Clinical trial · Interventional
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
NCT02019524CI-TRIAL-00044105J65completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted to HLA-A2+ patients (approximately 50% of the U.S. population).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E39 peptide vaccine | Biological | — | UNRESOLVED |
| E39 vaccine then J65 vaccine | Biological | — | UNRESOLVED |
| J65 vaccine then E39 vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- E39 peptide vaccine
- description
- Patients receive 6 monthly injections of E39 peptide + GM-CSF. Immunologic data is assessed at 1 month and 6 months (+/- 2 weeks) after the primary vaccine series (PVS), specifically ex vivo immunologic recognition of E39 and J65 is assessed by clonal expansion using a dextramer assay and the in vivo response is assessed by delayed type hypersensitivity. The 6-month post-PVS immunologic data is then used to assess each patient for significant residual immunity. Patients are then sorted into two groups: those with SRI and those without. Patients within each group will be randomized to receive 1 booster inoculation of the J65 vaccine or the E39 vaccine. Patients return to the clinic within 1-2 weeks of their 6-month post-PVS visit to receive their booster inoculation.
- interventionNames
- Biological: E39 peptide vaccine
- type
- EXPERIMENTAL
- label
- E39 vaccine then J65 vaccine
- description
- Patients receive 3 inoculations with the E39 vaccine followed by 3 inoculations with the J65 vaccine. Immunologic data is assessed at 1 month and 6 months (+/- 2 weeks) after the primary vaccine series (PVS), specifically ex vivo immunologic recognition of E39 and J65 is assessed by clonal expansion using a dextramer assay and the in vivo response is assessed by delayed type hypersensitivity. The 6-month post-PVS immunologic data is then used to assess each patient for significant residual immunity. Patients are then sorted into two groups: those with SRI and those without. Patients within each group will be randomized to receive 1 booster inoculation of the J65 vaccine or the E39 vaccine. Patients return to the clinic within 1-2 weeks of their 6-month post-PVS visit to receive their booster inoculation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have breast or ovarian cancer 2. Patients must have completed primary breast or ovarian cancer therapy (i.e., surgery, chemotherapy, immunotherapy and/or radiation therapy as appropriate per standard of care for patient's specific cancer) 3. Patients must be without evidence of residual disease as assessed by their treatment team 4. Patients must be either post-menopausal or surgically post-menopausal 5. Patients must be HLA-A2 positive 6. Patients must have a good performance status (ECOG\<2) Exclusion Criteria: 1. HLA-A2 negative patients 2. Currently receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate 3. In poor health (Karnofsky \<60%, ECOG \>2) 4. Total bilirubin \>1.5, creatinine \>2, hemoglobin \<10, platelets \<50,000, WBC \<2,000 5. Active pulmonary disease requiring medication to include multiple inhalers 6. Of child-bearing age with intact reproductive organs 7. Involved in other experimental protocols (except with permission of the other study PI) 8. History of autoimmune disease
References
Publications (1)
- DERIVEDVreeland TJ, Litton JK, Qiao N, Philips AV, Alatrash G, Hale DF, Jackson DO, Peace KM, Greene JM, Berry JS, Clifton GT, Peoples GE, Mittendorf EA. Phase Ib trial of folate binding protein (FBP)-derived peptide vaccines, E39 and an attenuated version, E39': An analysis of safety and immune response. Clin Immunol. 2018 Jul;192:6-13. doi: 10.1016/j.clim.2018.03.010. Epub 2018 Mar 21. PMID 29574039