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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05973903
Other study ID # 0489-22 TLV
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 1, 2024
Est. completion date October 1, 2027

Study information

Verified date November 2023
Source Tel Aviv Medical Center
Contact Deborah T Blumenthal, Prof.
Phone +972-3-6947667
Email dvorab@tlvmc.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This will be a prospective, open label, single center, phase I lead-in study of 10 patients to a single arm phase-II study of 37 additional patients to assess the effectiveness of pembrolizumab and lenvatinib combination therapy for recurrent glioblastoma (rGBM) patients wearing TTFields electrodes.


Description:

Male and female patients, 18 years of age or older, with confirmed GBM progressed after first-line treatment. Patients either with or without first-line TTFields alternating field therapy - will be eligible to enroll in the study.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lenvatinib
Oral Lenvatinib 20 mg once daily
Pembrolizumab
intravenous pembrolizumab 200 mg every three weeks
Device:
Tumor Treating Fields (TTFields)
TTF extra-dermal scalp electrodes

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tel Aviv Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary progression free survival (PFS-6) Treatment with pembrolizumab and lenvatinib in rGBM patients wearing TTFields electrodes is expected to increase PFS-6 from 15 to 30%. 6 months
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