^
    4d
    Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung (clinicaltrials.gov)
    P1, N=20, Suspended, Mayo Clinic | Trial completion date: Oct 2024 --> Jan 2026 | Withdrawn --> Suspended | Trial primary completion date: Oct 2024 --> Jan 2026
    Trial completion date • Trial suspension • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Leukine (sargramostim)
    6d
    Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov)
    P1/2, N=26, Completed, Sellas Life Sciences Group | Active, not recruiting --> Completed | N=90 --> 26
    Trial completion • Enrollment change • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PGR (Progesterone receptor) • WT1 (WT1 Transcription Factor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    HER-2 negative • KRAS wild-type • RAS wild-type • BRCA mutation • PGR negative
    |
    Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
    6d
    Using a Targeted Cancer Vaccine (Galinpepimut-S) with Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
    P1, N=10, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Nov 2024 | Trial primary completion date: Jul 2025 --> Nov 2024
    Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    WT1 (WT1 Transcription Factor)
    |
    Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
    7d
    MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial primary completion date: Jun 2023 --> Feb 2024
    Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    Zolinza (vorinostat) • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim)
    19d
    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)
    19d
    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)
    26d
    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)
    1m
    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)
    1m
    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
    1m
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    4ms
    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)
    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 | 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)
    5ms
    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)
    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 2024 --> Dec 2027
    Trial completion date • Metastases
    |
    Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
    5ms
    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)
    6ms
    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
    6ms
    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)
    7ms
    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)
    8ms
    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)
    8ms
    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)