NCT03546426

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study will explore treatment safety and the ability to induce PD-L1 expression of the study treatment. Secondary objective will include clinical activity and immunological efficacy. 18 Patients will be enrolled . To ensure patients' protection and avoid unacceptable toxicity, a formal safety analysis will be conducted after six patients have been observed for at least 30 days after the third treatment cycle. The study will be conducted on PD-L1 negative advanced mesothelioma patients with progressive disease after standard therapy. Previous therapies must have included an antifolate agent and a platinum compound. Study treatment: Pembrolizumab 200 mg IV q3w until disease progression, unacceptable toxicity or informed consent withdrawal, or for a maximum of 2 years Autologous dendritic cells loaded with autologous tumor homogenate, 107 cells ID q3w for up to six doses Interleukin-2 3 MU s.c. from day +2 to day +6 after each DC administration.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-12
• Primary completion: 2027-01-01
• Completion: 2028-09-01
• First posted: 2018-06-06
• Last updated: 2024-10-01

Locations

1 site across 1 country: Italy