While the study initially aimed to enroll 80 patients, it is now recruiting 120 patients with platinum-sensitive advanced ovarian cancer (stage III and IV) who completed a single round of platinum-based chemotherapy. Previously, patients were required to have had no less than four cycles of this chemotherapy.
The larger number of participants will allow researchers to better evaluate the effects of TPIV 200 as a potential maintenance therapy to prevent disease recurrence, since more participants mean more robust statistical analyses.
TapImmune’s decision came after discussion with its clinical advisers; talks highlighted the current lack of a maintenance therapy aiming to prevent ovarian cancer from coming back after patients achieve a first remission.
“Our investigators, as well as their ovarian cancer patients, are enthusiastic about this trial, which is intended to demonstrate enhanced progression-free survival for women prior to their first recurrence,” Dr. Richard Kenney, head of clinical development at TapImmune, said in a press release.
“Shifting our focus to earlier in the treatment cycle enables TapImmune to showcase the potential of our novel T cell vaccine in a much larger patient population. Furthermore, should TPIV 200 demonstrate a significant benefit for these women in prolonging the time to disease recurrence, the company will be well positioned within the current treatment paradigm for ovarian cancer, which now includes the PARP inhibitor niraparib for treating patients with recurrent disease,” Kenney added.
Patients recruited to the Phase 2 trial (NCT02978222) will be randomly assigned to either receive either adjuvant TPIV 200 vaccine along with an immune system stimulant GM-CSF, or GM-CSF adjuvant alone. An adjuvant treatment is one that is given following the primary treatment — chemotherapy, in this trial — and that aims to lower the risk of the cancer coming back.
The study is taking place at the Sarah Cannon Research Institute in Nashville, Tennessee. Enrollment and other information is available by clicking on the study’s identification number, above.
TPIV 200 targets a protein, called folate receptor alpha, which is highly expressed in patients with ovarian cancer. In previous Phase 1 studies with ovarian and breast cancer patients, the vaccine showed to induce long-lasting immune responses. Trial results are expected by December 2020.