^
    17h
    Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, University of Nebraska
    Trial completion date • Trial primary completion date
    |
    Leukine (sargramostim)
    11d
    Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P2, N=132, Not yet recruiting, Roswell Park Cancer Institute | Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date • Metastases
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    19d
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    19d
    Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2024 --> Apr 2025
    Trial completion date • Surgery
    |
    Leukine (sargramostim) • Panvac-VF (falimarev/inalimarev)
    21d
    Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma (clinicaltrials.gov)
    P2, N=24, Completed, Fundació Sant Joan de Déu | Unknown status --> Completed
    Trial completion
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    Unituxin (dinutuximab) • Leukine (sargramostim)
    26d
    INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov)
    P2, N=156, Completed, Ultimovacs ASA | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Apr 2024 | Trial primary completion date: Apr 2024 --> Jan 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
    27d
    NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Sep 2024
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
    |
    MYCN amplification • IL6 expression
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
    29d
    GM-CSF With Post-Transplant Cyclophosphamide (clinicaltrials.gov)
    P2, N=38, Recruiting, Northside Hospital, Inc. | Trial completion date: May 2025 --> Sep 2025 | Trial primary completion date: May 2024 --> Sep 2024
    Trial completion date • Trial primary completion date • Post-transplantation
    |
    cyclophosphamide • Leukine (sargramostim)
    1m
    SESAD: Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (clinicaltrials.gov)
    P2, N=42, Recruiting, University of Colorado, Denver | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    Leukine (sargramostim)
    1m
    Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P2, N=245, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date • Surgery • Metastases
    |
    Yervoy (ipilimumab) • Leukine (sargramostim)
    2ms
    SLSG18-301: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov)
    P3, N=126, Active, not recruiting, Sellas Life Sciences Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S) • hydroxyurea • Leukine (sargramostim)
    2ms
    STEMVAC in Patients With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=33, Recruiting, University of Washington | Trial completion date: Apr 2024 --> Dec 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma)
    |
    HER-2 negative • HER-2 expression • PGR expression
    |
    EP-101 STEMVAC • Leukine (sargramostim)
    2ms
    NIPU: Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (clinicaltrials.gov)
    P2, N=118, Active, not recruiting, Åslaug Helland | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial primary completion date • Tumor mutational burden
    |
    TMB (Tumor Mutational Burden)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
    2ms
    Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
    P2, N=95, Active, not recruiting, Children's Oncology Group | Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CD276 (CD276 Molecule) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    2ms
    NCI-2015-00694: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date
    |
    HLA-A*11 • HLA-A*24
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    3ms
    STING: NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (clinicaltrials.gov)
    P1/2, N=31, Recruiting, Nationwide Children's Hospital | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
    3ms
    Sargramostim for Prophylactic Management of Gastrointestinal Immune-Related Adverse Events of Immune Checkpoint Inhibitor Therapy for Cancer. (PubMed, Cancers (Basel))
    In a prospective, randomized study (ECOG 1608), advanced melanoma patients had a reduction in grade 3-5 GI irAEs and less frequent colonic perforation in the sargramostim plus ipilimumab arm compared to ipilimumab alone. Sargramostim continues to be studied with ICIs for the prophylactic management of irAEs while also potentially providing a survival benefit.
    Review • Journal • Adverse events • Checkpoint inhibition
    |
    CSF2 (Colony stimulating factor 2)
    |
    Yervoy (ipilimumab) • Leukine (sargramostim)
    4ms
    PNeoVCA: Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Mayo Clinic | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    TMB-H
    |
    Keytruda (pembrolizumab) • cyclophosphamide • Leukine (sargramostim) • neoantigen peptide vaccine
    4ms
    A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, University of Washington | Trial completion date: Jan 2026 --> Dec 2026 | Trial primary completion date: Jan 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    CD4 (CD4 Molecule)
    |
    EP-101 STEMVAC • Leukine (sargramostim)
    4ms
    Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
    P2, N=153, Active, not recruiting, St. Jude Children's Research Hospital | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • humanised dinutuximab (Hu14.18K322A)
    4ms
    Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Mayo Clinic | Trial completion date: Jan 2025 --> Apr 2025 | Initiation date: Dec 2023 --> Mar 2024 | Trial primary completion date: Jan 2025 --> Apr 2025
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Leukine (sargramostim)
    4ms
    Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P2, N=132, Not yet recruiting, Roswell Park Cancer Institute
    New P2 trial • Metastases
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    4ms
    A Study of Sargramostim Plus Pembrolizumab With or Without Pemetrexed in Patients With Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy (clinicaltrials.gov)
    P2, N=83, Recruiting, Tufts Medical Center
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • Leukine (sargramostim)
    5ms
    Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P1, N=14, Recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim) • octreotide acetate
    5ms
    GM-CSF, G-CSF or no cytokine therapy with anti-GD2 immunotherapy for high-risk neuroblastoma. (PubMed, Int J Cancer)
    This comprehensive review summarizes clinical data regarding efficacy and safety of GM-CSF, recombinant human granulocyte colony-stimulating factor (G-CSF) or no cytokine in combination with anti-GD2 monoclonal antibodies (ie, dinutuximab, dinutuximab beta or naxitamab) for immunotherapy of patients with high-risk neuroblastoma...Suboptimal efficacy outcomes with G-CSF raise concerns about its suitability as an alternative to GM-CSF as an adjuvant in immunotherapy for patients with high-risk neuroblastoma. While programs exist to facilitate obtaining GM-CSF and anti-GD2 monoclonal antibodies in regions where they are not commercially available, continued work is needed to ensure equitable therapeutic options are available globally.
    Review • Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    Qarziba (dinutuximab beta) • Danyelza (naxitamab) • Leukine (sargramostim)
    5ms
    NCI-2018-01474: pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Nov 2023 --> Nov 2024
    Trial completion date • Metastases
    |
    Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
    5ms
    VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=43, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> May 2023
    Trial completion • Trial completion date
    |
    HLA-A2 positive
    |
    HER-2/neu peptide vaccine • Leukine (sargramostim) • NeuVax (nelipepimut-S)
    5ms
    Intermittent Sargramostim Administration Expands Proliferating Naïve T Cells, Tregs, HLA-DR+ PD-L1+ Monocytes and Myeloid-Derived Suppressor Cells: Results from a Randomized Placebo-Controlled Clinical Trial of GM-CSF in Patients with Peripheral Artery Disease (ASH 2023)
    Our findings demonstrate that intermittent dosing with sargramostim is well-tolerated and induces significant but transient increases in the numbers and activation status of T cells in the bloodstream. Sargramostim treatment also increased numbers of proliferating naïve T cells, Tregs, and certain subsets of myelo-monocytic cells with immunosuppressive phenotypes. These results support the use of intermittent sargramostim dosing to avoid excessive leukocytosis and associated adverse effects.
    Clinical
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL2RA (Interleukin 2 receptor, alpha) • CD14 (CD14 Molecule) • CSF2 (Colony stimulating factor 2) • FOXP3 (Forkhead Box P3)
    |
    PD-1 expression • CD8 expression • CD4 expression
    |
    Leukine (sargramostim)
    6ms
    Biomarker Assessments of Leukine During Treatment of Parkinson's Disease (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, University of Nebraska | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial primary completion date
    |
    Leukine (sargramostim)
    6ms
    Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, University of Nebraska | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Leukine (sargramostim)
    6ms
    Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome (clinicaltrials.gov)
    P2, N=42, Recruiting, University of Colorado, Denver | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Leukine (sargramostim)
    6ms
    INITIUM: UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma (clinicaltrials.gov)
    P2, N=154, Active, not recruiting, Ultimovacs ASA | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jan 2026 | Trial primary completion date: Jun 2023 --> Apr 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
    7ms
    Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma (clinicaltrials.gov)
    P2, N=41, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    7ms
    GPAD-3: Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease (clinicaltrials.gov)
    P2, N=176, Recruiting, Emory University | Trial completion date: Sep 2023 --> Oct 2024 | Trial primary completion date: Sep 2023 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    Leukine (sargramostim)
    7ms
    Early Salvage Chemo-Immunotherapy with Irinotecan, Temozolomide and Naxitamab Plus GM-CSF (HITS) for Patients with Primary Refractory High-Risk Neuroblastoma Provide the Best Chance for Long-Term Outcomes. (PubMed, Cancers (Basel))
    We investigated the combination of humanized anti-GD2 mAb naxitamab (Hu3F8), irinotecan (I), temozolomide (T), and sargramostim (GM-CSF)-HITS-against primary resistant HR-NB. Cohort 1 had a 3-year OS of 84.8% and EFS 54.4%, which are statistically significant improvements (EFS p = 0.0041 and OS p = 0.0037) compared to cohort 2. In conclusion, naxitamab-based chemo-immunotherapy is effective against primary chemo-resistant HR-NB, increasing long-term outcomes when administered early during the course of treatment.
    Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    irinotecan • Danyelza (naxitamab) • Leukine (sargramostim)
    7ms
    A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=77, Recruiting, Tianhong Li | Phase classification: P1 --> P1/2 | N=10 --> 77 | Trial completion date: Sep 2027 --> Jan 2030 | Trial primary completion date: Sep 2023 --> Jan 2026
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • MET mutation
    |
    Keytruda (pembrolizumab) • Labvax 3(22)-23 • Leukine (sargramostim)
    7ms
    Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
    P3, N=724, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • carboplatin • Lorbrena (lorlatinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • thiotepa • Qarziba (dinutuximab beta) • busulfan • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • dexrazoxane
    7ms
    Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, Children's Oncology Group | Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Jun 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    8ms
    A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma (clinicaltrials.gov)
    P2/3, N=600, Recruiting, National Cancer Institute (NCI) | Trial completion date: Aug 2023 --> Jun 2033 | Trial primary completion date: Aug 2023 --> Jun 2033
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF wild-type
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar) • Leukine (sargramostim)
    8ms
    Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=48, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    temozolomide • irinotecan • Danyelza (naxitamab) • Leukine (sargramostim)
    9ms
    Clinical Activity of Combined Telomerase Vaccination and Pembrolizumab in Advanced Melanoma: Results from a Phase I Trial. (PubMed, Clin Cancer Res)
    Encouraging safety and preliminary efficacy were observed. Randomized phase II trials are currently ongoing.
    P1 data • Journal • Metastases
    |
    CSF2 (Colony stimulating factor 2)
    |
    Keytruda (pembrolizumab) • Leukine (sargramostim) • UV1
    10ms
    Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    WT1 (WT1 Transcription Factor)
    |
    Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)