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Pembrolizumab Plus Autologous Dendritic Cell Vaccine in Patients with PD-L1 Negative Advanced Mesothelioma Who Have Failed Prior Therapies

NCT03546426 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-10-01

No results posted yet for this study

Summary

Pembrolizumab plus autologous dendritic cell vaccine in patients with PD-L1 negative advanced mesothelioma who have failed prior therapies.This is an exploratory, single-arm, open-label, phase 1b clinical trial.

Patients will receive pembrolizumab 200 mg and autologous dendritic cell vaccine every 3 weeks for the first 6 cycles, followed by pembrolizumab 200 mg every 3 weeks until confirmed progression or for a maximum of 2 years (see Figure 1 Study Schema).

After each vaccine administration patients will receive IL-2 3 MU s.c. for 5 days, from day +2 to day +6.

Conditions

  • Mesothelioma, Malignant
  • PD-L1 Negative
  • Advanced Cancer
  • Progressive Disease

Interventions

DRUG

Pembrolizumab

200 mg IV q3w until disease progression, unacceptable toxicity or informed consent withdrawal, or for a maximum of 2 years

BIOLOGICAL

Autologous dendritic cells

Autologous dendritic cells (DC) loaded with autologous tumor homogenate, 10 x7 cells ID every 3 weeks for up to six doses

DRUG

Interleukin-2

3 MU s.c. from day +2 to day +6 after each DC administration

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Massimo Guidoboni, MD · Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2027-01-31
Completion
2028-09-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT03546426 on ClinicalTrials.gov