Clinical trial · Interventional
Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
Phase 1b Study of Extended Dosing of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube 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)
As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.
Conditions
Conditions (3)
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 Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| DPX-Survivac | Biological | — | UNRESOLVED |
| DPX-Survivac(Aqueous) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
- interventionNames
- Biological: DPX-Survivac
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
- interventionNames
- Biological: DPX-Survivac
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer * Complete or partial response following standard of care surgery and first line chemotherapy * May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment * Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection * Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection * Ambulatory with an ECOG 0-1 * Life expectancy \> 6 months * Meet protocol-specified lab requirements * Provide informed consent and have ability to comply with protocol requirements Key Exclusion Criteria: * Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol) * Prior receipt of survivin based vaccines * Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies * Progressive disease (rising CA-125 acceptable) * More than one course of chemotherapy for recurrent disease * Concurrent bevacizumab as maintenance therapy * Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer * History of autoimmune disease * Recent history of thyroiditis * Presence of a serious acute infection or chronic infection * Brain metastases * Other serious intercurrent chronic or acute illness * Ongoing treatment with steroid therapy or other immunosuppressive * Acute or chronic skin disorders
References
Publications (0)
Data not yet available