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Tests treatment safety and results for Hepatocellular Carcinoma (HCC)
Official title Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06911255
What this study is testing
What is Tremelimumab Plus Durvalumab (MEDI4736)?
Tremelimumab Plus Durvalumab (MEDI4736) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Also referred to as Imfinzi®, Imjudo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 1\. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form...
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1500 per mm3
- Platelet count ≥75,000 per mm3
- Albumin ≥2.8 g/dL
You likely can't join if
- 1\. Eligible for potentially curative treatment (surgical resection, radiofrequency ablation or immediate liver transplantation). 2\. Prior treatment...
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and/or tremelimumab may be included at the...
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
See the full eligibility criteria
- 1\. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally...
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1500 per mm3
- Platelet count ≥75,000 per mm3
- Albumin ≥2.8 g/dL
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the...
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤5 x institutional ULN
- Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine clearance CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24- hour urine collection for determination of creatinine...
- Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
- Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL) 11. Female patients must be either postmenopausal or, if premenopausal, must have a negative pregnancy test and agree to use 2 forms of contraception, if...
- Hormonal contraceptives such as combined oral contraceptive pill
- Intrauterine devices or the implantation of intrauterine system (IUS)
- Blockage methods (spermicides and condoms/spermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap) Blockage methods (spermicides and condoms/spermicides and vaginal diaphragm for...
- Sterilization surgery such as tubal ligation in females and vasectomy in males. 12. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be...
- Women \<50 years of age would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and...
- Women ≥50 years of age would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses...
- 1\. Eligible for potentially curative treatment (surgical resection, radiofrequency ablation or immediate liver transplantation). 2\. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- Cytotoxic...
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and/or tremelimumab may be included at the discretion of the Investigator. 11\. Any concurrent chemotherapy, IP...
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone 15. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension...
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., Computed tomography [CT] scan premedication) 20. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if...
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.