Clinical trial · Interventional
Ovarian Cancer Vaccine for Patients in Remission
A Randomized, Open-label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac™) for Epithelial Ovarian Cancer Patients in First or Second Remission
- 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)
The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning. Study objectives Primary objectives: * To confirm the safety of administering Cvac in this population. * To determine the effects of Cvac on progression-free survival (PFS). Secondary objectives: * To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting. * Evaluation of host immunologic response to Cvac administration.
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 Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cvac | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Non-randomized Cvac
- description
- Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained \~ 60 × 10\^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
- interventionNames
- Biological: Cvac
- type
- EXPERIMENTAL
- label
- Randomized Cvac
- description
- Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained \~ 60 × 10\^6 dendritic cells.
- interventionNames
- Biological: Cvac
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in complete remission (based on clinical and radiologic studies). * Cancer antigen (CA)-125 ≤ upper limit of normal with a prior history of an elevated CA-125. * Able and willing to undergo mononuclear cell collection. * Not more than 12 weeks between enrollment and the last dose of chemotherapy that resulted in complete remission. * No prior surgery to the peritoneum or pleural space within 28 days of enrollment, excluding removal of catheters used for chemotherapy administration. * No prior treatment with an investigational product within 30 days of enrollment. * Baseline electrocardiogram within normal limits or any abnormalities deemed not indicative of cardiac disease for which intervention is required. * Serum creatinine ≤ 2 mg/dL. * Serum aspartate aminotransferase or serum alanine aminotransferase ≤ 2.5x the upper limit of normal or serum total bilirubin ≤ 1.5x the upper limit of normal. * White blood cell count ≥ 3.0 K/µL; absolute neutrophil count ≥ 1.5K/µL; hemoglobin ≥ 9.0 g/dL, and platelets ≥ 100,000/mm\^3. (These complete blood count results are required for enrollment. It should be noted that complete blood count results, including monocyte count ≥ 0.2 × 10\^9/L, will be needed prior to leukapheresis to determine if sufficient dendritic cells can be obtained for Cvac™ manufacture.) * Life expectancy of at least 12 months. * Eastern Cooperative Oncology Group Performance Status of 0-1. * All toxicities from prior therapies, excluding alopecia, must have resolved to Common Terminology Criteria for Adverse Events Grade ≤ 1. * Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion. * Able to provide written informed consent. Exclusion Criteria: * Coexisting or other malignancies unless in complete remission for not less than 3 years. Does not include in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin for which no restrictions apply, assuming they have been adequately treated. * Ovarian germ cell, sarcoma, or mixed Mullerian tumors. * Prior cancer vaccine or cellular therapy. * Active uncontrolled infections or any organ system toxicity ≥ Grade 2 by Common Terminology Criteria for Adverse Events criteria. * Inability to provide informed consent or to comply with study-related procedures. * Concurrent systemic treatment with steroids or other immunosuppressive agents. * Diagnosed immunodeficiency and/or autoimmune disorders. * Myocardial infarction in the past 6 months and/or clinically significant heart disease. * Infection with human immunodeficient virus (HIV), hepatitis B or C virus. * Pregnant or breastfeeding. * Evidence or history of central nervous system metastases. * Full dose anticoagulation therapy administered within 7 days of leukapheresis procedure. * Hematopoietic growth factors administered within 14 days of enrollment.
References
Publications (16)
- BACKGROUNDJemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20. PMID 18287387
- BACKGROUNDGrossi M, Quinn MA, Thursfield VJ, Francis PA, Rome RM, Planner RS, Giles GG. Ovarian cancer: patterns of care in Victoria during 1993-1995. Med J Aust. 2002 Jul 1;177(1):11-6. doi: 10.5694/j.1326-5377.2002.tb04616.x. PMID 12088472
- BACKGROUNDOzols RF, Rubin SC, Thomas G, et al. Epithelial ovarian cancer. In: Hoskins WJ, Perez CA, Young RC, eds. Principles and Practice of Gynecologic Oncology, 4th ed. Philadelphia: Lippincott Williams & Wilkins. 2005:919-922.
- BACKGROUNDMarkman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460-5. doi: 10.1200/JCO.2003.07.013. PMID 12829663
- BACKGROUNDApostolopoulos V, McKenzie IF. Cellular mucins: targets for immunotherapy. Crit Rev Immunol. 1994;14(3-4):293-309. doi: 10.1615/critrevimmunol.v14.i3-4.40. PMID 7538768
- BACKGROUNDDesai J, Mitchell P, Loveland B, et al. A phase I trial of dendritic cells pulsed with MUC1 peptide in patients with solid tumours. Proc ASCO 2002; 21:15b (A1868).
- BACKGROUNDRustin GJ, Nelstrop AE, Bentzen SM, Bond SJ, McClean P. Selection of active drugs for ovarian cancer based on CA-125 and standard response rates in phase II trials. J Clin Oncol. 2000 Apr;18(8):1733-9. doi: 10.1200/JCO.2000.18.8.1733. PMID 10764434
- BACKGROUNDApostolopoulos V, McKenzie IF, Pietersz GA. Breast cancer immunotherapy: current status and future prospects. Immunol Cell Biol. 1996 Oct;74(5):457-64. doi: 10.1038/icb.1996.76.