A “rollover” clinical trial of BriaVax — used in combination with Keytruda (pembrolizumab) or Yervoy (ipilimumab) — will soon begin to treat women with advanced breast cancer who did not respond to the investigative vaccine alone in a separate clinical study, BriaVax’s developer, BriaCell Therapeutics, reported.
Women whose cancers continued to progress will be enrolled in the new Phase 1/2 clinical trial (NCT03328026), approved for rollover by the U.S. Food and Drug Administration (FDA). All failed to respond to BriaVax monotherapy in a separate and ongoing Phase 1/2 trial.
Scientists think a combination approach — adding either Yervoy by Bristol-Myers Squibb or Keytruda by Merck — will improve the potential vaccine’s activity against breast tumors.
Not yet open for enrollment, the rollover will likely recruit patients from the other clinical trial (NCT03066947), which is evaluating BriaVax alone to treat metastatic or locally recurrent breast cancers at sites in California, Florida and Washington State. Early results are expected in early 2018.
Women whose cancers express the proteins PD-L1 or PD-L2 will be given Keytruda in combination with BriaVax, while those whose cancers are negative for these proteins will receive Yervoy. The two approved cancer treatments are checkpoint inhibitors, and either combination of therapy will be given in three-week cycles. Treatment safety as well as effectiveness will be evaluated every two to three weeks, and imaging assessments will be conducted every eight to 12 weeks.
As in the monotherapy study, patients will also be treated with a chemotherapy, cyclophosphamide, at a low dose.
BriaVax is a vaccine that consists of whole cells that are genetically engineered to release a protein, called granulocyte-macrophage colony-stimulating factor (GM-CSF), that activates the immune system.
In an earlier and small Phase 1 study, BriaVax induced a quick and near complete regression of metastatic breast cancer deposits in the breast, lung, soft tissue, and brain, BriaCell reported.
“We are very excited to evaluate the effects of BriaVax with other approved anti-tumor immunotherapeutic agents. We expect this study to extend and potentiate the clinical benefits of BriaVax in advanced breast cancer patients,” William Williams, BriaCell’s president & CEO, said in a press release. “We look forward to expanding our clinical study … and we are pleased with the FDA decision.”
The company announced that is co-developing BriaDx, a diagnostic tool to identify patients who respond to BriaVax, in conjunction with the monotherapy trial’s results.