Efficacy of high-dose steroids, mycophenolate mofetil and tacrolimus for treatment of patients with immune related hepatitis induced by cancer immunotherapy

Phase 1

• Conditions: Immune related hepatitis induced by immune checkpoint inhibitor grade III-IV; MedDRA version: 20.1Level: LLTClassification code 10019766Term: Hepatitis drug-inducedSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004483-26-DK
• Lead Sponsor: ational Center for Cancer Immune Therapy (CCIT-DK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

4.3.1Inclusion criteria
-Histologically confirmed solid cancer
-Treatment with CTLA-4 or PD-1/PD-L1 inhibitor or a combination of CTLA-4 plus PD-1 inhibitors within 6 months
-Abnormal liver parameters equal to = grade 3 ir-hepatitis defined as; AST/ALT >5 x ULN, INR = 2.5 x ULN, or bilirubin > 3.0 x ULN
-= 18 years of age
-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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

4.3.2Exclusion 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 anti-cancer drugs
-Pregnant or breastfeeding females
-Phenylketonuria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified