Non Small Cell Lung CancerPhase 1/2TEIPPNCT05898763
TEIPP Immunotherapy in Patients With NSCLC
A Phase 1/2 study testing TEIPP24 (LRPAP7-30V-SLP vaccine in Montanide ISA-51) in people with Non Small Cell Lung Cancer, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial summary
In this multicenter, open label non-randomized phase I/II dose escalation study with extension cohort HLA-A*0201-positive patients with non small cell lung cancer (NSCLC) can be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- TEIPP24 (LRPAP7-30V-SLP vaccine in Montanide ISA-51)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesNetherlands
- Study dates
- 29 Sep 2021to 30 Apr 2024
- Phase
- Phase 1/2
- 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
- Age >18 years
- Pathologically and radiologically confirmed advanced NSCLC.
- Progression after minimally 4 cycles of combination platinum containing chemotherapy and immunotherapy (PD1), or after 4 cycles of platinum containing chemotherapy and immunotherapy (PD-1) followed by maintenance chemo immunotherapy
- HLA-A*0201 positive
- An expected survival of at least 3 months
- WHO/ECOG performance status ≤ 2 (Appendix 3)
Show all 12Show fewer
- Adequate renal function as defined by creatinine clearance > 40 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR)
- Adequate hepatic function as evidenced by
- Serum total bilirubin ≤ 2.5 × upper limit of normal (ULN) unless considered due to hepatic metastases
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to hepatic metastases
- Ability to return to the hospital for adequate follow-up as required by this protocol.
- Written informed consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) .
Who cannot join
- Active infection, including hepatitis B or C or HIV infection that is uncontrolled at inclusion. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed.
- Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 6 weeks interval.
- Concomitant participation in another clinical intervention trial (except participation in a biobank study).
- Pregnant or lactating women.
- Known allergy to any of the ingredients of the vaccine (peptide, Montanide ISA-51, trifluoroacetic acid, acetonitrile, dichloromethane, dimethylsulfoxide).
- Any medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or participate in the study
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Patients with a currently active second malignancy. However, patients with the following history/concurrent conditions are allowed: Basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histologic finding of prostate cancer.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Erasmus Medical Center
Rotterdam, South Holland, 3000 CA
About this study
Official title: T-cell Epitopes Associated With Impaired Peptide Processing (TEIPP)- Targeting Immunotherapy in Patients With Relapsed Advanced Non Small Cell Lung Cancer (NSCLC)
In this multicenter, open label non-randomized phase I/II dose escalation study with extension cohort HLA-A*0201-positive patients with non small cell lung cancer (NSCLC) can be included. The primary aim of this study is determine the safety, tolerability and immune modulating effects of the therapeutic LRPAP1 synthetic long peptide (LRPAP7-30V-SLP) vaccine (TEIPP24) at different doses. Secondary objectives are to assess the specificity and immune modulatory effects of the vaccine, to assess the antigen and immune status of the patients, and to determine progression free survival (PFS), overall survival (OS), and the radiological tumor response up to one year after first vaccination.
Read the detailed description
Immunogenic tumors can be controlled by tumor-reactive Tcells either directly or after checkpoint blockade. In the end, most tumors will develop mechanisms to escape immune control. One of such a mechanism is formed by the functional impairment of the intracellular peptide transporter TAP1/TAP2 by mutation of downregulated expression. As a result the presentation of conventional T-cell epitopes in HLA class I is lost, and hence tumor-reactive CD8+ T-cells fail to recognize and kill tumor cells. This type of immune escape can occur in up to 50% of primary tumors and is increased in the metastatic lesions of such tumors. The presence of these TAP defects correlate with worse clinicopathological parameters and has been associated with loss of durable benefit to checkpoint inhibition. The unmet need, therefore, is the development of a therapy that can reinforce effective tumor-immunity to cancers displaying TAP-defects for which conventional therapeutic cancer vaccines and/or checkpoint blockade do not work. TEIPP therapy may fill this position by reinstalling an effective antitumor response to TAP-defective tumors thereby increasing the overall survival of patients failing first line therapy.
In this prospective, single arm, multicenter, open-label, phase I-II clinical study, HLA-A*0201-positive patients with NSCLC failing first line of treatment will be enrolled in 3 cohorts and one extension cohort of 6 patients (at the highest safe and tolerable dose) combined with a checkpoint inhibitor targeting PD-1/PD-L1 (CPI), to include 24 patients in total. The maximal total treatment duration is 9 weeks. The first 6 patients will be enrolled in cohort 1, the next 6 patients in cohort 2, the next 6 patients in cohort 3. The decision to start enrollment at the next dose level will be made by assessing the safety after 3 out of 6 patients at the previous dose level have completed vaccine therapy.
