Table 1 Eligibility criteria for the IMAGENE trial
Inclusion criteria | Exclusion criteria |
|---|---|
1. Malignant progression after one or more standard therapy with PD-1/PD-L1 inhibitors, and completion of standard therapy in principle | 1. Severe comorbidity a. Synchronous active malignancies b. Uncontrolled brain metastasis or leptomeningeal metastasis c. Active infectious disease d. Uncontrolled ascites, pleural effusion, or pericardial effusion requiring continued drainage e. Uncontrolled diabetes mellitus or hypertension f. Myocardial infarction, severe/unstable angina pectoris, symptomatic congestive heart failure of New York Heart Association Class II—IV within 6 months before enrollment g. Psychiatric diseases or psychiatric symptoms that were considered to cause difficulty in enrollment in a clinical trial |
2. Diagnosed with the target disease (unresectable advanced or recurrent urothelial cancer, renal cell carcinoma, gastric cancer, esophageal cancer, head and neck cancer, malignant melanoma with HRR gene mutation in the germline or somatic cells, which were detected by the specified tests) | 2. Underwent one of the following treatments before protocol treatment: a. Extensive surgery within 4Â weeks b. Colostomy/ileostomy within 2Â weeks c. Chemotherapy within 2Â weeks d. Radiation therapy within 2Â weeks |
3. Measurable lesions | 3. CTCAE Grade 2 adverse events due to previous therapy, which are not recovered |
4. Legal adult on informed consent | 4. History of PARP inhibitor treatments |
5. ECOG PS: 0 or 1 | 5. Intolerant to previous irinotecan therapy |
6. Appropriate physical function confirmed by laboratory values within 14Â days before enrollment | 6. Comorbidity or history of uncontrollable hypertension |
7. (Female of childbearing potential) Agreed to contraception and not to donate oocytes from consent to 180Â days after the last dose of the study drug | 7. Men/women who are unwilling to avoid pregnancy; women who are pregnant or breastfeeding; women with a positive pregnancy test |
8. (Male) Agreed to contraception from the start of study treatment to 180Â days after the last dose of the study drug, and agreed not to donate sperms from the start of study treatment to 90Â days after the last dose of the study drug or 120Â days after the last dose of a PD-1 inhibitor, whichever is later | 8. Known active HCV or HIV infection |
9. Written consent to participate in the clinical trial | 9. Any other patients who are regarded as inadequate for trial enrollment by investigators |