^
    8d
    Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease (clinicaltrials.gov)
    P1, N=11, Completed, University of Nebraska | Active, not recruiting --> Completed
    Trial completion
    |
    Leukine (sargramostim)
    8d
    NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (clinicaltrials.gov)
    P2, N=62, Recruiting, New Approaches to Neuroblastoma Therapy Consortium | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
    15d
    Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients with Metastatic Melanoma to the Lung (clinicaltrials.gov)
    P1, N=0, Withdrawn, Mayo Clinic | N=24 --> 0 | Trial completion date: Jul 2025 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2025 --> Oct 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Leukine (sargramostim)
    23d
    ANBL19P1: 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=41, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date • Combination therapy
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    28d
    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: Sep 2024 --> Sep 2025
    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
    28d
    GM-CSF With Post-Transplant Cyclophosphamide (clinicaltrials.gov)
    P2, N=38, Recruiting, Northside Hospital, Inc. | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial primary completion date • Post-transplantation
    |
    cyclophosphamide • Leukine (sargramostim)
    1m
    Tebentafusp-tebn With LDT in Metastatic UM (clinicaltrials.gov)
    P1/2, N=109, Not yet recruiting, Thomas Jefferson University
    New P1/2 trial
    |
    carmustine • Kimmtrak (tebentafusp-tebn) • Leukine (sargramostim)
    1m
    Biomarker Assessments of Leukine During Treatment of Parkinson's Disease (clinicaltrials.gov)
    P1, N=7, Completed, University of Nebraska | Active, not recruiting --> Completed
    Trial completion
    |
    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 2025 --> Oct 2026 | Trial primary completion date: Jul 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    Leukine (sargramostim)
    2ms
    WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation (clinicaltrials.gov)
    P1/2, N=20, Completed, Sellas Life Sciences Group | Unknown status --> Completed | Phase classification: PN/A --> P1/2
    Trial completion • Phase classification
    |
    WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule)
    |
    WT1 expression • WT1 positive
    |
    lenalidomide • bortezomib • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
    2ms
    WOKVAC: Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission (clinicaltrials.gov)
    P1, N=32, Completed, University of Washington | Active, not recruiting --> Completed | N=24 --> 32
    Trial completion • Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative • HER-2 expression
    |
    Leukine (sargramostim)
    2ms
    MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Jun 2024 --> Jun 2025
    Trial completion date
    |
    CD34 (CD34 molecule)
    |
    Zolinza (vorinostat) • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim)
    3ms
    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 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    WT1 (WT1 Transcription Factor)
    |
    Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
    3ms
    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 | Trial completion date: Jan 2028 --> Oct 2028 | Initiation date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jan 2027 --> Oct 2027
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    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: Apr 2025 --> Jul 2025 | Trial primary completion date: Apr 2025 --> Jul 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Leukine (sargramostim)
    4ms
    N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma (clinicaltrials.gov)
    P2, N=45, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial
    |
    carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • irinotecan • vincristine • topotecan • Danyelza (naxitamab-gqgk) • Leukine (sargramostim)
    4ms
    Metastatic Solid Cancer Clinical Trial (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, ImmunSYS, LLC | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • Leukine (sargramostim)
    4ms
    Conerstone3: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (clinicaltrials.gov)
    P2, N=24, Recruiting, Aston Sci. Inc. | Trial primary completion date: Oct 2023 --> Oct 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    AST-301 • Leukine (sargramostim)
    4ms
    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 2024 --> Dec 2027
    Trial completion date • Metastases
    |
    Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
    4ms
    Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov)
    P1, N=48, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Phase classification: P2 --> P1 | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Phase classification • Trial completion date • Trial primary completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    temozolomide • irinotecan • Danyelza (naxitamab-gqgk) • Leukine (sargramostim)
    5ms
    Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, University of Nebraska | Trial completion date: May 2024 --> Dec 2024
    Trial completion date
    |
    Leukine (sargramostim)
    5ms
    Cornerstone001: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=10, Terminated, Aston Sci. Inc. | N=146 --> 10 | Trial completion date: Dec 2025 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> May 2024; Difficulty in recruiting patients
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • capecitabine • AST-301 • Leukine (sargramostim)
    5ms
    PNeoVCA: Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=36, Recruiting, Mayo Clinic | Phase classification: P1 --> P1/2
    Phase classification • 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)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • Leukine (sargramostim) • neoantigen peptide vaccine
    5ms
    NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (clinicaltrials.gov)
    P2, N=62, Not yet recruiting, New Approaches to Neuroblastoma Therapy Consortium
    New P2 trial • Combination therapy
    |
    temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
    6ms
    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)
    7ms
    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)
    7ms
    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)
    7ms
    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)
    7ms
    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)
    7ms
    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
    7ms
    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
    7ms
    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)
    7ms
    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)
    7ms
    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)
    8ms
    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)
    8ms
    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)
    9ms
    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
    9ms
    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)
    9ms
    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)
    9ms
    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)
    9ms
    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)
    10ms
    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