EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma

Sponsor
NovoCure Ltd.
Study ID
NCT06390059
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Tumor Treating Fields — DEVICE
    The NovoTTF-200T is a portable, battery operated system intended for continuous home use, which delivers TTFields at a frequency of 150kHz to the patient by means of insulated transducer arrays. The NovoTTF-200T produces TTFields that exert electric forces intended to disrupt cancer cell division. TTFields at 150 kHz application will be continuous for at least 18 hours a day on average. TTFields will be continued until disease progression according to RECISTv1.1 or loss of clinical benefit.
  • Atezolizumab — DRUG
    Atezolizumab is a humanized IgG1 monoclonal antibody which targets human PD-L1and inhibits its interaction with its receptors, PD-1 and B7.1 (CD80). Both of these interactions are reported to provide inhibitory signals to T cells. Atezolizumab is administered as an intravenous solution. Atezolizumab may continue until disease progression according to RECIST v1.1 or loss of clinical benefit.
  • Gemcitabine — DRUG
    Gemcitabine is a standard of care chemotherapy drug administered as an intravenous infusion. Gemcitabine may continue until disease progression according to RECIST v1.1 or loss of clinical benefit.
  • nab-paclitaxel — DRUG
    Nab-paclitaxel is a standard of care chemotherapy drug administered as an intravenous infusion. Nab-paclitaxel may continue until disease progression according to RECIST v1.1 or loss of clinical benefit.

Study Details

The PANOVA-4 study is designed to evaluate the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel, for the treatment of metastatic pancreatic cancer. The study is intended for patients who have been diagnosed with metastatic pancreatic cancer and have not received prior systemic therapy.

Key Dates

Start date
Aug 28, 2023
Status verified
Apr 2026
Primary completion
Nov 18, 2025
Completion
Nov 18, 2025

Study Design

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

Arms

  • Experimental: TTFields + atezolizumab + gemcitabine and nab-paclitaxel
    Patients receive TTFields at 150 kHzconcomitant with atezolizumab, gemcitabine and nab-paclitaxel until disease progression or loss of clinical benefit.

Primary Outcome Measure

Disease control rate (DCR) [ Time Frame: at least 16 weeks for SD or confirmed PR/CR ]

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