Leukine (sargramostim) / Partner Therap 
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26 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Leukine (sargramostim) / Partner Therap
2015-003186-28: BIOSKILL: Studying Vacc-4x, an HIV therapeutic vaccine, an as-sessment of immune-mediated anti-viral effects, when administered with adjuvant GM-CSF prior to HIV latent reservoir activation by the HDAC inhibitor, romidepsin

Ongoing
2
192
Europe
Vacc-4x, Leukine, Istodax, Vacc-4x, -, Powder for solution for injection, Powder and solution for solution for injection, Leukine, Istodax
Bionor Pharma ASA, Bionor Pharma ASA
HIV infection, HIV infection, Diseases [C] - Virus Diseases [C02]
 
 
2019-002026-75: Clinical research study to investigate effectiveness and safety of UV1 Vaccination in Combination with Nivolumab and Ipilimumab as First-line Treatment of Patients with Unresectable or Metastatic Melanoma

Not yet recruiting
2
154
Europe, RoW
UV1, LEUKINE, Powder for solution for injection
Ultimovacs ASA, Ultimovacs ASA
Unresectable or Metastatic Melanoma, A melanoma not capable of being surgically removed or that has been spread to other parts of the body, Diseases [C] - Cancer [C04]
 
 
2019-002721-30: Nivolumab and ipilimumab +/- UV1 vaccination as second line treatment in patients with malignant mesothelioma (the NIPU-study)

Ongoing
2
118
Europe
Yervoy, Opdivo, UV1, Leukine, BMS-936558, Infusion, Powder and solvent for solution for injection, Yervoy (ipilimumab), Opdivo (nivolumab), Leukine
Oslo University Hospital, BMS Pharmaceuticals Ltd, Ultimovacs
Malignant pleural mesothelioma (MPM), Malignant pleural mesothelioma (MPM), Diseases [C] - Cancer [C04]
 
 
2020-005910-17: Phase II study of pembrolizumab alone or in combination with UV1 cancer vaccine in patients with recurrent or metastatic PD-L1-positive (CPS≥1) head and neck squamous cell carcinoma. Phase-II-Studie mit Pembrolizumab allein oder in Kombination mit dem UV1-Krebsimpfstoff bei Patienten mit rezidiviertem oder metastasiertem PD-L1-positivem (CPS≥1) Plattenepithelkarzinom im Kopf- Hals-Bereich

Not yet recruiting
2
75
Europe
UV-1, Powder for solution for injection, Lyophilisate for solution for injection, Leukine
Martin-Luther-Universität Halle-Wittenberg, Ultimovacs ASA
Recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Rezidiviertes oder metastasiertes Plattenepithelkarzinom des Kopf-Hals Bereiches (HNSCC), Recurrent or metastatic head and neck squamous cell carcinoma. Rezidiviertes oder metastasiertes Plattenepithelkarzinom des Kopf Hals Bereichs (HNSCC), Diseases [C] - Cancer [C04]
 
 
2020-004738-39: DOVACC.A study investigating the effect of the medication: olaparib, durvalumb and UV1 as maintenance therapy for patients with Recurrent Ovarian Cancer.

Ongoing
2
184
Europe
UV1, Imfinzi (Durvalumab), LEUKINE, Powder for solution for injection, Tablet, Infusion, Lynparza, Imfinzi, Leukine
Nordic Society of Gynaecological Oncology - Clinical Trial Unit, Ultimovacs, AstraZeneca
Ovarian cancer, Ovarian cancer, Diseases [C] - Cancer [C04]
 
 
2021-005729-25: A trial to investigate UVT vaccine in combination with standard immunotherapy treatment vs standard immunotherapy treatment alone, fortreatment of patients with non-small cell lung cancer.

