TerminatedPhase 1

Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma

Stopped: Study terminated due to slow recruitment and insufficient further funding.

United Kingdom5 participantsStarted 2021-02-12

Plain-language summary

This is a multi-centre non-randomised open-label phase 1 trial of pembrolizumab given in combination with SBRT to part of a pleural-based lesion in patients with unresectable MPM. This study will recruit up to 18 patients whose MPM has progressed beyond first-line of palliative chemotherapy, with a platinum-based doublet, and now requires further palliative systemic treatment, or have declined first-line palliative chemotherapy, however must have been considered suitable for a platinum doublet chemotherapy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients should be ≥18 years old on the day of signing the informed consent.
✓. Patients must have a histological or cytological diagnosis of MPM.
✓. Patients should have non-radically treatable MPM (i.e. not being considered for extrapleural pneumonectomy or pleurectomy and decortication).
✓. Patients must have measurable disease as assessed by mRECIST (i.e. at least a 1 cm rind of MPM at 2 sites on 3 different levels).
✓. Patients must have had disease progression or be intolerant of standard first-line palliative chemotherapy for MPM. Patients who have declined first-line palliative chemotherapy must have been suitable for platinum-doublet combination chemotherapy.
✓. Patient should have an ECOG performance status 0-1.
✓. Patients should be able to tolerate a course of stereotactic radiotherapy as assessed by the investigator.
✓. Patients should have pleural based disease, away from critical structures, and suitable for treatment to part of lesion with SBRT for pleural mesothelioma.

Exclusion criteria

What they're measuring

Percentage of Patients With Dose Limiting Toxicity (DLT)

Timeframe: Worst grade as assessed at cycle 1 day 1 of pembrolizumab, at each of three radiotherapy fractions (cycle 1 days 15, 17, 19) and then at day 1 of each 21 day cycle, up to 12 weeks from last dose of SBRT (i.e. cycle 6 day 1)

Trial details

NCT IDNCT04166734

SponsorRoyal Marsden NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-25

Results submitted2024-06-28

View on ClinicalTrials.gov More Advanced Malignant Pleural Mesothelioma trials