Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT04166734
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Malignant Pleural Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab will be continued dosed at 200 mg given every 3 weeks Drug: Pembrolizumab Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.
  • Stereotactic Body Radiotherapy (SBRT) — RADIATION
    Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)

Study Details

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.

Key Dates

Start date
Feb 12, 2021
Status verified
Feb 2026
Primary completion
Jul 25, 2023
Completion
Jul 25, 2023

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Initial safety cohort
    Patients will receive an initial dose of pembrolizumab in week 1 dosed at 200 mg. They will then receive SBRT dosed at 30 Gy in 3 fractions (#) alternate days in week 3. Treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.
  • Other: Expansion cohort
    An additional 12 patients will be recruited for this cohort. Patients will receive an initial dose of pembrolizumab at 200 mg in week 1. This will be followed in by SBRT dosed at 30 Gy in 3 fractions (#) alternate days in week 3. Treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.

Primary Outcome Measure

Percentage of Patients With Dose Limiting Toxicity (DLT) [ Time Frame: 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) ]

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