Discontinuation criteria - Investigational product | |
---|---|
1 Patient weight falls to 30 kg or less. | |
2 Withdrawal of consent to participate in the study or lost to follow-up. | |
3 Withdrawal of consent for further treatment with investigational product. | |
4 Adverse event that, in the opinion of the investigator or the sponsor, contraindicates further dosing. | |
5 Patient who will probably meet one or more exclusion criteria at study entry, to whom pursuing investigational therapy might constitute a safety risk. | |
6 Pregnancy or intent to become pregnant. | |
7 Any AE that meets discontinuation criteria. | |
8 Grade ≥ 3 infusion reaction to durvalumab or tremelimumab. | |
9 Patient non-compliance that, in the opinion of the investigator or sponsor, warrants withdrawal. | |
10 Initiation of alternative anticancer therapy including another investigational agent. | |
11 Confirmation of PD and no benefit from treatment with olaparib or durvalumab + tremelimumab. | |
12 Bone marrow findings consistent with MDS/AML. |