A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer

A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer - WT1Ov

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011859

Enrollment

Registered

2013-10-01

Start date

2013-10-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

WT1 peptide-based cancer vaccine is contained 3 kinds of WT1 peptides (np 126: 2.0mg, mp235: 2.0mg, and np332: 2.0mg) and Montanide ISA51 adjuvant. Intradermally injection of WT1 vaccine will be cont

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed ovarian cancer 2) FIGO stage III or IV 3) Received Taxane + Platinum based chemotherapy as neo-adjuvant and/or Adjuvant chemotherapy 4) Complete remission confirmed with radiological evaluations 5) From 28 to 55 days after completion of surgical + chemotherapy 6) ECOG-PS: 0 - 1 7) Age: 20 - 79 years old 8) HLA-A*24:02 and / or HLA-A*02:01 9) no previous history of treatment for other cancers within at least 5 years 10) adequate organ functions Neutrophils > 1,200 Platelets > 75, 000 Hb > 8.5 sCr < 2.0mg/dl T-Bil < 2.0mg/dl AST / ALT < 100 IU/L 11) Informed consent

Exclusion criteria

Exclusion criteria: 1) Residual diseases after surgical and chemotherapy 2) Received intra-peritoneum chemotherapy 3) Active other cancers except for carcinoma in situ treated completely 4) Received Immunosuppresive agents actively at registration 5) Received Growth factor, including G-CSF, Epo, TPO, within 14 days before registration 6) Received other tested agents within 28 days before registration 7) Received WT1 vaccine 8) Past history of Myeloproliferative diseases, MSD 9) Past history of pulmonary fibrosis, interstitial pneumonitis 10) Past history of autoimmune diseases, including collagen diseases 11) Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on 12) active infectious diseases 13) Past history of HIV, HBV, and HCV infections 14) Grade 3 or severer Neutopatic complications 15) Hypersensitivity to some drugs 16) Pregnancy / lactation 17) Severe Psychological Problems 18) Other severe problems unsuitable for this study

Design outcomes

Primary

Measure	Time frame
2-year disease free survival rate	—

Secondary

Measure	Time frame
overall survival, antigen-specific immunity, safety, and so on	—

Countries

Japan

Contacts

Public ContactSumiyuki Nishida

Osaka university graduate school of medicine Cancer Immunotherapy

clinical-trial@cit.med.osaka-u.ac.jp06-6879-3676

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026