TumorsPhase 1NCT00299728
NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors
A Phase 1 study testing NY-ESO-1 Protein Vaccine in people with Tumors, run by Ludwig Institute for Cancer Research at 2 sites in United States.
Trial summary
This is a Phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1. The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- NY-ESO-1 Protein Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2006to 10 Jan 2014
- Phase
- Phase 1
- 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
- Histological diagnosis of hepatocellular carcinoma, bladder cancer, breast cancer, non-small lung cancer (NSCLC), melanoma, sarcoma, prostate cancer, esophageal cancer, or ovarian cancer, independent of NY-ESO-1 expression in a tumor biopsy.
- or
- Histological diagnosis of other types of cancers, provided NY-ESO-1 or LAGE-1 expression can be shown in a tumor biopsy.
- At least 4 weeks since surgery prior to first dosing of study agent.
- Laboratory values within the following limits:
- Hemoglobin ≥ 11.0 g/dL
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- Neutrophil count ≥ 1.5 x l0^9/L
- Lymphocyte count ≥ lower limit of institutional normal
- Platelet count ≥ 80 x l0^9/L
- Serum creatinine ≤ 2.0 mg/dL
- Serum bilirubin ≤ 2 x upper limit of institutional normal
- AST/ALT ≤ 2 x upper limit of institutional normal
- Patients must have a Karnofsky performance status of ≥70%.
- Life expectancy ≥ 6 months.
- Age ≥ 18 years.
- Able and willing to give witnessed, written informed consent for participation in the trial.
Who cannot join
- Clinically significant heart disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
- Previous bone marrow or stem cell transplant.
- History of immunodeficiency disease or autoimmune disease except vitiligo.
- Metastatic disease to the central nervous system, unless treated and stable.
- Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ.
Show all 14Show fewer
- Known HIV, Hepatitis B or Hepatitis C positivity.
- Chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to first dose of study agent (6 weeks for nitrosoureas).
- Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
- Pregnancy or lactation.
- Women of childbearing potential not using a medically acceptable means of contraception.
- Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- Lack of availability of the patient for immunological and clinical follow-up assessment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Clinical Cancer Center
New York, New York, 10016
NY Presbyterian- Columbia
New York, New York, 10032
About this study
Official title: A Phase I Study Using Vaccination With NY-ESO-1 Recombinant Protein Mixed With CpG 7909 and Montanide ISA-51 VG in Patients With Cancers That Often Express NY-ESO-1.
This is a Phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1.
The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses.
Read more
Patients with any malignancy that is known to frequently express NY-ESO-1 were eligible, regardless of whether antigen expression in the autologous tumor could be demonstrated or not by either PCR or immunohistochemistry.
The primary objective of the study was to define safety.
Secondarily, the study was to evaluate whether patients developed a specific immunologic response to the NY-ESO-1 protein. Blood samples were to be obtained at baseline, prior to each vaccination, one week after each vaccination, and at the last study visit for the assessment of NY-ESO-1-specific CD4+ and CD8+ T cells. Cytokine secretion by NY-ESO-1-specific CD8+ and CD4+ T cells, as a measure of T cell activation, was to be determined by FACS analysis. In addition, humoral immunity was to be determined by the presence of NY-ESO-1-specific antibodies which were to be assessed in all patients by ELISA.
Disease status was to be assessed at baseline and 2-4 weeks after the fourth vaccination in patients with evaluable (measurable and non-measurable) disease.
Read the detailed description
Subjects were to receive an investigational (research) cancer vaccine every 3 weeks for a total of 4 treatments. It was given by injection underneath the skin in an extremity (leg or arm). A vaccine is a compound designed to strengthen the immune system (the cells and substances that protect the body from infection and foreign matter) to fight an illness such as infections or cancer. This vaccine is called NY-ESO-1 protein. NY-ESO-1 protein (an antigen, which is a compound that is recognized by the immune system) is found in many cancers. Proteins such as NY-ESO-1 and their fragments are the targets the immune system needs to recognize cancer cells. If the immune system can recognize these antigens (foreign substances) it may be able to kill the cells that carry them. NY-ESO-1 can be found at different stages of cancers, and is likely to be expressed (shown) at some point in the lifecycle of these types of cancer (that are eligible for this study). Therefore this study tries to boost (strengthen) the immune system toward NY-ESO-1 protein regardless of whether it is found in your tumor or not.
