Clinical trial · Interventional
Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer
Phase I/IIa Trial of Folate Binding Protein (FBP) Peptide (E39) Vaccine in Ovarian and Endometrial Cancer Patients
- 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)
Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The purpose of this study is to test whether a peptide-based vaccine consisting of the E39 peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune response. Furthermore, the investigators intend to determine the best dose of the vaccine to utilize to produce this immunity most efficiently. The investigators will determine whether immunity to FBP will prevent clinical recurrence. Additionally, the investigators will compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu protein) in ovarian and endometrial cancer patients in preparation for studying a combination vaccine.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Cancer | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E39 peptide (1000mcg)/GM-CSF vaccine plus E39 booster | Biological | — | UNRESOLVED |
| E39 peptide (1000mcg)/GM-CSF vaccine plus J65 booster | Biological | — | UNRESOLVED |
| E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster | Biological | — | UNRESOLVED |
| E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster | Biological | — | UNRESOLVED |
| E39 peptide (500mcg)/GM-CSF vaccine plus E39 booster | Biological | — | UNRESOLVED |
| E39 peptide (500mcg)/GM-CSF vaccine plus J65 booster | Biological | — | UNRESOLVED |
| Non-vaccine clinically matched control group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- ACTIVE_COMPARATOR
- label
- Non-vaccine clinically matched control group
- description
- HLA-A2-negative patients and HLA-A2+ patients who decline the vaccine will be followed clinically as matched controls for disease recurrence/progression.
- interventionNames
- Other: Non-vaccine clinically matched control group
- type
- EXPERIMENTAL
- label
- E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster
- description
- HLA-A2+ patients receive 100mg E39 peptide/GM-CSF vaccine intradermally every 3-4 weeks for a total of up to six inoculations followed by 500mg booster inoculations of E39 6 and 12 months after completion of the primary vaccine series.
- interventionNames
- Biological: E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients will be included in the study based on the following criteria. (Enrollment may commence 1 month from completion of standard primary therapies and up to two years after completion of treatment.) 1. Ovarian or endometrial, fallopian and peritoneal cancer 2. Completion of primary first-line therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patient's specific cancer) 3. Stage I-IV but no evidence of disease (NED) after completion of primary therapies 4. Post-menopausal or rendered surgically infertile 5. HLA-A2+ patients will receive the vaccine; HLA-A2- patients will be eligible to participate in the control group 6. Good performance status (Karnofsky \> 60%, ECOG ≤ 2) 7. CBC, CMP, and CA-125 within 2 months of enrollment 8. Capable of informed consent Exclusion Criteria: Patients will be excluded from the study based on the following criteria: 1. Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate 2. Not post-menopausal or not rendered surgically infertile 3. Pregnancy 4. In poor health (Karnofsky \< 60%, ECOG \> 2) 5. Tbili \> 1.5, creatinine \> 2, hemoglobin \< 10, platelets \< 50,000, WBC \< 2,000 6. Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease 7. Involved in other experimental protocols (except with permission of the other study PI and completion of the other study dosing regimen) 8. History of autoimmune disease
References
Publications (0)
Data not yet available