A Randomized Multicenter Phase II Trial to Evaluate the Safety, Efficacy and Immunogenicity of Vaccination With Folate Receptor Alpha Peptides With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer and a Response or Stable Disease to Platinum Therapy
Phase of Trial: Phase II
Latest Information Update: 15 Nov 2017
At a glance
- Drugs TPIV 200 (Primary)
- Indications Ovarian cancer
- Focus Therapeutic Use
- Sponsors TapImmune
- 15 Nov 2017 According to a TapImmune media release, the company is currently enrolling women who have completed initial therapy with a platinum regimen and are in first remission. Enrollment remains on track with projections and the company plans to conduct a blinded interim safety and futility analysis once the data from the first half of enrollment is achieved and responses mature, which is currently expected in early 2019.
- 08 Aug 2017 According to a TapImmune media release, the company in coordination with the US FDA has amended the patient inclusion criteria to focus on women with Stage III and IV ovarian cancer who are in remission following their first round of successful platinum-based chemotherapy.
- 09 May 2017 Planned number of patients changed from 80 to 120.