Malignant Pleural MesotheliomaPhase 2NCT01265433
Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
A Phase 2 study testing Galinpepimut-S + Montanide + GM-CSF and Montanide + GM-CSF in people with Malignant Pleural Mesothelioma, run by Sellas Life Sciences Group at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- Galinpepimut-S + Montanide + GM-CSF and Montanide + GM-CSF
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2010to 25 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution.
- Positive immunohistochemical staining for WT-1 (greater than 10% of cells).
- Completion of multimodality therapy. This must include surgical resection by either pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible. Patients should have also received treatment with chemotherapy and/or radiation. Patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy.
- 4-12 weeks since completion of combined modality therapy.
- Age > or = to 18 years
- Karnofsky performance status > or = to 70%
- Hematologic parameters: Absolute neutrophil count > or = to 1000/mcL, Platelets > or = to 50K/mcL.
- Biochemical parameters: Total bilirubin < or = to 2.0 mg/dl, AST and ALT < or = to 2.5 x upper limits of normal, Creatinine < or = to 2.0 mg/dl.
Who cannot join
- Pregnant or lactating women.
- Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments.
- Patients with a serious unstable medical illness or another active cancer.
- Patients taking systemic corticosteroids.
- Patients with an immunodeficiency syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Randomized Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients With Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy
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.
Read the detailed description
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.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- Galinpepimut-S + Montanide + GM-CSF, Montanide + GM-CSF
- Keywords
- GM-CSF, MONTANIDE ISA 51, WT1 PEPTIDE SPECIFIC T CELLS, Vaccine, 10-134, Galinpepimut-S
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galinpepimut-S + Montanide + GM-CSFBiological
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.
Montanide + GM-CSFBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Galinpepimut-S + Montanide + GM-CSF | Experimental | Galinpepimut-S emulsified with Montanide adjuvant (1:1 ratio) 1 mL and GM-CSF 70 mcg Receives: Biological: Galinpepimut-S + Montanide + GM-CSF |
| Montanide + GM-CSF | Placebo comparator | Montanide adjuvant 1 mL and GM-CSF 70 mcg Receives: Biological: Montanide + GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years and 11 months
Secondary outcomes (2)
Overall Survival
Median overall survival (OS) is estimated from time of randomization to all cause mortality
Measured: Uo to 5 years and 11 months
Immune Response
Immunogenicity of galinpepimut-S and control from a subset of participants
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study start21 Dec 2010
- Primary completion30 Nov 2016
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sellas Life Sciences Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Marjorie Zauderer, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265433
- Sponsor's protocol ID
- 10-134
- Status last verified
- Oct 2024
- First submitted
- 21 Dec 2010
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zauderer MG, Tsao AS, Dao T, Panageas K, Lai WV, Rimner A, Rusch VW, Adusumilli PS, Ginsberg MS, Gomez D, Rice D, Mehran R, Scheinberg DA, Krug LM. A Randomized Phase II Trial of Adjuvant Galinpepimut-S, WT-1 Analogue Peptide Vaccine, After Multimodality Therapy for Patients with Malignant Pleural Mesothelioma. Clin Cancer Res. 2017 Dec 15;23(24):7483-7489. doi: 10.1158/1078-0432.CCR-17-2169. Epub 2017 Sep 28.
PubMed 28972039
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients With Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy
- ClinicalTrials.gov ID
- NCT01265433
- Acronym / sponsor ID
- 10-134
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- GM-CSF, MONTANIDE ISA 51, WT1 PEPTIDE SPECIFIC T CELLS, Vaccine, 10-134, Galinpepimut-S
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sellas Life Sciences GroupIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 21 Dec 2010 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galinpepimut-S + Montanide + GM-CSF | Experimental | Biological: Galinpepimut-S + Montanide + GM-CSFGalinpepimut-S emulsified with Montanide adjuvant (1:1 ratio) 1 mL and GM-CSF 70 mcg |
| Montanide + GM-CSF | Placebo comparator | Biological: Montanide + GM-CSFMontanide adjuvant 1 mL and GM-CSF 70 mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution.
- Positive immunohistochemical staining for WT-1 (greater than 10% of cells).
- Completion of multimodality therapy. This must include surgical resection by either pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible. Patients should have also received treatment with chemotherapy and/or radiation. Patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy.
- 4-12 weeks since completion of combined modality therapy.
- Age > or = to 18 years
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments.
- Patients with a serious unstable medical illness or another active cancer.
- Patients taking systemic corticosteroids.
- Patients with an immunodeficiency syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galinpepimut-S + Montanide + GM-CSFPatients 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. | Biological | Galinpepimut-S + Montanide + GM-CSF |
| Montanide + GM-CSFPatients 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. | Biological | Montanide + GM-CSF |
Primary outcome
1-year Progression-free Survival
Time frame: 1 year
Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
Progression-free Survival
Time frame: Up to 5 years and 11 months
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.
2 secondary outcomes
Overall Survival
Time frame: Uo to 5 years and 11 months
Immune Response
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28972039Zauderer MG, Tsao AS, Dao T, Panageas K, Lai WV, Rimner A, Rusch VW, Adusumilli PS, Ginsberg MS, Gomez D, Rice D, Mehran R, Scheinberg DA, Krug LM. A Randomized Phase II Trial of Adjuvant Galinpepimut-S, WT-1 Analogue Peptide Vaccine, After Multimodality Therapy for Patients with Malignant Pleural Mesothelioma. Clin Cancer Res. 2017 Dec 15;23(24):7483-7489. doi: 10.1158/1078-0432.CCR-17-2169. Epub 2017 Sep 28.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Malignant Pleural Mesothelioma
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
Active, not recruitingPhase 1
Safety and Preliminary Antitumor Activity of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjorie Zauderer, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Galinpepimut-S + Montanide + GM-CSF and Montanide + GM-CSF in people with Malignant Pleural Mesothelioma, run by Sellas Life Sciences Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Progression-free Survival (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.