Patients will receive an off the shelf TEIPP24 vaccine mixed with Montanide ISA-51 adjuvant, which will be administered every three weeks for a period of three rounds of vaccination. Patient cohort 1 will be treated with TEIPP24 at a dose of 20ug of peptide, patients in cohort 2 with TEIPP24 at a dose of 40ug of peptide and patients in cohort 3 with TEIPP24 at a dose of 100ug of peptide. Patients in the extension cohort will receive the highest safest dose in combination with pembrolizumab (a CPI). Patients will receive three rounds of vaccination three weeks apart via one subcutaneous (SC) injection in a limb. The SC route of administration of TEIPP24 vaccine is dictated by the use of Montanide ISA51. Subsequently patients will be followed up to 1 year after the first vaccination.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- TEIPP24 (LRPAP7-30V-SLP vaccine in Montanide ISA-51)
- Keywords
- Immunotherapy, Palliative treatment, Dose-escalation study, Checkpoint inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEIPP24 (LRPAP7-30V-SLP vaccine in Montanide ISA-51)Drug
Also called Pembrolizumab
Patients will receive three rounds of vaccination three weeks apart via one subcutaneous (SC) injection in an alternating limb. Patients in the extension cohort will receive the highest safest dose in combination with pembrolizumab (a CPI).These patients will receive three rounds of combination treatment with TEIPP24 vaccination and pembrolizumab every three weeks. Pembrolizumab will be administered as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients will be vaccinated with the TEIPP24 vaccine in Montanide ISA 51 every three weeks for a total of three rounds of vaccination. The total treatment duration is 9 weeks for each patient. The three dose levels tested are 20, 40 and 100 µg of peptide. Dose 1: 20 µg of peptide in Montanide ISA 51; Dose 2: 40 µg of peptide in Montanide ISA 51; Dose 3: 100 µg of peptide in Montanide ISA 51. Patients in the extension cohort will receive the highest safest dose of peptide in combination with pembrolizumab. Receives: Drug: TEIPP24 (LRPAP7-30V-SLP vaccine in Montanide ISA-51) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment based on the incidence rate of serious adverse drug reactions (ADR) as assessed by NCI-CTCAE version 5.0.
Safety of the therapeutic LRPAP1 synthetic long peptide ( LRPAP7-30V-SLP) vaccine (TEIPP24) determined by the incidence rate at each dose level based on the following safety parameters: adverse drug reactions (ADR) and serious ADRs, changes in haematology and chemistry values, including those associated with hepatic and renal function, and assessment of physical examinations, vital signs and performance status. NCI-CTCAE version 5.0 will be used.
Measured: Week 8 (two weeks after the third TEIPP24 vaccination)
Tolerability assessment based on patients' tolerability of adverse drug reactions (ADR)
Tolerability of the therapeutic LRPAP1 synthetic long peptide ( LRPAP7-30V-SLP) vaccine (TEIPP24) determined by patients' tolerability of ADRs. NCI-CTCAE version 5.0 will be used.
Measured: Week 8 (two weeks after the third TEIPP24 vaccination)
Immunogenicity assessed by HLA-A*0201-restricted LRPAP21-30 -specific CD8+ T-cell reactivity
HLA-A*0201-restricted LRPAP21-30 -specific CD8+ T-cell reactivity will be determined by measuring the magnitude and function of HLA-A*0201-restricted LRPAP21-30 -specific CD8+ Tcells present in the blood and/or tumor samples before and after TEIPP24 vaccination at different dose levels.
Measured: Week 3-6-9 (three weeks after every TEIPP24 vaccination)
Secondary outcomes (5)
The specificity and immune modulatory effect of the vaccine, determined by isolating LRPAP(21-30V)-specific CD8+ T cells
The specificity and immune modulatory effect of the vaccine is determined by isolating LRPAP(21-30V)-specific CD8+ T cells that are cocultured with tumor cells. CD8+ T cells that recognize LRPAP presented on these tumor cells will produce type 1 cytokines which is measured by ELISA.
Measured: Week 3-6-9 (three weeks after every TEIPP24 vaccination)
Immunohistochemical staining of tumor material
The pretreatment (and when available post-vaccination) tumor material will be subjected to immunohistochemical staining for TAP 1, TAP 2, HLA class I and LRPAP.
