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: 08 Aug 2017
At a glance
- Drugs TPIV 200 (Primary)
- Indications Ovarian cancer
- Focus Therapeutic Use
- Sponsors TapImmune
- 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.
- 14 Mar 2017 According to TapImmune media release, the company expects to complete enrollment mid 2019 and an interim analysis is planned based upon 50% patient enrollment, which the company anticipates completing in the second half of 2018.