NCT04897022 - A Study of Pembrolizumab and Radiation Therapy in People With Mesothelioma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 10, 2021

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions

Malignant Pleural Mesothelioma

Interventions

DRUG

Pembrolizumab

Fixed dose of pembrolizumab 200mg IV q3 weeks

RADIATION

IMPRINT

The starting radiation dose will consist of 400cGy x5 fractions. Doses will be escalated by 100cGy per fraction (i.e. 400cGy, 500cGy, 600cGy) for a total of 3 dose levels. The MTD will be evaluated using a modified Continuous Reassessment Method. Dose limiting toxicities (DLTs) are defined as any treatment-related non-hematologic toxicity with a CTCAE v5 Grade ≥3 or grade ≥2 pneumonitis that requires use of steroids occurring after the start of IMPRINT through the first 3 months after the last fraction.

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre

11725

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited protocol activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors

lead

Memorial Sloan Kettering Cancer Center

OTHER