Leukine (sargramostim) / Partner Therap - LARVOL DELTA

A pilot induction regimen incorporating dinutuximab and sargramostim for the treatment of newly diagnosed high-risk neuroblastoma: A report from the Children's Oncology Group. (ASCO 2022) - P2 | "Chemoimmunotherapy including irinotecan, temozolomide, DIN and sargramostim (GM-CSF) in patients with recurrent or refractory neuroblastoma results in robust objective clinical responses. The administration of DIN and GM-CSF to COG Induction Cycles 3-5 for patients with newly-diagnosed high-risk neuroblastoma was tolerable and feasible. The objective response rate at EOI appears encouraging. This therapeutic regimen will be studied in a randomized phase 3 trial to further evaluate the efficacy of Induction phase chemoimmunotherapy for high-risk neuroblastoma."

Clinical • Hypotension • Neuroblastoma • Oncology • Pain • Solid Tumor • CSF2

STING: NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (clinicaltrials.gov) - P1/2 | N=31 | Active, not recruiting | Sponsor: Nationwide Children's Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Neuroblastoma • Oncology • Solid Tumor

Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma. (PubMed, J Clin Oncol) - P2 | "SurVaxM appeared to be safe and well tolerated. The combination represents a promising therapy for nGBM. For patients with nGBM treated in this manner, PFS may be an acceptable surrogate for OS. A large randomized clinical trial of SurVaxM for nGBM is in progress."

Clinical • Journal • P2a data • Brain Cancer • CNS Tumor • Glioblastoma • Immunology • Oncology • Solid Tumor • BIRC5 • CD8

Testing the SurVaxM Vaccine for Lung Cancer Prevention (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2029 ➔ Dec 2029 | Initiation date: Jul 2026 ➔ Oct 2026

Trial completion date • Trial initiation date • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas (clinicaltrials.gov) - P2 | N=60 | Suspended | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Suspended

Trial suspension • Endocrine Cancer • Gastrointestinal Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor

Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (clinicaltrials.gov) - P1/2 | N=76 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Jul 2026 ➔ Oct 2026

Trial initiation date • Ganglioneuroblastoma • Neuroblastoma • Oncology • Solid Tumor

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University of Washington | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Nov 2032 | Trial primary completion date: Aug 2024 ➔ Nov 2027

Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ENG

Efficacy of anti-GD2 antibody immunotherapy with filgrastim and teceleukin versus standard treatment with sargramostim, aldesleukin and isotretinoin in children with high-risk neuroblastoma. (PubMed, Int J Clin Oncol) - "Our results suggest that the efficacy of the alternative regimen containing G-CSF is comparable to that of the ANBL0032 regimen, providing a rationale for further evaluation in a phase III trial."

Journal • Hematological Disorders • Infectious Disease • Neuroblastoma • Oncology • Solid Tumor • Transplantation • CSF2

Conerstone3: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Aston Sci. Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ May 2027 | Trial primary completion date: Oct 2025 ➔ Feb 2027

Enrollment closed • Trial completion date • Trial primary completion date • Gastric Cancer • Oncology • Solid Tumor • HER-2

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Steven DuBois, MD | Trial primary completion date: Dec 2026 ➔ Jul 2027

Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor

Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

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 | Suspended | Sponsor: University of California, Davis | Trial completion date: Jan 2030 ➔ Jan 2034 | Recruiting ➔ Suspended | Trial primary completion date: Jan 2026 ➔ Dec 2030

Trial completion date • Trial primary completion date • Trial suspension • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • NTRK • ROS1

A Marked Improvement in Mild but Progressive Autoimmune Pulmonary Alveolar Proteinosis Treated with Inhaled Granulocyte-Macrophage Colony-Stimulating Factor Therapy: A Case Report. (PubMed, Intern Med) - "After 6 months, a marked improvement was observed, and the alveolar-arterial oxygen difference decreased from 21.8 to 1.1 mmHg. Given the limited evidence in milder cases, this report suggests that early intervention with inhaled sargramostim may be effective in relatively mild but progressive aPAP."

Journal • Immunology • Respiratory Diseases • CSF2

Diagnostic and Therapeutic Dilemmas in Recurrent Pulmonary Alveolar Proteinosis After Bilateral Lung Transplantation. (PubMed, Respirol Case Rep) - "Ultimately, repeat lavage revealed PAS-positive lipoproteinaceous material, and treatment with inhaled sargramostim plus two sequential WLLs produced marked radiographic clearance, symptomatic relief and partial spirometric recovery. Our case highlights how multimodal, longitudinal clinical surveillance remains essential in lung transplant recipients."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Transplantation • CSF2

Characterization of the Sequence of Cytopenia after Total-body Irradiation using Unsupervised Machine Learning. (PubMed, Radiat Res) - "This study aimed to characterize the sequence of pancytopenia after TBI in male and female non-human primates (NHPs) with and without sargramostim treatment using unsupervised machine learning (ML)...Female NHPs generally experienced deeper nadirs than males. In summary, characterizing pancytopenia using unsupervised machine learning improves understanding of the pathogenesis of H-ARS, which can enable improved therapeutic care, countermeasure development, and efficient medical triage."

Journal • Hematological Disorders

Comorbidity of autoimmune diseases in patients with autoimmune pulmonary alveolar proteinosis. (PubMed, Respir Investig) - "In patients with autoimmune diseases, APAP at its onset can be misdiagnosed as other pulmonary diseases, specifically interstitial lung disease. The use of immunosuppressive drugs may be associated with worsening APAP."

Journal • Autoimmune Hepatitis • Dermatology • Dermatomyositis • Giant Cell Arteritis • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Interstitial Lung Disease • Musculoskeletal Pain • Myositis • Pain • Pneumonia • Psoriasis • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Thrombocytopenia • Thrombocytopenic Purpura

NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - P2 | N=42 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Mar 2026

Trial completion • Trial completion date • Ganglioneuroblastoma • Neuroblastoma • Oncology • Solid Tumor • MYCN

GPAD-3: Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease (clinicaltrials.gov) - P2 | N=151 | Completed | Sponsor: Emory University | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jul 2025 | Trial primary completion date: Dec 2025 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Peripheral Arterial Disease • CXCR4

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 | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: May 2026 ➔ Dec 2026

Trial completion date • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

GRACE: GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study (clinicaltrials.gov) - P4 | N=75 | Completed | Sponsor: Nationwide Children's Hospital | Active, not recruiting ➔ Completed | N=120 ➔ 75

Enrollment change • Trial completion • Infectious Disease • Pediatrics • Septic Shock

Efficacy and Safety of Inhaled GM-CSF in Autoimmune Pulmonary Alveolar Proteinosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. (PubMed, Lung) - "Inhaled GM-CSF improves gas exchange, oxygenation, and dyspnea in aPAP while maintaining a favorable safety profile, indicating its potential as a noninvasive, targeted therapy."

Clinical • Journal • Retrospective data • Review • Immunology • Pulmonary Disease • Respiratory Diseases • CSF2

Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2026 ➔ Apr 2027

Trial completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Testing the SurVaxM Vaccine for Lung Cancer Prevention (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2027 ➔ Sep 2029 | Initiation date: Feb 2026 ➔ Jun 2026 | Trial primary completion date: Sep 2027 ➔ Mar 2029

Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - P2 | N=153 | Completed | Sponsor: St. Jude Children's Research Hospital | Active, not recruiting ➔ Completed

Trial completion • Neuroblastoma • Oncology • Solid Tumor • MYCN