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Table 3 Criteria for permanent discontinuation of investigational product

From: Precision medicine phase II study evaluating the efficacy of a double immunotherapy by durvalumab and tremelimumab combined with olaparib in patients with solid cancers and carriers of homologous recombination repair genes mutation in response or stable after olaparib treatment

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.