Clinical trial · Interventional
A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant With Ovarian, Tubal or Peritoneal Cancer
A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA-51) as Consolidation Following Optimal Debulking and Systemic Chemotherapy for Women With Advanced Stage Ovarian, Tubal, or Peritoneal Cancer
- 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 study will evaluate the safety of administering a peptide vaccine consisting of twelve different tumor-rejection antigens known to be present on ovarian tumor cells. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.HLA-A2+ is a required criteria for subject eligibility.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian, Tubal or Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tumor peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tumor peptide vaccine
- description
- 2 cohorts: High and low dose tumor peptide vaccine
- interventionNames
- Biological: tumor peptide vaccine
Primary outcomes (1)
- measure
- Date of first objective finding will be used to define the date of relapse
- timeFrame
- From date of enrollment to date of confirmed relaspe
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Must be HLA-A2+ patients with histologically confirmed, stage III-IV epithelial ovarian, tubal, or peritoneal cancer who have undergone optimal debulking and had a complete clinical response to front-line platin/taxane based chemotherapy. * Subjects must have received front-line platin compound and taxane chemotherapy following primary surgical resection. Front-line treatment can include up to 12 cycles of treatment.Subjects must receive the first dose of study medication at least 4 weeks and up to 6 months since completing their last dose of front-line chemotherapy.A complete clinical response defined as: no evidence of disease on physical exam,CT imaging scans of the abdomen and pelvis, chest x-ray and a CA-125 below the upper limit of normal. Exclusion Criteria: * History of autoimmune disease, serious intercurrent chronic or acute illness, active hepatitis, serologic evidence for HIV, splenectomy, or be receiving steroid or immunosuppressive therapy.
References
Publications (1)
- RESULTMorse MA, Secord AA, Blackwell K, Hobeika AC, Sinnathamby G, Osada T, Hafner J, Philip M, Clay TM, Lyerly HK, Philip R. MHC class I-presented tumor antigens identified in ovarian cancer by immunoproteomic analysis are targets for T-cell responses against breast and ovarian cancer. Clin Cancer Res. 2011 May 15;17(10):3408-19. doi: 10.1158/1078-0432.CCR-10-2614. Epub 2011 Feb 7. PMID 21300761