung Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) GR (Trial now transitioned) IE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001833-42 Sponsor Protocol Number: CRN00808-02 Start Date*: 2018-11-13
    Sponsor Name:Crinetics Pharmaceuticals, Inc.
    Full Title: A double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety, pharmacokinetics and efficacy of CRN00808 in patients with acromegaly that are responders to octreotide LAR o...
    Medical condition: Acromegaly
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10000599 Acromegaly PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) GR (Completed) PL (Completed) GB (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-004105-85 Sponsor Protocol Number: D910DC00001 Start Date*: 2019-09-25
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcin...
    Medical condition: Histologically or cytologically (or radiologically for patients undergoing curative ablation) confirmed Locoregional Hepatocellular Carcinoma (HCC) and successfully completed curative therapy (rese...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10077746 Hepatocellular carcinoma stage I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000105-36 Sponsor Protocol Number: R2810-ONC-1540 Start Date*: 2016-09-20
    Sponsor Name:Regeneron Pharmaceuticals, Inc
    Full Title: A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH – 1 (PD-1), IN PATIENTS WITH ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA
    Medical condition: Advanced cutaneous squamous cell carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012152-24 Sponsor Protocol Number: ABT4710n Start Date*: 2011-10-24
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A PHASE II, MULTICENTER, RANDOMIZED, CONTROLLED, OPEN-LABEL STUDY OF THE SAFETY, EFFICACY AND PHARMACOKINETICS OF ABT-263 IN COMBINATION WITH DOSE-INTENSIVE RITUXIMAB, OR DOSE-INTENSIVE RITUXIMAB A...
    Medical condition: B Cell Chronic Lymphocytic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008956 Chronic lymphatic leukaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011992-61 Sponsor Protocol Number: EMR200066-003 Start Date*: 2009-10-05
    Sponsor Name:Merck Serono S.A. - Geneva
    Full Title: Ensayo de fase II, aleatorizado, del inhibidor de MEK AS703026 o placebo en combinación con gemcitabina, en pacientes con cáncer de páncreas metastásico no tratados previamente con quimioterapia.
    Medical condition: Tratamiento de primera línea con AS703026 en combinación con gemcitabina del cáncer metastático de páncreas y /o tratamiento de segunda línea con AS703026 tras progresión con monoterapia de gemcita...
    Disease: Version SOC Term Classification Code Term Level
    9 10033577 Pancreas carcinoma recurrent LLT
    9 10033576 Pancreas carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) FR (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004265-39 Sponsor Protocol Number: VS-6766-202 Start Date*: 2021-08-27
    Sponsor Name:Verastem, Inc.
    Full Title: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell ...
    Medical condition: Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) 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) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) IT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-005144-42 Sponsor Protocol Number: CINC280A2X02B Start Date*: 2017-05-31
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, multi-center, global, rollover study for patients who have previously received capmatinib (INC280) as monotherapy or in combination in a Novartis Sponsored trial
    Medical condition: cMET-dependent malignancies
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Completed) DK (Completed) FR (Completed) AT (Completed) SE (Ongoing) IT (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022718-17 Sponsor Protocol Number: 1245.31 Start Date*: 2011-03-15
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A phase III double-blind, extension, placebo-controlled parallel group safety and efficacy trial of BI 10773 (10 and 25mg once daily) and sitagliptin (100mg once daily) given for minimum 76 weeks (...
    Medical condition: Type 2 Diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GR (Completed) SK (Completed) SI (Completed) BE (Completed) IE (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Jun 27 08:38:15 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA