Malignant Pleural Mesothelioma (MPM)Phase 1NCT02661659
A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
A Phase 1 study testing Multipeptide vaccine S-588210 in people with Malignant Pleural Mesothelioma (MPM), run by University of Chicago at 1 site in United States.
Trial summary
A phase Ib study investigating the safety, the immunogenicity and the optimal administration frequency of the S-588210 5-peptide vaccine in MPM patients without progression after pemetrexed-based chemotherapy will be conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma (MPM)
- What is being tested?
- Multipeptide vaccine S-588210
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2016to 3 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients with unresectable MPM that have completed 4-6 cycles of standard first-line pemetrexed-based chemotherapy for at least 1 month and have not progressed
- Age>18
- Able to provide informed consent for the study
- HLA-A*02:01 positive
- ECOG PS=0-1 at enrollment
- Measurable indicator lesion by modified RECIST criteria
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- Adequate bone marrow (ANC > 1000cells/ml, PLT > 50,000/ml, Hg > 8gr/dL), renal (Cr > 2.5xUNL) and liver function (AST, ALT< 3x UNL, total bilirubin < 2x UNL, ALP < 3x UNL)
- Archival tumor tissue available for IHC (1 paraffin-embedded block)
- Epithelioid or biphasic histology
Who cannot join
- Chemotherapy or investigational antineoplastic drug within 1 month of planned initiation of vaccine therapy
- Patients who received DEPDC1, MPHOSPH1, URLC10, CDCA1, or KOC1 peptide vaccines before
- Active treatment with corticosteroids or other immunosuppressive agents
- Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment:
- immunosuppressive drugs, including corticosteroids, methotrexate, mercaptopurine, azathioprine, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, ATG (anti-thymoglobulin), IL2-receptor antibodies (basiliximab, daclizumab), TNF-a antibodies (infliximab, etanercept, adalimumab)
- radiotherapy for the target disease
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- surgical therapy for the target disease
- History of bone marrow transplantation
- Active infection
- Human immunodeficiency virus infection
- History of or active systemic autoimmune disorder or immunodeficiency syndromes
- History of severe (CTCAE v.4.03 grade 3 or higher) allergic reaction to a drug, vaccination, or biological preparation.
- Pregnancy
- Patients who cannot or do not intend to practice effective contraception
- Severe illness requiring hospitalization
- Lymphocytes <15% of total WBCs at baseline
- Sarcomatoid histology
- Severe (CTCAE v.4.03 grade 3 or higher) concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
A phase Ib study investigating the safety, the immunogenicity and the optimal administration frequency of the S-588210 5-peptide vaccine in MPM patients without progression after pemetrexed-based chemotherapy will be conducted. Additionally, to identify more accurate predictive biomarkers of response to S-588210, T-cell-receptor-sequencing (TCR) pre- and post-vaccination will be performed in blood samples of patients treated with the vaccine. Immunohistochemical analysis of the vaccine oncoantigens will also be correlated with induction of antigen-specific T-cell responses. Finally, to explore the infiltration of tumors with T-cells and the potential presence of an immunosuppressive tumor microenvironment, immunohistochemistry for immune checkpoints (including PDL1/PD1, CTLA4) and immune suppressive cell subsets (T-regs, macrophages) will be performed.
Read the detailed description
Primary Objective:
To evaluate the rate of peptide-specific CTL induction to S-588210 within the first 8 months in HLA-A*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy treated on a weekly or every other week vaccination schedule.
Secondary Objectives:
- To evaluate the safety of S-588210 in HLA-A*02:01-positive patients with MPM treated with S-588210
- To determine the disease control rate (DCR) in HLA-A*02:01-positive patients with MPM treated with S-588210
- To determine the progression-free-survival (PFS) in HLA-A*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy and who are treated with S-588210
- To evaluate the peptide-specific CTL response to S-588210 over time up to 8 months in HLA-A*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy
- Conditions
- Malignant Pleural Mesothelioma (MPM)
- Being tested
- Multipeptide vaccine S-588210
- Keywords
- mesothelioma, multipeptide vaccine, S-588210
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multipeptide vaccine S-588210Biological
| Study group | Role | What they receive |
|---|---|---|
| Weekly Vaccination | Other | Maintenance multipeptide vaccine (S-588210) administered every week Receives: Biological: Multipeptide vaccine S-588210 |
| Every other Week Vaccination | Other | Maintenance multipeptide vaccine (S-588210) administered every other week Receives: Biological: Multipeptide vaccine S-588210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who show in vitro cytotoxic T lymphocyte induction to at least 2 of the 5 antigens determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay
Measured: Within 8 months from initiation of vaccination
Secondary outcomes (4)
Toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: Up to 4 weeks
Disease control rate defined as the proportion of patients who are assessed as having complete response (CR), partial response (PR), or stable disease (SD) (>3 months)
Measured: 6 months
6-month progression-free survival (PFS) rate
Measured: 6 months
Peptide-specific cytotoxic T lymphocyte response determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay
Measured: At 2, 3, 4, 6 and 8 months of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study start12 Jun 2016
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Why it stopped: PI stopped study due to inability to accrue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural Mesothelioma (MPM)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661659
- Sponsor's protocol ID
- IRB14-1519
- Status last verified
- May 2018
- First submitted
- 20 Jan 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT02661659
- Acronym / sponsor ID
- IRB14-1519
- Conditions
- Malignant Pleural Mesothelioma (MPM)
- Keywords
- mesothelioma, multipeptide vaccine, S-588210
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI stopped study due to inability to accrue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 12 Jun 2016 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase Ib study investigating the safety, the immunogenicity and the optimal administration frequency of the S-588210 5-peptide vaccine in MPM patients without progression after pemetrexed-based chemotherapy will be conducted. Additionally, to identify more accurate predictive biomarkers of response to S-588210, T-cell-receptor-sequencing (TCR) pre- and post-vaccination will be performed in blood samples of patients treated with the vaccine. Immunohistochemical analysis of the vaccine oncoantigens will also be correlated with induction of antigen-specific T-cell responses. Finally, to explore the infiltration of tumors with T-cells and the potential presence of an immunosuppressive tumor microenvironment, immunohistochemistry for immune checkpoints (including PDL1/PD1, CTLA4) and immune suppressive cell subsets (T-regs, macrophages) will be performed.
Detailed description
Primary Objective:
To evaluate the rate of peptide-specific CTL induction to S-588210 within the first 8 months in HLA-A*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy treated on a weekly or every other week vaccination schedule.
Secondary Objectives:
- To evaluate the safety of S-588210 in HLA-A*02:01-positive patients with MPM treated with S-588210
- To determine the disease control rate (DCR) in HLA-A*02:01-positive patients with MPM treated with S-588210
- To determine the progression-free-survival (PFS) in HLA-A*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy and who are treated with S-588210
- To evaluate the peptide-specific CTL response to S-588210 over time up to 8 months in HLA-A*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Vaccination | Other | Biological: Multipeptide vaccine S-588210Maintenance multipeptide vaccine (S-588210) administered every week |
| Every other Week Vaccination | Other | Biological: Multipeptide vaccine S-588210Maintenance multipeptide vaccine (S-588210) administered every other week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with unresectable MPM that have completed 4-6 cycles of standard first-line pemetrexed-based chemotherapy for at least 1 month and have not progressed
- Age>18
- Able to provide informed consent for the study
- HLA-A*02:01 positive
- ECOG PS=0-1 at enrollment
Key exclusion criteria (18 listed)
- Chemotherapy or investigational antineoplastic drug within 1 month of planned initiation of vaccine therapy
- Patients who received DEPDC1, MPHOSPH1, URLC10, CDCA1, or KOC1 peptide vaccines before
- Active treatment with corticosteroids or other immunosuppressive agents
- Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment:
- History of bone marrow transplantation
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 |
|---|---|---|
| Multipeptide vaccine S-588210 | Biological | Every other Week Vaccination, Weekly Vaccination |
Primary outcome
Proportion of patients who show in vitro cytotoxic T lymphocyte induction to at least 2 of the 5 antigens determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay
Time frame: Within 8 months from initiation of vaccination
4 secondary outcomes
Toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Time frame: Up to 4 weeks
Disease control rate defined as the proportion of patients who are assessed as having complete response (CR), partial response (PR), or stable disease (SD) (>3 months)
Time frame: 6 months
6-month progression-free survival (PFS) rate
Time frame: 6 months
Peptide-specific cytotoxic T lymphocyte response determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay
Time frame: At 2, 3, 4, 6 and 8 months of vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multipeptide vaccine S-588210 in people with Malignant Pleural Mesothelioma (MPM), run by University of Chicago 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 9 inclusion and 18 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: withdrawn, as of the sponsor's last update on 14 May 2018. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients who show in vitro cytotoxic T lymphocyte induction to at least 2 of the 5 antigens determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay (time frame: Within 8 months from initiation of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2018.