RAMPART is an investigator-led international phase three trial, which is evaluating adjuvant durvalumab alone or in combination with tremelimumab in resected renal cell carcinoma. And that combination of durvalumab and tremelimumab has already shown disease-free survival benefit, but obviously any treatment needs to be evaluated for its impact on quality of life. And so we had an optional sub-study embedded within Rampart and the patient-reported outcomes from that to what we’re presenting at GU ASCO...
RAMPART is an investigator-led international phase three trial, which is evaluating adjuvant durvalumab alone or in combination with tremelimumab in resected renal cell carcinoma. And that combination of durvalumab and tremelimumab has already shown disease-free survival benefit, but obviously any treatment needs to be evaluated for its impact on quality of life. And so we had an optional sub-study embedded within Rampart and the patient-reported outcomes from that to what we’re presenting at GU ASCO. Just to tell you, first of all, when we measured the quality of life. So we did that at baseline, at week 16 and at month 15, and we evaluated a number of different areas. So overall health and quality of life, the five different functional domains and nine symptoms and single item scales. In terms of those two different time points, we saw different things. So at that early phase at week 16, we saw a worsening in quality of life, kind of across the board, but the clinically significant and statistically significant findings were worsening in overall health and quality of life, role functioning, fatigue and insomnia. And then at month 15, those largely improved, but we did see some new late emerging effects in self-reported cognitive function and also in pain as well.
This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.