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

NCT06390059 | Completed Phase 2

• 2 other identifiers: EF-392022-003157-55
• Study Type: interventional
• Target: 84
• Locations: 4 countries
• Sites: 15

Brief Summary

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.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

EF-39; PANOVA-4; metastatic pancreatic cancer; tumor treating fields; atezolizumab; gemcitabine and nab-paclitaxel; first line treatment; mPDAC

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR)

  Disease control rate (DCR) will be measured by the proportion of patients who had either stable disease (SD) for at least 16 weeks or confirmed partial response (PR) or complete response (CR) according to RECIST v1.1

  at least 16 weeks for SD or confirmed PR/CR

Secondary Outcomes (7)

• Overall survival (OS)

  up to 4 years

• Progression-free survival (PFS)

  up to 4 years

• 1-Year survival rate

  alive at 1 year following treatment initiation

• Objective response rate (ORR)

  up to 4 years

• Progression free survival at 6 months (PFS6)

  6 months following treatment initiation

Study Arms (1)

TTFields + atezolizumab + gemcitabine and nab-paclitaxel

EXPERIMENTAL

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

Device: Tumor Treating Fields; Drug: Atezolizumab; Drug: Gemcitabine; Drug: nab-paclitaxel

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.

Also known as: NovoTTF-200T

TTFields + atezolizumab + gemcitabine and nab-paclitaxel

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.

Also known as: Tecentriq (Brand name)

TTFields + atezolizumab + gemcitabine and nab-paclitaxel

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.

Also known as: Gemzar

TTFields + atezolizumab + gemcitabine and nab-paclitaxel

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.

Also known as: Abraxane

TTFields + atezolizumab + gemcitabine and nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form for the study protocol.
• years of age and older at the time of signing Informed Consent Form.
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
• Histologically or cytologically confirmed de-novo diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC).
• No prior treatment for PDAC.
• Life expectancy equal to or greater than 3 months.
• Measurable disease in the abdomen, as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.
• Preferably, tumor accessible for tissue collection. Consent to provide blood and tumor tissue for exploratory study is highly encouraged. Patients who cannot or are unwilling to provide tissue or blood for the exploratory study are not excluded from the study.
• If tumor tissue is available, a formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or approximately 10-15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study treatment initiation.
• If FFPE specimens described above are not available, any type of specimens (including fine-needle aspiration, cell pellet specimens \[e.g., from pleural effusion\], and lavage samples) are also acceptable. This specimen should be accompanied by the associated pathology report.
• As mentioned above, if tumor tissue is not available (e.g., depleted because of prior diagnostic testing), patients are still eligible.
• Amenable and assigned by the investigator to receive therapy with gemcitabine and nab- paclitaxel.
• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
• ANC (absolute neutrophil count) ≥ 1.5 X 109/L (1500/μL) without granulocyte colony-stimulating factor support within 14 days prior to initiation of study treatment.
• Lymphocyte count ≥ 0.5 X 109/L (500/μL).

You may not qualify if:

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
• Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
• The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
• The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
• The patient has no ongoing requirement for corticosteroids as therapy for CNS disease.
• Anticonvulsant therapy at a stable dose is permitted.
• History of leptomeningeal disease.
• Uncontrolled tumor-related pain
• Patients requiring pain medication must be on a stable regimen at study entry.
• Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to treatment initiation. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. Palliative radiotherapy is permitted, provided it does not interfere with the assessment of tumor target lesions (e.g., the lesion to be irradiated must not be the only site of measurable disease).
• Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy, if appropriate, prior to treatment initiation.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage procedure (i.e., more than one time per month).
• Patients with indwelling catheters (e.g. PleurX®) are allowed
• Uncontrolled or symptomatic hypercalcemia (ionized calcium \>1.5 mmol/L, calcium \>12 mg/dL, or corrected calcium\>ULN)
• Active or history of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome or multiple sclerosis (see Appendix 2 for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (15)

University Hospital Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

University Hospital Olomouc

Olomouc, 779 00, Czechia

Location

University Hospital Motol

Prague, 150 06, Czechia

Location

University Hospital Bulovka

Prague, 180 81, Czechia

Location

Asklepios Hospital Altona

Hamburg, 22763, Germany

Location

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

University Hospital Ulm

Ulm, 89081, Germany

Location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

University General Hospital Gregorio Maranon

Madrid, 28007, Spain

Location

University Hospital Foundation Jimenez Diaz

Madrid, 28040, Spain

Location

Clara Campal Comprehensive Cancer Center (CIOCC)

Madrid, 28050, Spain

Location

Regional University Hospital of Malaga

Málaga, 29010, Spain

Location

University Clinic of Navarra - Pamplona

Pamplona, 31008, Spain

Location

Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Location

Fribourg Cantonal Hospital, Internal Medicine and Oncology

Fribourg, 1708, Switzerland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

atezolizumab; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, single arm, multi-center, historical control pilot study.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: April 29, 2024
• Study Start: August 28, 2023
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); DE (3); CZ (4); ES (6)