Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04810156
Eligibility Criteria:
Inclusion Criteria:
Cohort A:
\- Abnormal liver parameters equal to ≥ grade 3 ir-hepatitis defined as; AST/ALT/ALP \>5 x ULN, INR ≥ 2.5 x ULN, or bilirubin \> 3.0 x ULN
Cohort B:
\- Patients who recur during or within one months of prednisolone tapering of ≥2 ir-hepatitis equal to AST/ALT ≥3 x ULN, ALP ≥2.5 x ULN, INR ≥ 1.5 x ULN, or bilirubin ≥ 3.0 x ULN
Cohort A and Cohort B
* Histologically confirmed solid cancer
* Treatment with cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) or Programmed Cell Death-1 (PD-1)/Programmed Cell Death Ligand-1 (PD-L1) inhibitor or a combination of CTLA-4 plus PD-1 inhibitors within 6 months
* Age: ≥ 18 years
* Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives
* Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition, documented vasectomy and sterility or double barrier contraception are considered effective contraceptives
* Signed statement of consent after receiving oral and written study information
* Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.
Exclusion Criteria:
* Concomitant chemotherapy treatment or tyrosine kinases or angiogenesis inhibitors
* Concomitant immunosuppressive medication except prednisolone
* Patients with hepatocellular carcinoma
* Known hypersensitivity to one of the active drugs or excipients
* Uncontrolled infection
* Acute viral hepatitis
* Any medical condition that will interfere with patient compliance or safety
* Simultaneous treatment with other experimental drugs or other anticancer drugs
* Pregnant or breastfeeding females
* Phenylketonuria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04810156
Study Brief:
Protocol Section:
NCT04810156