Evaluating treatments for immune-related hepatitis in cancer patients
A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors; Characterization of Liver Injury, Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse
This study is testing whether a new immunosuppressive drug works better than standard steroids for treating liver problems in cancer patients who have had immune therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Herlev, Copenhagen and 4 other locations) |
| Trial ID | NCT04810156 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of corticosteroids and mycophenolate mofetil in treating immune-related hepatitis in patients who have received immune checkpoint inhibitors for cancer. It aims to characterize the liver injury patterns and treatment responses in patients who are steroid-dependent or refractory. The study will compare the outcomes of patients receiving standard steroid treatment versus those receiving a second-line immunosuppressive drug. By understanding these treatment responses, the trial seeks to optimize care for patients experiencing liver complications from cancer therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed solid cancers who have developed immune-related hepatitis after treatment with immune checkpoint inhibitors.
Not a fit: Patients without a confirmed diagnosis of immune-related hepatitis or those who have not received immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment strategy for patients suffering from immune-related hepatitis, potentially improving their overall health outcomes.
How similar studies have performed: While there is limited evidence on the specific combination of treatments being tested, similar studies have shown promise in managing immune-related adverse events in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herlev, Copenhagen and 4 other locations
- Herlev University Hospital — Herlev, Copenhagen, Denmark (Recruiting)
- Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Rikke B Holmstrøm — Ph.D student, National Center for Cancer Immune Therapy, Dept. of Oncology, Hospital Herlev
- Study coordinator: Inge Marie Svane, M.D. Professor
- Email: inge.marie.svane@regionh.dk
- Phone: +38683868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.