Sequential Intranodal Immunotherapy (SIIT) Combined With Anti-PD1 (Pembrolizumab) in Follicular Lymphoma

Sponsor
Oslo University Hospital
Study ID
NCT02677155
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Radiotherapy — RADIATION
    Radiotherapy 8 Gy single dose
  • Rituximab — BIOLOGICAL
    Intranodal injection 5 mg
  • Autologous dendritic cells — BIOLOGICAL
    Intranodal injection of 1 x 10 e8 cells
  • GM-CSF — BIOLOGICAL
    Subcutaneous injection of 50 ug
  • Pembrolizumab — BIOLOGICAL
    Intravenous infusion of 200 mg

Study Details

Follicular lymphoma (FL) is the most common subtype of indolent non-Hodgkin's lymphoma and is often diagnosed in advanced incurable stage. In our previous trail, Lymvac-1, patients were treated with sequential intratumoral injections of low-dose rituximab and autologous dendritic cells, combined with local radiotherapy at the same site. The aim was to overcome tumor tolerance. In this trial, clinical responses correlated strongly with systemic anti-tumor CD8+ T-cell responses detected in blood after therapy. The primary aim of the planned study (Lymvac-2) is to significantly improve rates of immunological and clinical responses by adding iv anti-PD-1 antibody (Pembrolizumab) relative to the cohort of patients previously treated with intranodal immunotherapy without Pembrolizumab (Lymvac-1). The study includes 10 patients with untreated or relapsed FL.

Key Dates

Start date
Jan 31, 2016
Status verified
Feb 2021
Primary completion
Feb 28, 2021
Completion
Feb 28, 2021

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intranodal immunotherapy and anti-PD1
    Induction phase: 3 cycles of sequential intranodal immunotherapy (SIIT), every second week: Radiotherapy 8 Gy single dose day 2, Rituximab 5 mg intranodal day 1 and 3, Autologous dendritic cells 1x 10 e8 intranodal day 4 and 5, GM-CSF 50 ug subcutaneously day 4 and 5, Pembrolizumab 200 mg intravenous day 5, Consolidation phase: Pembrolizumab 200 mg intravenous every third week for 8 cycles

Primary Outcome Measure

Overall response rate [ Time Frame: Evaluated at baseline, 2, 4, 8, 12 and 24 months ]

Related Studies