Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 24, 2023

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Malignant Pleural Mesothelioma
Interventions
BIOLOGICAL

Dendritic cell vaccination

WT1/DC vaccines (8-10 x 10\^6 cells in 500 μL saline solution with 5% human albumin) will be administered through intradermal injection at 5 sites (100 μL/site) in the ventromedial region of the upper arm (5-10 cm from the axillary lymph nodes). Injection sites will alternate between left and right arms. WT1/DC vaccines are administered on day 14 of each 3-weekly platinum/pemetrexed-based chemotherapy cycle. Additional WT1/DC vaccinations after the study treatment schedule can be administered (optional) at 4-weekly intervals (± 1 week).

DRUG

Atezolizumab

Atezolizumab (1200 mg) will be administered on day 0 of each 3-weekly platinum/pemetrexed-based chemotherapy cycle. Atezolizumab should be administered before chemotherapy administration as an IV infusion over 60 (±15) minutes. If the first infusion is tolerated, all subsequent infusions may bedelivered over 30 (±10) minutes. Additional atezolizumab treatment (1680 mg) after the study treatment schedule can be administered (optional) at 4-weekly intervals (± 1 week) as an IV infusion over 30-60 minutes.

DRUG

Platinum/pemetrexed based chemotherapy

On the first day of each cycle (day 0), pemetrexed 500 mg/m2 should be administered as intravenous (IV) infusion over 10 minutes, followed by cisplatin 75 mg/m2 as IV over approximately 2 hours. The actual doses of the drugs to be administered to patients will be determined by calculating the patient's body surface area at the beginning of each cycle. For ease of dose administration, the protocol allows ± 5% variance in the calculated total dose per infusion. If deemed necessary, the treating physician can decide to replace cisplatin by carboplatin. In that case, carboplatin will be delivered to an area under the concentration-time curve (AUC) of 5 as an IV infusion over 1 hour.

Trial Locations (3)

2650

RECRUITING

Antwerp University Hospital, Edegem

9000

RECRUITING

AZ Maria Middelares, Ghent

9100

RECRUITING

VITAZ, Sint-Niklaas

All Listed Sponsors
collaborator

Algemeen Ziekenhuis Maria Middelares

OTHER

collaborator

Vitaz

OTHER

collaborator

Kom Op Tegen Kanker

OTHER

collaborator

Roche Pharma AG

INDUSTRY

lead

University Hospital, Antwerp

OTHER