Since we do not know whether different doses of the NY-ESO-1 protein may result in varying degrees of immune stimulation, we will be randomizing (that is, at the flip of a coin or, in other words, by chance). You may receive either the lower dose of NY-ESO-1 protein (100 µg) or the higher dose (400 µg).
The NY-ESO-1 protein vaccine was to be mixed with 2 substances, called adjuvants (the full names are: CPG 7909 and Montanide ISA-51 VG). Adjuvants are substances to increase the vaccine's ability to stimulate the immune system. By adding two adjuvants to the vaccine, it is hoped that the boosting of the immune system will be especially effective.
It is important to understand, that vaccines are only experimental (investigational, research) for the treatment of cancer. They are not approved by the Food and Drug Administration (FDA) as treatment. Therefore they are only offered in clinical trials.
All tests and treatments were performed as an outpatient.
- Conditions
- Tumors
- Being tested
- NY-ESO-1 Protein Vaccine
- Keywords
- NY-ESO-1, Vaccine, Adjuvant or metastatic setting, Several tumor types eligible
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NY-ESO-1 Protein VaccineBiological
NY-ESO-1 recombinant protein mixed with CpG 7909 and Montanide ISA-51 VG
| Study group | Role | What they receive |
|---|---|---|
| Arm A; 100 μg NY-ESO-1 protein co-mixed with CpG 7909 and Montanide ISA-51 VG | Experimental | 100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10). Receives: Biological: NY-ESO-1 Protein Vaccine |
| Arm B; 400 μg NY-ESO-1 protein co-mixed with CpG 7909 and Montanide ISA-51 VG | Experimental | 400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10). Receives: Biological: NY-ESO-1 Protein Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Adverse Events (AEs) and Dose-limiting Toxicities (DLTs)
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
DLT was defined as ≥ Grade 3 hematological and non-hematological toxicities or ≥ Grade 2 allergic reaction for generalized urticaria that was definitely, probably, or possibly related to the administration of the NY-ESO-1 protein vaccine.
Measured: up to 14 weeks
Number of Subjects With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
Blood samples were taken at baseline and in weeks 2, 4, 5, 7, 8, 10, 11, and 12-14 for the assessment of NY-ESO-1-specific antibodies by an enzyme-linked immunosorbent assay (ELISA). Sera were assessed over a range of dilutions from 1/100 to 1/100,000. Titers were calculated as the serum dilution giving 50% of maximal optical density obtained by using a standard positive serum. Positive results were reciprocal serum titers greater than 100.
Measured: Up to 14 weeks
Secondary outcomes (3)
Number of Subjects With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Computed tomography (CT) or magnetic resonance imaging (MRI) scans were performed at screening and weeks 12-14 and 16-18, and tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) according to Therasse P et al. 2000.
Per RECIST, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria; no evidence of disease (NED): no evidence of disease at baseline and post-baseline assessments.
Measured: up to 18 weeks
Number of Subjects With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ T Cells After in Vitro Stimulation
Blood samples were taken at baseline and in weeks 2, 4, 5, 7, 8, 10, 11, 12-14, 16-18, 20-22, 24-26, and 28-32. Subjects were consented separately for blood draws after week 14. The induction of specific T cells was assessed after in vitro stimulation of pre- and post-treatment samples with a pool of overlapping peptides spanning the protein sequence, followed by quantification of specific IFN-γ-producing cells by intracellular staining. The response was considered significant if the frequency of T cells detected in at least one post-treatment sample exceeded by 3-fold that found in the baseline sample.
Measured: up to 32 weeks
Number of Subjects With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO--Specific CD8+ T Cells After in Vitro Stimulation
Blood samples were taken at baseline and in weeks 2, 4, 5, 7, 8, 10, 11, 12-14, 16-18, 20-22, 24-26, and 28-32. Subjects were consented separately for blood draws after week 14. The induction of specific T cells was assessed after in vitro stimulation of pre- and post-treatment samples with a pool of overlapping peptides spanning the protein sequence, followed by quantification of specific IFN-γ-producing cells by intracellular staining. The response was considered significant if the frequency of T cells detected in at least one post-treatment sample exceeded by 3-fold that found in the baseline sample.
