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Clinical trials for Sacituzumab

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   43861   clinical trials with a EudraCT protocol, of which   7284   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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    20 result(s) found for: Sacituzumab. Displaying page 1 of 1.
    EudraCT Number: 2019-000579-18 Sponsor Protocol Number: IMMU-132-11 Start Date*: 2022-05-30
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors
    Medical condition: Metastatic Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002964-29 Sponsor Protocol Number: IMMU-132-13 Start Date*: 2021-10-12
    Sponsor Name:Gilead Sciences Inc
    Full Title: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer
    Medical condition: Metastatic or Locally Advanced Unresectable Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10077840 Urothelial cancer of renal pelvis LLT
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    20.0 100000004864 10046723 Urothelial carcinoma ureter LLT
    20.0 100000004864 10046728 Urothelial carcinoma urethra LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing) PT (Completed) BE (Ongoing) AT (Ongoing) IT (Ongoing) IE (Ongoing) HU (Completed) BG (Ongoing) CZ (Completed) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004868-22 Sponsor Protocol Number: IMMU-132-14 Start Date*: 2020-07-31
    Sponsor Name:Immunomedics, Inc.
    Full Title: Open-label Rollover Study to Evaluate Long-Term Safety in Subjects with Metastatic Solid Tumors that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan.
    Medical condition: Metastatic Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000836-49 Sponsor Protocol Number: MK-3475-D46 Start Date*: 2023-01-16
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-...
    Medical condition: First-line treatment of metastatic programmed cell death ligand 1 expressing (tumor proportion score ≥50%) non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10029514 Non-small cell lung cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) GR (Ongoing) LT (Trial now transitioned) IT (Ongoing) LV (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004844-27 Sponsor Protocol Number: SURE-01 Start Date*: 2021-06-01
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: SURE-01_An open label, single-arm, phase 2 study of neoadjuvant sacituzumab govitecan, before radical cystectomy, for patients with muscle-invasive bladder cancer who cannot receive or refuse cispl...
    Medical condition: Muscle-invasive bladder cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10007293 Carcinoma bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004201-33 Sponsor Protocol Number: IMMU-132-09 Start Date*: 2019-08-16
    Sponsor Name:Immunomedics, Inc.
    Full Title: Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Nega...
    Medical condition: Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006198 Breast cancer recurrent PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) NL (Completed) ES (Ongoing) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004876-16 Sponsor Protocol Number: SURE-02 Start Date*: 2021-11-10
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: SURE-02_An open label, single-arm, phase 2 study of perioperative pembrolizumab plus sacituzumab govitecan for patients with muscle-invasive bladder cancer who cannot receive or refuse cisplatin-ba...
    Medical condition: muscle-invasive bladder cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-001397-61 Sponsor Protocol Number: MedOPP445 Start Date*: 2022-11-22
    Sponsor Name:Medica Scientia Innovation Research SL.
    Full Title: Multicenter, Open-label,Single arm,Phase II Clinical Trial to Improve Sacituzumab Govitecan Tolerance in Patients with Metastatic Triple-Negative Breast Cancer.–The PRIMED Study–
    Medical condition: Advanced triple-negative breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003019-21 Sponsor Protocol Number: IMMU-132-05 Start Date*: 2017-12-14
    Sponsor Name:Immunomedics, Inc.
    Full Title: An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who R...
    Medical condition: Relapsed/Refractory Triple-Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006198 Breast cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Prematurely Ended) DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-005743-79 Sponsor Protocol Number: GS-US-592-6238 Start Date*: 2022-10-31
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Nega...
    Medical condition: Programmed cell death ligand 1 (PD-L1) negative metastatic triple-negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer previously treated with an anti-PD-(L)1 agent in ...
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10084066 Triple negative breast cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) HU (Ongoing) NL (Ongoing) AT (Ongoing) PL (Ongoing) CZ (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005742-14 Sponsor Protocol Number: GS-US-592-6173 Start Date*: 2022-09-02
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, ...
    Medical condition: Programmed cell death ligand 1 (PD-L1) negative metastatic triple negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer previously treated with an anti-PD-(L)1 agent in ...
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004864 10084066 Triple negative breast cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Ongoing) IT (Ongoing) AT (Ongoing) HU (Ongoing) NL (Ongoing) CZ (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003578-30 Sponsor Protocol Number: GS-US-577-6153 Start Date*: 2022-02-25
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on o...
    Medical condition: 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) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) AT (Ongoing) DE (Ongoing) IT (Ongoing) PT (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004280-27 Sponsor Protocol Number: GS-US-576-6220 Start Date*: 2022-03-28
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non−Small-Cell Lung Cancer (NSCLC) Without Actionable...
    Medical condition: 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) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Ongoing) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004100-35 Sponsor Protocol Number: GBG102-SASCIA Start Date*: 2020-10-09
    Sponsor Name:GBG Forschungs GmbH
    Full Title: Phase III postneoadjuvant study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treat...
    Medical condition: HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061020 Breast cancer male PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006198 Breast cancer recurrent PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006199 Breast cancer stage I PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006200 Breast cancer stage II PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) IE (Ongoing) ES (Ongoing) AT (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001167-23 Sponsor Protocol Number: IMMU-132-06 Start Date*: 2019-03-20
    Sponsor Name:Immunomedics, Inc.
    Full Title: A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy
    Medical condition: Histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract predominant
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10077840 Urothelial cancer of renal pelvis LLT
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    20.0 100000004864 10046723 Urothelial carcinoma ureter LLT
    20.0 100000004864 10046728 Urothelial carcinoma urethra LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Trial now transitioned) ES (Ongoing) GR (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003669-36 Sponsor Protocol Number: MS100070_0119 Start Date*: 2022-09-13
    Sponsor Name:Merck Healthcare KGaA
    Full Title: A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination with Other Anti-Tumor Agents as a Maintenance Treatment in Participants with L...
    Medical condition: Advanced or metastatic urothelial carcinoma whose disease did not progress with 1L platinum-containing chemotherapy.
    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 Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) FR (Ongoing) DK (Ongoing) GR (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002038-21 Sponsor Protocol Number: CO40115 Start Date*: 2018-05-01
    Sponsor Name:F. Hoffman-La Roche Ltd.
    Full Title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC TRIPLE-NEGATI...
    Medical condition: Triple-negative breast cancer (TNBC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Ongoing) FR (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004634-28 Sponsor Protocol Number: WO39613 Start Date*: 2019-07-11
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN CISPLATIN-INELIGIBLE PATIENTS WITH LOC...
    Medical condition: Urothelial carcinoma (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) ES (Ongoing) GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001267-21 Sponsor Protocol Number: BO39610 Start Date*: 2018-01-25
    Sponsor Name:F. Hoffman-La Roche Ltd.
    Full Title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC NONSMALL CEL...
    Medical condition: Metastatic 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: GB (GB - no longer in EU/EEA) ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006804-34 Sponsor Protocol Number: CYP003 Start Date*: 2022-09-27
    Sponsor Name:Cytovation ASA
    Full Title: A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squam...
    Medical condition: Advanced or metastatic: -Head and Neck Squamous Cell Carcinoma (HNSCC); -Melanoma; -Triple-Negative Breast Cancer (TNBC);
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    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: ES (Ongoing) NL (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
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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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