‘Rollover’ Trial to Test Breast Cancer Vaccine, BriaVax, in Combo with Yervoy or Keytruda

‘Rollover’ Trial to Test Breast Cancer Vaccine, BriaVax, in Combo with Yervoy or Keytruda
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
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