Intratumoral Injection of Autologous CD1c (BDCA-1)+ MyDC, Avelumab, and Ipilimumab Plus Systemic Nivolumab

Sponsor
Universitair Ziekenhuis Brussel
Study ID
NCT03707808
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastases to Soft Tissue
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 29, 2018
Status verified
Oct 2024
Primary completion
Dec 24, 2025
Completion
Dec 24, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate treatment
    IT injection of MyDC, ipilimumab and AS01b + IV nivolumab
  • Active Comparator: Delayed treatment
    IT injection of ipilimumab and AS01b + IV nivolumab

Primary Outcome Measure

Incidence and severity of Treatment-related Adverse Events graded according to CTCAE of intratumoral injection of autologous CD1c (BDCA-1)+ myDC plus avelumab and ipilimumab in combination with iv nivolumab [ Time Frame: 1 year ]

Central Contacts

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