Lenvatinib, Pembrolizumab, and Tumor Treating Fields (TTFields) for Second-line Treatment of Glioblastoma

Sponsor
Tel Aviv Medical Center
Study ID
NCT05973903
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Lenvatinib — DRUG
    Oral Lenvatinib 20 mg once daily
  • Pembrolizumab — DRUG
    intravenous pembrolizumab 200 mg every three weeks
  • Tumor Treating Fields (TTFields) — DEVICE
    TTF extra-dermal scalp electrodes

Study Details

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.

Key Dates

First listed
Aug 3, 2023
Start date
Jun 1, 2024
Status verified
Dec 2024
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Single-arm: participants will be treated with TTFields (200 kHz) + intravenous pembrolizumab 200 mg every three weeks and oral lenvatinib 20 mg once daily until evident progressive disease by Response Assessment in Neuro-Oncology (RANO) criteria, unacceptable toxicity, withdrawal of consent, or until completion of 35 treatment cycles (approximately 2 years) with pembrolizumab. Participants who complete treatment with pembrolizumab after 35 cycles (approximately 2 years) or CR will continue to receive lenvatinib and TTF until disease progression, development of unacceptable toxicity, or withdrawal of consent.

Primary Outcome Measure

progression free survival (PFS-6) [ Time Frame: 6 months ]

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