Table of contents
- Overview of Sargramostim trials
- Conditions being studied
- Trial phases and what they mean
- Main outcomes measured
- Who is being studied
- Key trial examples
- What these studies may add
Overview of Sargramostim trials
The trial data show Sargramostim being used in cancer research across several different studies.[1] It is usually tested as part of a combination approach, together with vaccines, immunotherapy, or other cancer treatments.[1][2]
These studies are interventional trials, which means the research team gives a study treatment and then measures the results.[1] The trials are designed to learn about safety, effectiveness, and immune response in people with specific cancers.[1][2]
Conditions being studied
Sargramostim appears in trials for a wide range of cancers and cancer-related conditions.[1] These include unresectable locally advanced or metastatic colorectal cancer, advanced or metastatic non-small cell lung cancer, breast cancer, ovarian cancer, malignant pleural mesothelioma, acute myeloid leukemia, high-risk neuroblastoma, and pseudomyxoma peritonei.[1][2]
Some studies focus on people whose disease has returned, has not responded fully, or is at high risk of coming back.[1][2] For example, one breast cancer study includes people with residual disease or high risk of recurrence after standard treatment.[3]
Trial phases and what they mean
The listed studies include Phase 1, Phase 1/2, Phase 2, Phase 3, and Phase 4 trials.[1] Early-phase studies mainly look at safety and the best treatment plan, while later-phase studies focus more on whether the treatment helps patients.[1][2]
For example, the colorectal cancer study is Phase 1/2 and aims to define the recommended Phase 2 dose and the maximum tolerated dose, then test early efficacy.[1] The breast cancer study is Phase 3 and compares outcomes in a larger group of patients at high risk of recurrence.[3]
Main outcomes measured
The trials measure several important outcomes, depending on the cancer and phase.[1][2] Common outcomes include progression-free survival, overall survival, objective response rate, safety, and immune response.[1][2]
Safety outcomes include treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, and treatment stops caused by side effects.[1] Some studies also use imaging or standard response rules such as RECIST or modified RECIST to see whether the cancer is shrinking, stable, or growing.[1][2]
In the pseudomyxoma peritonei study, researchers also measure T cell responses in blood and skin, which is a way to see how the immune system reacts to the treatment.[8]
Who is being studied
The trials include adults with specific cancer types and, in some studies, very specific disease settings.[1][2] Some participants have metastatic disease, meaning the cancer has spread, while others have disease that is unresectable, meaning it cannot be fully removed with surgery.[1]
Several studies focus on people after first-line treatment or after standard therapy has already been given.[2][3] One mesothelioma study looks at patients whose disease progressed after first-line platinum-based chemotherapy.[5]
Key trial examples
In the colorectal cancer study, Sargramostim is part of the STC-1010 plus immunotherapy strategy with standard chemotherapy, and the main goals are safety in Phase 1 and 12-month progression-free survival in Phase IIa.[1] This trial is authorised and plans to enroll 100 participants.[1]
In the non-small cell lung cancer study, Sargramostim is given with UV1 vaccination, and the trial compares progression-free survival in patients with stage IIIB/IIIC or stage IV disease.[2] This Phase 2 study is completed and enrolled 141 participants.[2]
In the breast cancer study, Sargramostim appears in a Phase 3 trial of GLSI-100 for HER2/neu positive patients with residual disease or high risk of recurrence after trastuzumab-based therapy.[3] The main outcome is invasive breast cancer-free survival, which tracks time until breast cancer comes back, spreads, or causes death.[3]
In the ovarian cancer study, Sargramostim is part of a maintenance treatment comparison that looks at progression-free survival between treatment arms.[4] This Phase 2 trial is authorised and plans to enroll 188 participants.[4]
In the mesothelioma study, Sargramostim is used with nivolumab and ipilimumab, with or without UV1 vaccine, to study progression-free survival in inoperable malignant pleural mesothelioma.[5] The study is Phase 4 and includes 118 participants.[5]
In the acute myeloid leukemia trial, Sargramostim is listed among the study drugs in a Phase 3 comparison of Galinpepimut-S versus best available therapy, with median overall survival as the main outcome.[6] The trial includes people in second or later complete remission, or complete remission with incomplete platelet recovery.[6]
In the neuroblastoma study, Sargramostim is given with antibody treatment for high-risk patients with refractory bone or bone marrow disease, and the main outcome is objective response rate.[7] This Phase 2 trial is authorised and plans to enroll 122 participants.[7]
In the pseudomyxoma peritonei study, Sargramostim is part of a Phase 1 vaccine and immunotherapy approach that focuses on safety, tolerability, and immune activation.[8] This is the smallest study listed, with 10 participants planned.[8]
What these studies may add
Together, these trials show that Sargramostim is being explored mainly in cancer combination studies rather than as a single treatment.[1][2] The research aims to learn whether adding Sargramostim can improve cancer control, support immune response, or help maintain remission in different patient groups.[1][8]
The studies also show that patient groups are carefully selected, often by cancer type, stage, prior treatment, or risk of recurrence.[3][5][6] This helps researchers compare results in people with similar medical situations.[1]