Measured: up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study start21 Mar 2006
- Primary completion10 Oct 2006
- Study completion10 Jan 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Institute for Cancer Research
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Nina Bhardwaj, MD, PhD, Principal investigator, NYU Langone HealthSylvia Adams, MD, Study director, NYU Langone HealthGregory Mears, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299728
- Sponsor's protocol ID
- LUD2003-022;NYU05-120;CUMC9147
- Status last verified
- Oct 2022
- First submitted
- 6 Mar 2006
- Last updated
- 10 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
PubMed 10655437Valmori D, Souleimanian NE, Tosello V, Bhardwaj N, Adams S, O'Neill D, Pavlick A, Escalon JB, Cruz CM, Angiulli A, Angiulli F, Mears G, Vogel SM, Pan L, Jungbluth AA, Hoffmann EW, Venhaus R, Ritter G, Old LJ, Ayyoub M. Vaccination with NY-ESO-1 protein and CpG in Montanide induces integrated antibody/Th1 responses and CD8 T cells through cross-priming. Proc Natl Acad Sci U S A. 2007 May 22;104(21):8947-52. doi: 10.1073/pnas.0703395104. Epub 2007 May 15.
PubMed 17517626
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Using Vaccination With NY-ESO-1 Recombinant Protein Mixed With CpG 7909 and Montanide ISA-51 VG in Patients With Cancers That Often Express NY-ESO-1.
- ClinicalTrials.gov ID
- NCT00299728
- Acronym / sponsor ID
- LUD2003-022;NYU05-120;CUMC9147
- Conditions
- Tumors
- Keywords
- NY-ESO-1, Vaccine, Adjuvant or metastatic setting, Several tumor types eligible
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ludwig Institute for Cancer ResearchUniversity, hospital or other
- Collaborators
- NYU Langone Health
- Study start
- 21 Mar 2006 (actual)
- Primary completion
- 10 Oct 2006 (actual)
- Study completion
- 10 Jan 2014 (actual)
- First posted
- 7 Mar 2006 (estimated)
- Results
- Posted 26 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1.
The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses.
Patients with any malignancy that is known to frequently express NY-ESO-1 were eligible, regardless of whether antigen expression in the autologous tumor could be demonstrated or not by either PCR or immunohistochemistry.
The primary objective of the study was to define safety.
Secondarily, the study was to evaluate whether patients developed a specific immunologic response to the NY-ESO-1 protein. Blood samples were to be obtained at baseline, prior to each vaccination, one week after each vaccination, and at the last study visit for the assessment of NY-ESO-1-specific CD4+ and CD8+ T cells. Cytokine secretion by NY-ESO-1-specific CD8+ and CD4+ T cells, as a measure of T cell activation, was to be determined by FACS analysis. In addition, humoral immunity was to be determined by the presence of NY-ESO-1-specific antibodies which were to be assessed in all patients by ELISA.
Disease status was to be assessed at baseline and 2-4 weeks after the fourth vaccination in patients with evaluable (measurable and non-measurable) disease.
Detailed description
Subjects were to receive an investigational (research) cancer vaccine every 3 weeks for a total of 4 treatments. It was given by injection underneath the skin in an extremity (leg or arm). A vaccine is a compound designed to strengthen the immune system (the cells and substances that protect the body from infection and foreign matter) to fight an illness such as infections or cancer. This vaccine is called NY-ESO-1 protein. NY-ESO-1 protein (an antigen, which is a compound that is recognized by the immune system) is found in many cancers. Proteins such as NY-ESO-1 and their fragments are the targets the immune system needs to recognize cancer cells. If the immune system can recognize these antigens (foreign substances) it may be able to kill the cells that carry them. NY-ESO-1 can be found at different stages of cancers, and is likely to be expressed (shown) at some point in the lifecycle of these types of cancer (that are eligible for this study). Therefore this study tries to boost (strengthen) the immune system toward NY-ESO-1 protein regardless of whether it is found in your tumor or not.
Since we do not know whether different doses of the NY-ESO-1 protein may result in varying degrees of immune stimulation, we will be randomizing (that is, at the flip of a coin or, in other words, by chance). You may receive either the lower dose of NY-ESO-1 protein (100 µg) or the higher dose (400 µg).
The NY-ESO-1 protein vaccine was to be mixed with 2 substances, called adjuvants (the full names are: CPG 7909 and Montanide ISA-51 VG). Adjuvants are substances to increase the vaccine's ability to stimulate the immune system. By adding two adjuvants to the vaccine, it is hoped that the boosting of the immune system will be especially effective.
