- |||||||||| Kimmtrak (tebentafusp-tebn) / Immunocore
Trial completion date, Trial initiation date, Trial primary completion date: Tebentafusp-tebn With LDT in Metastatic UM (clinicaltrials.gov) - Feb 11, 2025 P1/2, N=109, Not yet recruiting, Trial completion date: Dec 2024 --> Jun 2025 Trial completion date: Aug 2026 --> Feb 2027 | Initiation date: Oct 2024 --> Apr 2025 | Trial primary completion date: Jul 2026 --> Jan 2027
- |||||||||| Leukine (sargramostim) / Partner Therap
Biomarker, Journal: Biomarkers. (Pubmed Central) - Jan 12, 2025 CLINICAL TRIAL REGISTRATION: Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial II registered to Japan Registry of Clinical Trials (jRCTs031220127). These findings suggest that age-associated exponential increases in neurodegeneration may underlie the contribution of aging to cognitive decline, including in AD, and that GM-CSF/sargramostim treatment may halt these effects.
- |||||||||| Leukine (sargramostim) / Partner Therap, SurVaxM (SVN53-67/M57-KLH peptide vaccine) / MimiVax
Trial completion date, Trial primary completion date, Metastases: Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (clinicaltrials.gov) - Dec 18, 2024 P1, N=14, Recruiting, N=83 --> 5 | Recruiting --> Terminated; Futility Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
- |||||||||| Zeltherva (galinpepimut-S) / SELLAS Life Sciences
Trial completion, Trial completion date, Trial primary completion date, Checkpoint inhibition: Using a Targeted Cancer Vaccine (Galinpepimut-S) with Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov) - Nov 18, 2024 P1, N=10, Completed, Active, not recruiting --> Completed | N=90 --> 26 Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Nov 2024 | Trial primary completion date: Jul 2025 --> Nov 2024
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Azedra (iobenguane I 131) / Lantheus, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial primary completion date: MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov) - Nov 18, 2024 P1, N=45, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Nov 2024 | Trial primary completion date: Jul 2025 --> Nov 2024 Trial primary completion date: Jun 2023 --> Feb 2024
- |||||||||| Leukine (sargramostim) / Partner Therap
Biomarker, Trial completion: Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease (clinicaltrials.gov) - Nov 6, 2024 P1, N=11, Completed, Long-term repeated inhalation of sargramostim led to iBALT formation in the lower respiratory tract, even at the clinical dose of 5 Active, not recruiting --> Completed
- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment open, Combination therapy: NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (clinicaltrials.gov) - Nov 6, 2024 P2, N=62, Recruiting, Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||||| Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date, 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) - Oct 22, 2024 P2, N=41, Active, not recruiting, N=24 --> 0 | Trial completion date: Jul 2025 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2025 --> Oct 2024 Trial completion date: Sep 2024 --> Sep 2025
- |||||||||| Leukine (sargramostim) / Partner Therap, Molgradex (molgramostim) / Savara, Nobelpharma
Pulmonary Alveolar Proteinosis; Treatment Update by Clinical Trials (CRYSTAL 2; 3F) - Oct 21, 2024 - Abstract #KATRDIC2024KATRDIC_73; One Japanese study has shown that GM-CSF (sargramostim) inhalation can improve significantly compared with placebo inhalation (Tazawa, et al...The other global clinical trial of GM-CSF (molgramostim) inhalation could not show the significant effects (Trapnell, et al...This year is epoch making for APAP patients. I would like to show you the history of GM-CSF inhalation therapy during the past 20 years.