Measured: Before (week 0) and after treatment (week 9)
Progression free survival (PFS)
Progression free survival (PFS) defined as the time frame between the first vaccination and date of progression
Measured: From week 0 up to week 52
Overall survival (OS)
Overall survival (OS) defined as the time frame between the first vaccination and date of death
Measured: From week 0 up to week 52
Radiological tumor response
To determine the radiological tumor response up to one year after first vaccination according to RECIST v.1.1 criteria.
Measured: From week 0 up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start29 Sep 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- A multicenter, open label non-randomized phase I/II dose escalation study with extension cohort
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Aerts, MD PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898763
- Sponsor's protocol ID
- NL75654.000.20
- Acronym
- TEIPP
- Status last verified
- Nov 2024
- First submitted
- 24 Apr 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-cell Epitopes Associated With Impaired Peptide Processing (TEIPP)- Targeting Immunotherapy in Patients With Relapsed Advanced Non Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05898763
- Acronym / sponsor ID
- TEIPP / NL75654.000.20
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Immunotherapy, Palliative treatment, Dose-escalation study, Checkpoint inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- 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.
In this multicenter, open label non-randomized phase I/II dose escalation study with extension cohort HLA-A*0201-positive patients with non small cell lung cancer (NSCLC) can be included. The primary aim of this study is determine the safety, tolerability and immune modulating effects of the therapeutic LRPAP1 synthetic long peptide (LRPAP7-30V-SLP) vaccine (TEIPP24) at different doses. Secondary objectives are to assess the specificity and immune modulatory effects of the vaccine, to assess the antigen and immune status of the patients, and to determine progression free survival (PFS), overall survival (OS), and the radiological tumor response up to one year after first vaccination.
Detailed description
Immunogenic tumors can be controlled by tumor-reactive Tcells either directly or after checkpoint blockade. In the end, most tumors will develop mechanisms to escape immune control. One of such a mechanism is formed by the functional impairment of the intracellular peptide transporter TAP1/TAP2 by mutation of downregulated expression. As a result the presentation of conventional T-cell epitopes in HLA class I is lost, and hence tumor-reactive CD8+ T-cells fail to recognize and kill tumor cells. This type of immune escape can occur in up to 50% of primary tumors and is increased in the metastatic lesions of such tumors. The presence of these TAP defects correlate with worse clinicopathological parameters and has been associated with loss of durable benefit to checkpoint inhibition. The unmet need, therefore, is the development of a therapy that can reinforce effective tumor-immunity to cancers displaying TAP-defects for which conventional therapeutic cancer vaccines and/or checkpoint blockade do not work. TEIPP therapy may fill this position by reinstalling an effective antitumor response to TAP-defective tumors thereby increasing the overall survival of patients failing first line therapy.
In this prospective, single arm, multicenter, open-label, phase I-II clinical study, HLA-A*0201-positive patients with NSCLC failing first line of treatment will be enrolled in 3 cohorts and one extension cohort of 6 patients (at the highest safe and tolerable dose) combined with a checkpoint inhibitor targeting PD-1/PD-L1 (CPI), to include 24 patients in total. The maximal total treatment duration is 9 weeks. The first 6 patients will be enrolled in cohort 1, the next 6 patients in cohort 2, the next 6 patients in cohort 3. The decision to start enrollment at the next dose level will be made by assessing the safety after 3 out of 6 patients at the previous dose level have completed vaccine therapy.
Patients will receive an off the shelf TEIPP24 vaccine mixed with Montanide ISA-51 adjuvant, which will be administered every three weeks for a period of three rounds of vaccination. Patient cohort 1 will be treated with TEIPP24 at a dose of 20ug of peptide, patients in cohort 2 with TEIPP24 at a dose of 40ug of peptide and patients in cohort 3 with TEIPP24 at a dose of 100ug of peptide. Patients in the extension cohort will receive the highest safest dose in combination with pembrolizumab (a CPI). Patients will receive three rounds of vaccination three weeks apart via one subcutaneous (SC) injection in a limb. The SC route of administration of TEIPP24 vaccine is dictated by the use of Montanide ISA51. Subsequently patients will be followed up to 1 year after the first vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multicenter, open label non-randomized phase I/II dose escalation study with extension cohort
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: TEIPP24 (LRPAP7-30V-SLP vaccine in Montanide ISA-51)Patients will be vaccinated with the TEIPP24 vaccine in Montanide ISA 51 every three weeks for a total of three rounds of vaccination. The total treatment duration is 9 weeks for each patient. The three dose levels tested are 20, 40 and 100 µg of peptide. Dose 1: 20 µg of peptide in Montanide ISA 51; Dose 2: 40 µg of peptide in Montanide ISA 51; Dose 3: 100 µg of peptide in Montanide ISA 51. Patients in the extension cohort will receive the highest safest dose of peptide in combination with pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >18 years
- Pathologically and radiologically confirmed advanced NSCLC.