It is important to understand, that vaccines are only experimental (investigational, research) for the treatment of cancer. They are not approved by the Food and Drug Administration (FDA) as treatment. Therefore they are only offered in clinical trials.
All tests and treatments were performed as an outpatient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A; 100 μg NY-ESO-1 protein co-mixed with CpG 7909 and Montanide ISA-51 VG | Experimental | Biological: NY-ESO-1 Protein Vaccine100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10). |
| Arm B; 400 μg NY-ESO-1 protein co-mixed with CpG 7909 and Montanide ISA-51 VG | Experimental | Biological: NY-ESO-1 Protein Vaccine400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histological diagnosis of hepatocellular carcinoma, bladder cancer, breast cancer, non-small lung cancer (NSCLC), melanoma, sarcoma, prostate cancer, esophageal cancer, or ovarian cancer, independent of NY-ESO-1 expression in a tumor biopsy.
- or
- Histological diagnosis of other types of cancers, provided NY-ESO-1 or LAGE-1 expression can be shown in a tumor biopsy.
- At least 4 weeks since surgery prior to first dosing of study agent.
- Laboratory values within the following limits:
Key exclusion criteria (14 listed)
- Clinically significant heart disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
- Previous bone marrow or stem cell transplant.
- History of immunodeficiency disease or autoimmune disease except vitiligo.
- Metastatic disease to the central nervous system, unless treated and stable.
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 |
|---|---|---|
| NY-ESO-1 Protein VaccineNY-ESO-1 recombinant protein mixed with CpG 7909 and Montanide ISA-51 VG | Biological | Arm A; 100 μg NY-ESO-1 protein co-mixed with CpG 7909 and Montanide ISA-51 VG, Arm B; 400 μg NY-ESO-1 protein co-mixed with CpG 7909 and Montanide ISA-51 VG |
Primary outcome
Number of Subjects Reporting Adverse Events (AEs) and Dose-limiting Toxicities (DLTs)
Time frame: up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0). DLT was defined as ≥ Grade 3 hematological and non-hematological toxicities or ≥ Grade 2 allergic reaction for generalized urticaria that was definitely, probably, or possibly related to the administration of the NY-ESO-1 protein vaccine.
Number of Subjects With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
Time frame: Up to 14 weeks
Blood samples were taken at baseline and in weeks 2, 4, 5, 7, 8, 10, 11, and 12-14 for the assessment of NY-ESO-1-specific antibodies by an enzyme-linked immunosorbent assay (ELISA). Sera were assessed over a range of dilutions from 1/100 to 1/100,000. Titers were calculated as the serum dilution giving 50% of maximal optical density obtained by using a standard positive serum. Positive results were reciprocal serum titers greater than 100.
3 secondary outcomes
Number of Subjects With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: up to 18 weeks
Number of Subjects With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ T Cells After in Vitro Stimulation
Time frame: up to 32 weeks
Number of Subjects With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO--Specific CD8+ T Cells After in Vitro Stimulation
Time frame: up to 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10655437Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
- Results publication: PubMed 17517626Valmori D, Souleimanian NE, Tosello V, Bhardwaj N, Adams S, O'Neill D, Pavlick A, Escalon JB, Cruz CM, Angiulli A, Angiulli F, Mears G, Vogel SM, Pan L, Jungbluth AA, Hoffmann EW, Venhaus R, Ritter G, Old LJ, Ayyoub M. Vaccination with NY-ESO-1 protein and CpG in Montanide induces integrated antibody/Th1 responses and CD8 T cells through cross-priming. Proc Natl Acad Sci U S A. 2007 May 22;104(21):8947-52. doi: 10.1073/pnas.0703395104. Epub 2007 May 15.
- 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.
Nina Bhardwaj, MD, PhD principal investigator
NYU Langone Health
Sylvia Adams, MD study director
NYU Langone Health
Gregory Mears, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NY-ESO-1 Protein Vaccine in people with Tumors, run by Ludwig Institute for Cancer Research at 2 sites 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 16 inclusion and 14 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 10 Oct 2022. 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 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?
Yes. Results are posted in the registry (first posted 26 Nov 2021). 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?
Number of Subjects Reporting Adverse Events (AEs) and Dose-limiting Toxicities (DLTs) (time frame: up to 14 weeks). 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 NCT00299728, which also lists 2 linked publications.
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 10 Oct 2022.