Not yet recruiting
2
138
Europe
UV1, Leukine, Powder and solution for solution for injection, Leukine
Vestre Viken Health Trust, Ultimovacs
Inoperable advanced or metastatic non-small cell lung cancer (NSCLC), Inoperable advanced or metastatic non-small cell lung cancer (NSCLC), Diseases [C] - Cancer [C04]
 
 
NCI-2018-01474, NCT03600350: pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer

Active, not recruiting
2
19
US
pTVG-HP, Nivolumab, Opdivo, GM-CSF, Leukine, Sargramostim
University of Wisconsin, Madison, Bristol-Myers Squibb, Madison Vaccines Inc. (MVI), AIQ Solutions
Prostate Cancer
12/22
12/27
NCT01903330: ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme

Checkmark Interim results in combination with ERC1671/GM CSF/cyclophosphamide for recurrent glioblastoma
Aug 2020 - Aug 2020: Interim results in combination with ERC1671/GM CSF/cyclophosphamide for recurrent glioblastoma
Active, not recruiting
2
84
US
ERC1671, Gliovac, GM-CSF, Leukine®, sargramostim, Cyclophosphamide, 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, Oral Control (Sucrose pill), Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%)), Bevacizumab/Bevacizumab Biosimilar, Avastin, MVASI, bevacizumab-awwb, bevacizumab-bvzr, ZIRABEV
Epitopoietic Research Corporation, University of California, Irvine
Glioblastoma, Gliosarcoma
03/23
03/23
Conerstone3, NCT05771584: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer

Recruiting
2
24
RoW
AST-301, pNGVL3-hICD, rhuGM-CSF, Leukine, Sargramostim
Aston Sci. Inc.
Gastric Cancer
10/25
06/26
ABSCOPAL 5001, NCT04713371: A Phase 2 Trial for Patients With Metastatic Solid Cancer

Active, not recruiting
2
32
US
Keytruda Injectable Product, pembrolizumab, Yervoy Injectable Product, ipilimumab, Cytoxan, Cyclophosphamide, Cryosurgical freezing (cryosurgery), Cryoablation, GM-CSF Injectable, Sargramostim
Rampart Health, L.L.C.
Metastatic Cancer
12/24
12/24
NIPU, NCT04300244: Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma

Hourglass Jul 2022 - Dec 2022 : Top-line data from NIPU trial in combination with UV1 and Yervoy for malignant mesothelioma
Active, not recruiting
2
118
Europe, RoW
UV1 vaccine + leukine, ipilimumab, Yervoy, nivolumab, Opdivo
Åslaug Helland, Oslo University Hospital, Ultimovacs ASA, Bristol-Myers Squibb
Cancer, Cancer, Lung, Cancer of Lung, Mesothelioma, Mesothelioma; Lung, Mesothelioma; Pleura, Mesotheliomas Pleural
03/25
03/27
INITIUM, NCT04382664: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

Hourglass Jul 2022 - Dec 2022 : Top-line data from INITIUM trial in combination with UV1 and Yervoy for 1L melanoma
Completed
2
156
Europe, US
UV1, Sargramostim, Leukine, Ipilimumab, Yervoy, Nivolumab, Opdivo
Ultimovacs ASA
Malignant Melanoma
01/24
04/24
NCT04856176: A Study of Sargramostim Plus Pembrolizumab With or Without Pemetrexed in Patients With Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy

Recruiting
2
83
US
Granulocyte-Macrophage Colony-Stimulating Factor, Pembrolizumab, pemetrexed, Paclitaxel, Carboplatin
Tufts Medical Center, Partner Therapeutics, Inc.
Advanced Lung Non-Small Cell Carcinoma, Non-Small Cell Carcinoma of Lung, TNM Stage 4
12/24
12/24
SESAD, NCT04902703: Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease

Recruiting
2
42
US
Sargramostim, Leukine, Granulocyte Macrophage Colony Stimulating Factor, Saline - placebo comparator, Sterile solution of sodium chloride in water
University of Colorado, Denver, National Institute on Aging (NIA), Alzheimer's Association, Partner Therapeutics, Inc.
Alzheimer Disease
04/26
10/26
FOCUS, NCT05075122 / 2020-005910-17: Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab

Recruiting
2
75
Europe
UV1, Sargramostim for Injection, Pembrolizumab injection
Martin-Luther-Universität Halle-Wittenberg, Ultimovacs ASA, Apotheke der Universitätsmedizin der Johannes Gutenberg-Universität Mainz (Germany), Axel Hinke. CCRC Cancer Clinical Research Consulting (Düsseldorf, Germany
Head and Neck Squamous Cell Carcinoma
08/24
02/25
NCT06450041: NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

