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

NCT02677155 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-03-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

Radiotherapy

Radiotherapy 8 Gy single dose

BIOLOGICAL

Rituximab

Intranodal injection 5 mg

BIOLOGICAL

Autologous dendritic cells

Intranodal injection of 1 x 10 e8 cells

BIOLOGICAL

GM-CSF

Subcutaneous injection of 50 ug

BIOLOGICAL

Pembrolizumab

Intravenous infusion of 200 mg

Sponsors & Collaborators

  • Norwegian Cancer Society

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Arne Kolstad, MD PhD · Dept of Oncology, Oslo University Hospital Radiumhospitalet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Norway

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02677155 on ClinicalTrials.gov