Actively Recruiting
Intratumoral Injection of Autologous CD1c (BDCA-1)+ MyDC, Avelumab, and Ipilimumab Plus Systemic Nivolumab
Led by Universitair Ziekenhuis Brussel · Updated on 2025-01-20
18
Participants Needed
1
Research Sites
412 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial aims at investigating the role and effect of autologous CD1c (BDCA-1)+ myeloid dendritic cells in combination with intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B compared to a combinatorial immunotherapy regimen using intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B. Concomitantly, nivolumab (a PD-1 blocking mAb) will be administered intravenously in both arms.
CONDITIONS
Official Title
Intratumoral Injection of Autologous CD1c (BDCA-1)+ MyDC, Avelumab, and Ipilimumab Plus Systemic Nivolumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before study activities
- Male or female aged 18 years or older
- Histologically confirmed advanced solid tumor not fully removable by surgery
- Have failed all standard curative and life-prolonging therapies
- Have skin or lymph node metastases suitable for intratumoral injection and biopsy
- ECOG performance status of 0 or 1
- At least one injectable metastatic lesion 10 mm or larger or multiple lesions totaling 10 mm or larger
- Adequate organ function confirmed within 14 days prior to enrollment
- Negative pregnancy test within 72 hours before enrollment for women of childbearing potential
- Availability of a tumor sample obtained within 3 months prior or new biopsy
- Adequate vascular access for leukapheresis
You will not qualify if you...
- Known active central nervous system metastases unless stable for over 4 weeks without steroids above 8 mg/day
- Active autoimmune disease requiring systemic treatment
- History of immunodeficiency or organ transplant
- Other malignancy within past 5 years except certain treated cancers with no active disease
- Prior treatment with tumor vaccine
- Chemotherapy, radiotherapy, biologic therapy, targeted therapy, or major surgery within 28 days prior to enrollment or unresolved adverse events
- Participation in another investigational study within 28 days
- Expected need for other cancer therapy during study except palliative radiation
- Symptomatic autoimmune diseases or systemic immunosuppressive therapy within specified timeframes
- Known HIV, hepatitis B or C infection
- Pregnant, breastfeeding, or unwilling to use contraception during and 3 months after treatment
- Sensitivity to study products
- Psychiatric or substance abuse conditions posing safety risk
- Immediate family member involved in this trial unless approved
- Unwillingness to use barrier contraception during and 3 months after treatment
- Prior allogeneic stem cell transplant within 5 years
- Known active tuberculosis infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UZ Brussel
Jette, Brabant, Belgium, 1090
Actively Recruiting
Research Team
B
Bart Neyns, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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