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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (MEDIOLA)

Excerpt:
This is a phase I/II open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK) and antitumor activity of MEDI4736 in combination with olaparib in patients with advanced solid tumors, selected based on a rationale for response to olaparib.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

529MO - Phase II study of olaparib plus durvalumab with or without bevacizumab (MEDIOLA): Final analysis of overall survival in patients with non-germline BRCA-mutated platinum-sensitive relapsed ovarian cancer

Published date:
09/05/2022
Excerpt:
Based on the reported final OS and DCR at 56 wks data, treatment with O+D+B demonstrated promising efficacy in pts with non-gBRCAm PSR OC. O+D and O+D+B safety profiles were consistent with that expected for the single agents; no new safety signals emerged with longer follow-up.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

814MO - Phase II study of olaparib (O) plus durvalumab (D) and bevacizumab (B) (MEDIOLA): Initial results in patients (pts) with non-germline BRCA-mutated (non-gBRCAm) platinum sensitive relapsed (PSR) ovarian cancer (OC)

Published date:
09/18/2020
Excerpt:
Combining O+D and O+D+B was well tolerated in pts with non-gBRCAm PSR OC, consistent with the known safety profiles of the single agents. The DCR for the doublet cohort did not meet the prespecified target of 80%. The 95% CI for DCR in the triplet cohort included the prespecified target of 80%. ORR and PFS in the triplet cohort demonstrate promising activity in non-gBRCAm PSR OC, and in this group the ORR and PFS are higher than reported for single-agent PARP or VEGF inhibitors.
Trial ID: