A Phase 2 interventional study of Galinpepimut-S + Montanide + GM-CSF and Montanide + GM-CSF in Malignant Pleural Mesothelioma, sponsored by Sellas Life Sciences Group. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Sellas Life Sciences Group · Phase 2, Interventional, and Treatment
Study of galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth.
The doctors are testing galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth. Mesothelioma tumors generally have high levels of WT1.This study was originally designed to have two treatment groups. One group received non-specific immunotherapy with medications called Montanide and Sargramostim (Granulocyte Macrophage Colony Stimulating Factor, GM-CSF). Enrollment to this group has stopped The other group, which continues receives more specific immunotherapy with galinpepimut-S plus Montanide and GM-CSF. Both Montanide and GM-CSF are commonly given along with vaccines because they have a general effect in boosting the immune response. Some researchers believe that this general increase in the immune system may have some effect in treating cancer. Some studies using GM-CSF with melanoma vaccines have suggested that it could lessen the effects of the vaccine. The addition of the WT1 proteins makes this therapy more directed to mesothelioma. The combination of galinpepimut-S with Montanide and GM-CSF has been tested in a prior trial including 9 patients with advanced mesothelioma. In that trial, the vaccine was safe and caused an immune response.
339 studies on the registry are indexed under Mesothelioma, Malignant; 64 are open to participants now.
This study's enrollment of 41 is close to the median of 39 across 271 interventional studies indexed under Mesothelioma, Malignant.
Browse Mesothelioma, Malignant studies →Sellas Life Sciences Group is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Galinpepimut-S emulsified with Montanide adjuvant (1:1 ratio) 1 mL and GM-CSF 70 mcg
Biological: Galinpepimut-S + Montanide + GM-CSF
Montanide adjuvant 1 mL and GM-CSF 70 mcg
Biological: Montanide + GM-CSF
Drug pages: Galinpepimut-s · Monatide (IMS 3015) · Granulocyte-Macrophage Colony-Stimulating Factor
Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self administered) subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.
Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self-administered)subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.
1-year Progression-free Survival
Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
Time frame: 1 year
Progression-free Survival
Median progression free survival (PFS) is where PFS are assessed from the time of randomization to first evidence of disease recurrence or death of any cause.
Time frame: Up to 5 years and 11 months
Overall Survival
Median overall survival (OS) is estimated from time of randomization to all cause mortality
Time frame: Uo to 5 years and 11 months
Immune Response
Immunogenicity of galinpepimut-S and control from a subset of participants
Time frame: 12 weeks
| Milestone | Galinpepimut-S + Montanide + GM-CSF | Montanide + GM-CSF |
|---|---|---|
| Started | 20 | 21 |
| Completed | 20 | 21 |
| Not completed | 0 | 0 |
Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
| percentage of participants | Galinpepimut-S | Control |
|---|---|---|
| 1-year Progression-free Survival | 44 | 33 |
Median progression free survival (PFS) is where PFS are assessed from the time of randomization to first evidence of disease recurrence or death of any cause.
| months | Galinpepimut-S | Control |
|---|---|---|
| Progression-free Survival | 10.1 (5.5 to 20.8) | 7.4 (2.8 to 14.6) |
Median overall survival (OS) is estimated from time of randomization to all cause mortality
| months | Galinpepimut-S | Control |
|---|---|---|
| Overall Survival | 22.8 (9.1 to 37.6) | 18.3 (10.2 to 28) |
Immunogenicity of galinpepimut-S and control from a subset of participants
| Participants | Galinpepimut-S | Control |
|---|---|---|
| CD4 Elispot — Positive | 4 | 1 |
| CD4 Elispot — Negative | 4 | 8 |
| CD4 Elispot — Not tested | 2 | 3 |
| CD8 Elispot — Positive | 1 | 1 |
| CD8 Elispot — Negative | 1 | 3 |
| CD8 Elispot — Not tested | 8 | 8 |
| Tetramer assay positive — Positive | 1 | 2 |
| Tetramer assay positive — Negative | 0 | 3 |
| Tetramer assay positive — Not tested | 9 | 7 |
Collected over Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Galinpepimut-S | 16/20 (80%) | 1/20 (5%) | 17/20 (85%) |
| Control | 20/21 (95.2%) | 1/21 (4.8%) | 10/21 (47.6%) |
| Event | Galinpepimut-S | Control |
|---|---|---|
| LymphopeniaBlood and lymphatic system disorders | 1/20 | 1/21 |
| Event | Galinpepimut-S | Control |
|---|---|---|
| Injection site reactionSurgical and medical procedures | 17/20 | 9/21 |
| FatigueGeneral disorders | 10/20 | 10/21 |
| FeverImmune system disorders | 0/20 | 4/21 |
| NauseaGeneral disorders | 2/20 | 0/21 |
| ArthralgiasMusculoskeletal and connective tissue disorders | 0/20 | 2/21 |
| Rash, maculopapularSkin and subcutaneous tissue disorders | 1/20 | 1/21 |
| LymphopeniaBlood and lymphatic system disorders | 1/20 | 1/21 |
| Age, Continuous(years) | Galinpepimut-S | Control | Total |
|---|---|---|---|
| Median | 70 (34 to 84) | 67 (48 to 79) | 68 (34 to 84) |
| Sex: Female, Male(Participants) | Galinpepimut-S | Control | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 17 | 18 | 35 |
| Race and Ethnicity Not Collected(Participants) | Galinpepimut-S | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Karnofsky performance status at enrollment(Participants) | Galinpepimut-S | Control | Total |
|---|---|---|---|
| 70% | 1 | 3 | 4 |
| 80% | 7 | 12 | 19 |
| 90% | 11 | 6 | 17 |
| 100% | 1 | 0 | 1 |
| Smoking status(Participants) | Galinpepimut-S | Control | Total |
|---|---|---|---|
| Former | 12 | 13 | 25 |
| Current | 0 | 0 | 0 |
| Never | 8 | 8 | 16 |
| Histology(Participants) | Galinpepimut-S | Control | Total |
|---|---|---|---|
| Epithelioid | 18 | 21 | 39 |
| Mixed | 2 | 0 | 2 |
| Sarcomatoid | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2010 to primary completion in Nov 2016, 71 months.
Results were first posted in Oct 2024, 7 years 10 months after primary completion.
Of 48 phase 2 interventional studies under Mesothelioma, Malignant, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 87. This study's 71 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Galinpepimut-s · Monatide (IMS 3015) · Granulocyte-Macrophage Colony-Stimulating Factor
Sellas Life Sciences Group