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial primary completion date, Post-transplantation: GM-CSF With Post-Transplant Cyclophosphamide (clinicaltrials.gov) - Oct 17, 2024 P2, N=38, Recruiting, Trial completion date: Sep 2024 --> Sep 2025 Trial primary completion date: Sep 2024 --> Sep 2025
- |||||||||| Leukine (sargramostim) / Partner Therap
Trial completion date, Trial primary completion date: SESAD: Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (clinicaltrials.gov) - Oct 1, 2024 P2, N=42, Recruiting, Given the high risk of further relapse, patient/caregivers often requested extended treatment, which was feasible without evidence of unanticipated or cumulative toxicity. Trial completion date: Jul 2025 --> Oct 2026 | Trial primary completion date: Jul 2025 --> Apr 2026
- |||||||||| AST-302 / Aston Sci., EpiThany
Trial completion, Enrollment change, Metastases: WOKVAC: Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission (clinicaltrials.gov) - Sep 19, 2024 P1, N=32, Completed, Unknown status --> Completed | Phase classification: PN/A --> P1/2 Active, not recruiting --> Completed | N=24 --> 32
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Azedra (iobenguane I 131) / Lantheus, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date: MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov) - Sep 4, 2024 P1, N=45, Active, not recruiting, Active, not recruiting --> Completed | N=24 --> 32 Trial completion date: Jun 2024 --> Jun 2025
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap, Yervoy (ipilimumab) / BMS
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Metastatic Solid Cancer Clinical Trial (clinicaltrials.gov) - Jul 23, 2024 P2, N=32, Active, not recruiting, These findings suggest that the exponential increase in neurodegeneration with age, accelerated by neuroinflammation, may underlie the contribution of aging to cognitive decline and AD and can be halted by GM-CSF/sargramostim treatment. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| AST-301 / University of Washington, Aston Sci., EpiThany
Trial primary completion date: Conerstone3: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (clinicaltrials.gov) - Jul 9, 2024 P2, N=24, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Trial primary completion date: Oct 2023 --> Oct 2025
- |||||||||| Leukine (sargramostim) / Partner Therap, Danyelza (naxitamab) - Y / mAbs Therap
Phase classification, Trial completion date, Trial primary completion date: Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov) - Jul 3, 2024 P1, N=48, Active, not recruiting, Trial completion date: Nov 2024 --> Dec 2027 Phase classification: P2 --> P1 | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
- |||||||||| Leukine (sargramostim) / Partner Therap
Biomarker, Trial completion date: Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease (clinicaltrials.gov) - Jun 17, 2024 P1, N=11, Active, not recruiting, These findings suggest that age-associated exponential increases in neurodegeneration may underlie the contribution of aging to cognitive decline, including in AD, and that GM-CSF/sargramostim treatment may halt these effects. Trial completion date: May 2024 --> Dec 2024
- |||||||||| AST-301 / University of Washington, Aston Sci., EpiThany
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Cornerstone001: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer (clinicaltrials.gov) - Jun 16, 2024 P2, N=10, Terminated, Trial completion date: May 2024 --> Dec 2024 N=146 --> 10 | Trial completion date: Dec 2025 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> May 2024; Difficulty in recruiting patients
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap, Yervoy (ipilimumab) / BMS
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: ABSCOPAL 5001: A Phase 2 Trial for Patients With Metastatic Solid Cancer (clinicaltrials.gov) - May 9, 2024 P2, N=32, Active, not recruiting, WLL plus inhaled sargramostim may be useful as combined therapy for aPAP.1Eur Respir J. 2024; 63(1):2301233. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date: Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov) - Apr 25, 2024 P3, N=1449, Active, not recruiting,
- |||||||||| Leukine (sargramostim) / Partner Therap, Zelboraf (vemurafenib) / Roche
Cutaneous melanoma during pregnancy: Management and real-world outcomes. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4976; Melanoma diagnosed during pregnancy can be safely and effectively staged with sentinel lymph node surgery, MRI imaging (PET-MRI vs standard), and CT imaging with shielding without a need for early induction of labor nor a delay in cancer care. Furthermore, we report a patient with stage IV disease treated with vemurafenib during and immunotherapy after pregnancy, indicating that treating stage IV PAM with systemic therapy is a consideration.
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