Not yet recruiting
2
62
US
Universal Donor (UD) TGFβi NK Cells, Temozolomide, Irinotecan, Dinutuximab, Unituxin, GM-CSF, Sargramostim
New Approaches to Neuroblastoma Therapy Consortium, Nationwide Children's Hospital, United Therapeutics, Children's Neuroblastoma Cancer Fund
Neuroblastoma
12/28
12/38
Cornerstone001, NCT05163223: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer

Terminated
2
10
US, RoW
AST-301(pNGVL3-hICD), AST-301, rhuGM-CSF, Leukine, Sargramostim, Placebo, Normal Saline, Pembrolizumab, Keytruda, Capecitabine, Xeloda
Aston Sci. Inc.
Breast Cancer
05/24
05/24
Cornerstone4, NCT05794659: Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer

Not yet recruiting
2
98
US
AST-201, pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine, Paclitaxel, Taxol, Carboplatin, Paraplatin, Placebo, Normal saline (USP), rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor), sargramostim, Leukine
Aston Sci. Inc.
Advanced Ovarian Cancer
11/25
11/27
NCT01789099 / 2012-001852-20: A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer.

Active, not recruiting
1/2
18
Europe
UV1 synthetic peptide vaccine and GM-CSF, UV1, Leukine
Ultimovacs ASA, Oslo University Hospital
Non-small Cell Lung Cancer
04/23
04/23
NCT01784913 / 2012-002411-26: A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer

Active, not recruiting
1/2
22
Europe
UV1 synthetic peptide vaccine and GM-CSF, UV1, Leukine
Ultimovacs ASA
Prostate Cancer
04/23
04/23
NCT02275416: Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma

Checkmark From positive 5-year overall survival data in combination with UV1 for metastatic malignant melanoma
Dec 2020 - Dec 2020: From positive 5-year overall survival data in combination with UV1 for metastatic malignant melanoma
Active, not recruiting
1/2
12
Europe
Ipilimumab, Yervoy, UV1 vaccine, UV1, GM-CSF, Leukine
Ultimovacs ASA, Oslo University Hospital
Malignant Melanoma
02/25
02/25
NCT02334865: SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy

Active, not recruiting
1
18
US
Incomplete Freund's Adjuvant, Freund's Incomplete Adjuvant, IFA, ISA-51, Montanide ISA 51, Montanide ISA-51, Laboratory Biomarker Analysis, Lenalidomide, CC-5013, CC5013, CDC 501, Revlimid, Sargramostim, 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin, SVN53-67/M57-KLH Peptide Vaccine
Roswell Park Cancer Institute, Celgene
Partial Response of Multiple Myeloma or Plasma Cell Leukemia, Plasma Cell Myeloma
09/22
05/26
NCT03332667: MIBG With Dinutuximab +/- Vorinostat

Active, not recruiting
1
45
US
131I-MIBG, 131I-Metaiodobenzylguanidine, Iobenguane sulfate, m-Iodobenzylguanidine sulfate, MIBG, Dinutuximab, Chimeric Monoclonal Antibody 14.18, MAB Ch 14.18, Unituxin, Ch14.18, Vorinostat, Zolina, Sargramostim, Potassium Iodide
New Approaches to Neuroblastoma Therapy Consortium, United Therapeutics
Neuroblastoma
06/23
06/25
NCT05475106: Pilot Study of Neoantigen Peptides and Leukine for the Treatment of Neoplasms

Recruiting
1
100
RoW
Neoantigen Peptides
Instituto de Medicina Regenerativa
Neoplasms
11/25
06/26
NCT05677633: Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease

Active, not recruiting
1
11
US
Sargramostim, Leukine
University of Nebraska, Partner Therapeutics, Inc.
Parkinson's Disease and Parkinsonism
04/24
12/24
NCT03189706: Study of Chemoimmunotherapy for High-Risk Neuroblastoma

Active, not recruiting
1
48
US
Irinotecan, temozolomide, Hu3F8, GM-CSF
Memorial Sloan Kettering Cancer Center, Y-mAbs Therapeutics
Neuroblastoma (NB)
06/25
06/25

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