Clinical trials: sargramostim, completed
Prostate Cancer Metastatic
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
- Trial name
- Prospect (NCT01322490)
- Testing
- PROSTVAC-V, PROSTVAC-F, GM-CSF
- Where
- 220 sites in United States, Australia and 14 more
- Volunteers
- 1,297 people
- Sponsor
- Bavarian Nordic
Non-small Cell Lung Cancer
A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer.
In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed.
- Trial name
- UV1-hTERT2012L (NCT01789099)
- Testing
- UV1 synthetic peptide vaccine and GM-CSF
- Where
- Norway
- Volunteers
- 18 people
- Sponsor
- Ultimovacs ASA
Malignant Glioma
Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy).
- Trial name
- ACT III (NCT00458601)
- Testing
- CDX-110 with GM-CSF, Temozolomide
- Where
- 34 sites in United States
- Volunteers
- 82 people
- Sponsor
- Celldex Therapeutics
Colorectal Cancer
Safety and Immune Response to FMPV-1
This is a single centre, open-label, non-randomized, Phase I study assessing safety and immune response of FMPV-1 in healthy male subjects.
- Trial name
- NCT05238558
- Testing
- FMPV-1, GM-CSF (as adjuvant)
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hubro Therapeutics AS
Adult Brain Glioblastoma, Glioblastoma Multiforme
Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme
The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment for recurrent glioblastoma multiform (GBM).
- Trial name
- NCT02078648
- Testing
- SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose), Bevacizumab, SL-701 + GM-CSF
- Where
- 16 sites in United States
- Volunteers
- 74 people
- Sponsor
- Stemline Therapeutics, Inc.
Colorectal Carcinoma, CRC
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to…
- Trial name
- NCT01394939
- Testing
- JX-594, Irinotecan
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 52 people
- Sponsor
- Jennerex Biotherapeutics
Breast Cancer With Low to Intermediate HER2 Expression
Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence
Purpose of this trial: 1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF). 2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.
- Trial name
- PRESENT (NCT01479244)
- Testing
- NeuVax™ vaccine, Leukine® (sargramostim, GM-CSF) and water for injection
- Where
- 197 sites in United States, Bulgaria and 11 more
- Volunteers
- 758 people
- Sponsor
- Galena Biopharma, Inc.
HIV I Infection
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal…
- Trial name
- NCT00659789
- Testing
- Vacc-4x, Sterile water
- Where
- 18 sites in United States, Germany and 3 more
- Volunteers
- 137 people
- Sponsor
- Bionor Immuno AS
Multiple Myeloma
WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation
The purpose of this trial is to assess the immune response after vaccination with a peptide vaccine called galinpepimut-S (or GPS) in a type of blood cancer called multiple myeloma.
- Trial name
- NCT01827137
- Testing
- Galinpepimut-S, GM-CSF, Montanide
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sellas Life Sciences Group
Breast Cancer
Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients
This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone.
- Trial name
- HER3+ (NCT02297698)
- Testing
- NeuVax vaccine, Trastuzumab, GM-CSF
- Where
- 24 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cancer Insight, LLC
Infertility
Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium will increase the chance of a pregnancy after in vitro fertilisation.
- Trial name
- GM-CSF (NCT00565747)
- Testing
- Test culture, Control culture
- Where
- 14 sites in Denmark, Sweden
- Volunteers
- 1,332 people
- Sponsor
- Origio A/S
Metastatic Prostate Cancer
A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.
- Trial name
- NCT01981122
- Testing
- sipuleucel-T, enzalutamide
- Where
- 19 sites in United States
- Volunteers
- 52 people
- Sponsor
- Dendreon
Carcinoma, Hepatocellular
A Study of Recombinant Vaccinia Virus to Treat Unresectable Primary Hepatocellular Carcinoma
The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine the dose to be used in further testing.
- Trial name
- NCT00554372
- Testing
- JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- Jennerex Biotherapeutics
Metastatic Renal Cell Carcinoma
IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy…
- Trial name
- NCT01265901
- Testing
- Sunitinib, GM-CSF, Cyclophosphamide
- Where
- 105 sites in United States, France and 9 more
- Volunteers
- 339 people
- Sponsor
- Immatics Biotechnologies GmbH
Drug Kinetics, Drug Effects on Physiology
Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Sargramostim Administered Subcutaneously, Intravenously, or by Inhalation
This single center, single ascending dose (SAD) and repeat dose study in healthy adults comprises 2 parts. Part 1 will consist of 6 SAD cohorts, in which different dose levels of sargramostim will be given by intravenous (IV)…
- Trial name
- NCT05366283
- Testing
- sargramostim
- Where
- Canada
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Partner Therapeutics, Inc.
Prostatic Neoplasm, Prostate Cancer
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response.
- Conditions
- Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma
- Trial name
- NCT01431391
- Testing
- sipuleucel-T, leuprolide acetate
- Where
- 14 sites in United States
- Volunteers
- 68 people
- Sponsor
- Dendreon
Prostate Cancer
Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
- Trial name
- NCT00901342
- Testing
- sipuleucel-T
- Where
- 18 sites in United States
- Volunteers
- 104 people
- Sponsor
- Dendreon
Arthritis, Rheumatoid
Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis
This study is designed to explore the activity of granulocyte-macrophage colony stimulating factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential impact of inhibition of this axis by…
- Trial name
- NCT02799472
- Testing
- GSK3196165, MTX, Folic (or folinic) acid
- Where
- 16 sites in United States, Germany and 1 more
- Volunteers
- 39 people
- Sponsor
- GlaxoSmithKline
COVID-19, SARS-CoV-2
Study of Sargramostim in Patients With COVID-19
The purpose of this research is to find out if a drug (sargramostim) also known as Leukine® could help patient recover faster from COVID-19.
- Trial name
- iLeukPulm (NCT04411680)
- Testing
- Sargramostim, Standard of care
- Where
- 11 sites in United States
- Volunteers
- 123 people
- Sponsor
- Partner Therapeutics, Inc.
Glioblastoma
GAPVAC Phase I Trial in Newly Diagnosed Glioblastoma Patients
The primary objective of this study is to assess the safety and tolerability, feasibility and biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept in newly diagnosed glioblastoma (GB)…
- Trial name
- NCT02149225
- Testing
- APVAC1 vaccine plus Poly-ICLC and GM-CSF, APVAC2 vaccine plus Poly-ICLC and GM-CSF
- Where
- 6 sites in Denmark, Germany and 3 more
- Volunteers
- 16 people
- Sponsor
- Immatics Biotechnologies GmbH