- Progression after minimally 4 cycles of combination platinum containing chemotherapy and immunotherapy (PD1), or after 4 cycles of platinum containing chemotherapy and immunotherapy (PD-1) followed by maintenance chemo immunotherapy
- HLA-A*0201 positive
- An expected survival of at least 3 months
Key exclusion criteria (8 listed)
- Active infection, including hepatitis B or C or HIV infection that is uncontrolled at inclusion. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed.
- Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 6 weeks interval.
- Concomitant participation in another clinical intervention trial (except participation in a biobank study).
- Pregnant or lactating women.
- Known allergy to any of the ingredients of the vaccine (peptide, Montanide ISA-51, trifluoroacetic acid, acetonitrile, dichloromethane, dimethylsulfoxide).
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 |
|---|---|---|
| TEIPP24 (LRPAP7-30V-SLP vaccine in Montanide ISA-51)Also: PembrolizumabPatients will receive three rounds of vaccination three weeks apart via one subcutaneous (SC) injection in an alternating limb. Patients in the extension cohort will receive the highest safest dose in combination with pembrolizumab (a CPI).These patients will receive three rounds of combination treatment with TEIPP24 vaccination and pembrolizumab every three weeks. Pembrolizumab will be administered as per standard of care. | Drug | Treatment arm |
Primary outcome
Safety assessment based on the incidence rate of serious adverse drug reactions (ADR) as assessed by NCI-CTCAE version 5.0.
Time frame: Week 8 (two weeks after the third TEIPP24 vaccination)
Safety of the therapeutic LRPAP1 synthetic long peptide ( LRPAP7-30V-SLP) vaccine (TEIPP24) determined by the incidence rate at each dose level based on the following safety parameters: adverse drug reactions (ADR) and serious ADRs, changes in haematology and chemistry values, including those associated with hepatic and renal function, and assessment of physical examinations, vital signs and performance status. NCI-CTCAE version 5.0 will be used.
Tolerability assessment based on patients' tolerability of adverse drug reactions (ADR)
Time frame: Week 8 (two weeks after the third TEIPP24 vaccination)
Tolerability of the therapeutic LRPAP1 synthetic long peptide ( LRPAP7-30V-SLP) vaccine (TEIPP24) determined by patients' tolerability of ADRs. NCI-CTCAE version 5.0 will be used.
Immunogenicity assessed by HLA-A*0201-restricted LRPAP21-30 -specific CD8+ T-cell reactivity
Time frame: Week 3-6-9 (three weeks after every TEIPP24 vaccination)
HLA-A*0201-restricted LRPAP21-30 -specific CD8+ T-cell reactivity will be determined by measuring the magnitude and function of HLA-A*0201-restricted LRPAP21-30 -specific CD8+ Tcells present in the blood and/or tumor samples before and after TEIPP24 vaccination at different dose levels.
5 secondary outcomes
The specificity and immune modulatory effect of the vaccine, determined by isolating LRPAP(21-30V)-specific CD8+ T cells
Time frame: Week 3-6-9 (three weeks after every TEIPP24 vaccination)
Immunohistochemical staining of tumor material
Time frame: Before (week 0) and after treatment (week 9)
Progression free survival (PFS)
Time frame: From week 0 up to week 52
Overall survival (OS)
Time frame: From week 0 up to week 52
Radiological tumor response
Time frame: From week 0 up to week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TEIPP24 (LRPAP7-30V-SLP vaccine in Montanide ISA-51) in people with Non Small Cell Lung Cancer, run by Erasmus Medical Center at 2 sites in Netherlands.
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 12 inclusion and 8 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety assessment based on the incidence rate of serious adverse drug reactions (ADR) as assessed by NCI-CTCAE version 5.0. (time frame: Week 8 (two weeks after the third TEIPP24 vaccination)). The study lists 3 primary outcomes in all. 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 7 Nov 2024; AzTrials last refreshed its copy on 2 Nov 2026.