Actively Recruiting
Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2024-07-26
27
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To determine the Maximum Tolerated Dose (MTD), and the recommended Phase 2 dose of HIA Ipilimumab in combination with IV Nivolumab by monitoring the Dose Limiting Toxicity (DLT) within 1 month after IA Ipilimumab administration in dose-escalation phase.
CONDITIONS
Official Title
Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women 18 years or older
- Able to understand and sign the informed consent form before any study procedures
- Willing and able to comply with treatment, sample collection, and study visits
- Pathological confirmation of hepatocellular carcinoma (HCC)
- Non-resectable HCC and not eligible for liver transplantation (advanced HCC, BCLC C)
- Progressed on, intolerant to, or refused standard first-line therapy and eligible for IV Nivolumab and IA Ipilimumab
- Active intrahepatic HCC with some disease untreated by local therapies
- Patients with or without active viral infections (HCV, HBV) if adequately treated
- Measurable disease per mRECIST criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks at consent
- Adequate organ function based on blood counts, liver and kidney tests, and thyroid function
- Child-Pugh class A without history of encephalopathy or significant ascites
- Women of childbearing potential must have a negative pregnancy test within 14 days before inclusion and agree to effective contraception or abstinence during study and for 5 months after last dose
- Sexually active males must agree to use condoms during study and for 7 months after last dose; partners should use effective contraception
- Eligible for pre-treatment and on-treatment tumor biopsies
- Resolved acute effects of prior therapy to baseline or grade 1 except non-safety risk adverse events
- Affiliated with a social security system or beneficiary
You will not qualify if you...
- Prior malignancy within 2 years unless treated with curative intent and no evidence of disease
- Active autoimmune disease or history of autoimmune disease except certain controlled conditions
- Medical conditions that pose risk or interfere with study participation
- Requirement for daily supplemental oxygen
- Recent (within 6 months) serious cardiovascular events
- History of encephalitis, meningitis, or uncontrolled seizures within 1 year
- Positive HIV test with AIDS; controlled HIV may be eligible
- Active infection requiring systemic therapy within 7 days before inclusion
- Other significant acute or chronic illness or psychiatric/social conditions
- Unable to undergo venous and arterial access
- Use of systemic or topical corticosteroids at immunosuppressive doses
- Recent (within 4 weeks or 5 half-lives) use or planned use of other investigational or anticancer therapies, live vaccines, allergen therapies, growth factors, major surgery, or certain bone therapies
- Previous allogeneic hematopoietic or solid organ transplant requiring immunosuppression
- History of severe allergy or hypersensitivity to study drugs or components
- Active pneumonitis or history of severe pneumonitis from immunotherapy
- Under guardianship or unable to give consent
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
L
Lambros Tselikas, MD
CONTACT
T
Thibault RAOULT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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