- |||||||||| Zeltherva (galinpepimut-S) / SELLAS Life Sciences
Trial completion date, Trial primary completion date, Checkpoint inhibition: Using a Targeted Cancer Vaccine (Galinpepimut-S) with Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov) - Aug 2, 2023 P1, N=10, Active, not recruiting, Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Dec 2023 Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
- |||||||||| Leukine (sargramostim) / Partner Therap, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma (clinicaltrials.gov) - Jul 10, 2023 P2/3, N=600, Recruiting, Modifying the 'immune-milieu' following allogeneic HCT is feasible and may influence long-term T-cell recovery. Trial completion date: Jun 2033 --> Aug 2023 | Trial primary completion date: Jun 2033 --> Aug 2023
- |||||||||| Leukine (sargramostim) / Partner Therap
GM-CSF Treatment Increases the Number of Purkinje Cells in a Mouse Model of Down Syndrome (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_7785; Our results suggest that treatment with GM-CSF improves cellular abnormalities by increasing the number of purkinje cells in the cerebellum of Dp16 mice. Taken together with our previous results, these findings provide further evidence that GM-CSF/sargramostim may have therapeutic benefits in people with DS.
- |||||||||| Leukine (sargramostim) / Partner Therap
GM-CSF Treatment Increases the Number of Purkinje Cells in a Mouse Model of Down Syndrome (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_5719; Our results suggest that treatment with GM-CSF improves cellular abnormalities by increasing the number of purkinje cells in the cerebellum of Dp16 mice. Taken together with our previous results, these findings provide further evidence that GM-CSF/sargramostim may have therapeutic benefits in people with DS.
- |||||||||| Leukine (sargramostim) / Partner Therap
GM-CSF Treatment Increases the Number of Purkinje Cells in a Mouse Model of Down Syndrome (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_3473; Our results suggest that treatment with GM-CSF improves cellular abnormalities by increasing the number of purkinje cells in the cerebellum of Dp16 mice. Taken together with our previous results, these findings provide further evidence that GM-CSF/sargramostim may have therapeutic benefits in people with DS.
- |||||||||| Leukine (sargramostim) / Partner Therap
GM-CSF Treatment Increases the Number of Purkinje Cells in a Mouse Model of Down Syndrome (Virtual) - Jul 6, 2023 - Abstract #AAIC2023AAIC_1253; Our results suggest that treatment with GM-CSF improves cellular abnormalities by increasing the number of purkinje cells in the cerebellum of Dp16 mice. Taken together with our previous results, these findings provide further evidence that GM-CSF/sargramostim may have therapeutic benefits in people with DS.
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion, Phase classification: FARM7MCPK4: Inhaled GM-CSF Therapy of Autoimmune PAP (clinicaltrials.gov) - Jun 26, 2023 P2, N=18, Completed, Initiation date: Jun 2023 --> Dec 2023 Unknown status --> Completed | Phase classification: P2/3 --> P2
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Enrollment change, Trial withdrawal, Metastases: Sargramostim (GM-CSF) + PD-1 (clinicaltrials.gov) - May 22, 2023 P2, N=0, Withdrawn, Trial completion date: Nov 2023 --> May 2026 | Trial primary completion date: Apr 2023 --> Sep 2022 N=30 --> 0 | Recruiting --> Withdrawn
- |||||||||| A randomized trial of olaparib, durvalumab, and cancer vaccine, UV1, as maintenance therapy in patients with BRCAwt with recurrent ovarian cancer: ENGOT-OV56/NSGO-CTU-DOVACC trial. (On Demand | Hall A; Poster Bd # 308b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2255;
P2 The following cooperative groups are participating: NSGO-CTU (DK, FIN, NOR, SWE, LTU), BGOG (BE), HeGOG (GRC, CYP), NOGGO (DE), AGO-A (AUT) & DGOG (NL). Clinical trial information: NCT04742075.
- |||||||||| Recentin (cediranib) / AstraZeneca
Trial completion date, Trial primary completion date, Monotherapy, Metastases: Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (clinicaltrials.gov) - Apr 24, 2023 P2, N=34, Active, not recruiting, Clinical trial information: NCT04742075. Trial completion date: Apr 2023 --> Mar 2024 | Trial primary completion date: Apr 2023 --> Mar 2024
- |||||||||| Leukine (sargramostim) / Partner Therap
Preclinical, Journal: Treatment with Granulocyte-Macrophage Colony-Stimulating Factor Reduces Viral Titers in the Brains of West Nile Virus-Infected Mice and Improves Survival. (Pubmed Central) - Apr 3, 2023 Recombinant human GM-CSF (rHuGMCSF) (sargramostim [Leukine]) is an FDA-approved drug used to increase white blood cells following leukopenia-inducing chemotherapy or bone marrow transplantation...Currently, there are no human vaccines or specific antivirals against WNV infections, so further research into potential new therapeutic agents is critical. This study presents a novel treatment option for WNV infections using GM-CSF and lays the foundation for further studies into the use of GM-CSF as a treatment for WNV encephalitis as well as a potential treatment for other viral infections.
- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed, Combination therapy: 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) - Mar 31, 2023 P2, N=45, Active, not recruiting, This study presents a novel treatment option for WNV infections using GM-CSF and lays the foundation for further studies into the use of GM-CSF as a treatment for WNV encephalitis as well as a potential treatment for other viral infections. Suspended --> Active, not recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
A Challenging Case of Refractory Pulmonary Alveolar Proteinosis (Walter E. Washington Convention Center, Area E, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_7649; Further studies are needed to determine the dosing and more important, the safety of these medications in our patients. On occasion, it can cause acute respiratory failure and lung transplantation is necessary.
- |||||||||| Leukine (sargramostim) / Partner Therap, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Repeated Whole Lung Lavage With Extracorporeal Membrane Oxygenation Assistance and Multimodal Medical Therapy in Severe Pulmonary Alveolar Proteinosis (Walter E. Washington Convention Center, Area A, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_4595; While whole lung lavage remains the gold standard treatment for PAP, rituximab and sargramostim are promising treatments under investigation, especially in cases of severe pulmonary alveolar proteinosis with refractory hypoxemia in spite of multiple whole lung lavage. When this rare disease is ultimately diagnosed, multimodal therapy, such as presented in this case, may be warranted to prevent worsening respiratory failure and recurrence of disease.
- |||||||||| Leukine (sargramostim) / Partner Therap, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma (clinicaltrials.gov) - Mar 22, 2023 P2/3, N=600, Recruiting, Anti-GM-CSF IgG and IgA are biomarkers associated with risk of developing disease complications in recently diagnosed CD patients. Trial completion date: Nov 2023 --> Jun 2033 | Trial primary completion date: Nov 2023 --> Jun 2033
- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial suspension, Combination therapy: 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) - Mar 20, 2023 P2, N=45, Suspended, Trial completion date: Nov 2023 --> Jun 2033 | Trial primary completion date: Nov 2023 --> Jun 2033 Active, not recruiting --> Suspended
- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date: NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - Mar 14, 2023 P2, N=42, Active, not recruiting, Active, not recruiting --> Suspended Trial completion date: Jan 2023 --> Dec 2023
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Azedra (iobenguane I 131) / Lantheus, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed: MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov) - Mar 14, 2023 P1, N=45, Active, not recruiting, Trial completion date: Jan 2023 --> Dec 2023 Recruiting --> Active, not recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap
Review, Journal, IO biomarker: Utility of monocyte HLA-DR and rationale for therapeutic GM-CSF in sepsis immunoparalysis. (Pubmed Central) - Feb 24, 2023 In particular, sargramostim, a recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF), has demonstrated clinical benefit by reducing hospitalization duration and lowering secondary infection risk...Although mHLA-DR has shown promising utility for identifying sepsis immunoparalysis, absence of a standardized, analytically validated method has thus far prevented widespread adoption. A clinically useful approach for patient inclusion and identification of clinically correlated output parameters could address the persistent high unmet medical need for effective targeted therapies in sepsis.
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Trial primary completion date: GRACE: GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study (clinicaltrials.gov) - Feb 8, 2023 P4, N=120, Active, not recruiting, A clinically useful approach for patient inclusion and identification of clinically correlated output parameters could address the persistent high unmet medical need for effective targeted therapies in sepsis. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Zeltherva (galinpepimut-S) / SELLAS Life Sciences
Enrollment open, Trial completion date, Trial primary completion date, Monotherapy: REGAL: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov) - Feb 1, 2023 P3, N=140, Recruiting, Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023 Unknown status --> Recruiting | Trial completion date: Apr 2022 --> Mar 2025 | Trial primary completion date: Dec 2021 --> Dec 2024
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