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Metastatic Pancreatic Ductal AdenocarcinomaPhase 2NCT06390059

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

A Phase 2 study testing Tumor Treating Fields, Atezolizumab and Gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by NovoCure Ltd. at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tumor Treating Fields, Atezolizumab and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
15 sitesin 4 countries
Study dates
21 Aug 2023to 18 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form for the study protocol.
  • 18 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.
Show all 42Show fewer
  • 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).
  • WBC (white blood cell) count ≥2.5x109/L (2500/ μL).
  • Platelet count ≥ 100 X 109/L (100,000/μL) without transfusion.
  • Hemoglobin ≥ 90 g/L (9 g/dL). Patients may be transfused to meet this criterion.
  • AST (aspartate aminotransferase), ALT (alanine aminotransferase), and ALP (alkaline phosphatase) ≤ 2.5 X upper limit of normal (ULN), with the following exceptions:
  • Patients with documented liver metastases: AST and/or ALT ≤ 5 X ULN. Patients with documented liver or bone metastases: ALP ≤ 5 X ULN.
  • Total bilirubin ≤ 1.5 X ULN with the following exception:
  • Patients with known Gilbert disease: total bilirubin ≤ 3 X ULN.
  • Creatinine ≤ 1.5 X ULN.
  • Albumin ≥ 25 g/L (2.5 g/dL).
  • For patients not receiving therapeutic anticoagulation: INR/PT (international normalized ratio/ prothrombin time) or aPTT/PTT (activated partial thromboplastin time/partial thromboplastin time) ≤ 1.5 X ULN.
  • For patients receiving therapeutic anticoagulation: stable anticoagulation regimen.
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following:
  • Negative total hepatitis B core antibody (HBcAb)
  • Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA (deoxyribonucleic acid) test. The HBV DNA test must be performed for patients who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA (Ribonucleic acid) test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs, as defined below:
  • Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period, for 5 months after the final dose of atezolizumab, for 6 months after the final dose of gemcitabine and for 6 months after the final dose of nab-paclitaxel. Women must refrain from donating eggs during this same period.
  • A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause),and is not permanently infertile due to surgery (i.e. removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
  • Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
  • All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before initiation of study treatment.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm, as defined below:
  • With a female partner of childbearing potential who is not pregnant, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for 6 months after the final dose of gemcitabine and for 6 months after the final dose of nab-paclitaxel. Men must refrain from donating sperm during this same period.
  • With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of gemcitabine and for 6 months after the final dose of nab-paclitaxel to avoid exposing the embryo.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
  • Able to operate the NovoTTF-200T device independently or with the help of a caregiver.

Who cannot join

  • 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.
Show all 49Show fewer
  • 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:
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible for this study
  • Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible for this study
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g. patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
  • Rash must cover <10% of body surface area
  • Disease is well controlled at baseline and only requiring low-potency topical steroids
  • No acute exacerbations of underlying condition within the last 12 months requiring treatment with either psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral steroids
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Positive human immunodeficiency (HIV) test at screening or at any time prior to screening.
  • Current treatment with anti-viral therapy for HBV (hepatitis B virus).
  • Active tuberculosis.
  • Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety.
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab.
  • Prior allogeneic stem cell or solid organ transplantation.
  • History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS (overall survival) rate > 90%) treated with an expected curative outcome, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  • Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study. For patients undergoing laparoscopy (without resection) for PDAC, within 14 days prior to initiation of study treatment.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or device, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
  • History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent.
  • Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel.
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4 (cytotoxic T lymphocyte antigen-4), anti PD-1 (programmed cell death protein 1), and anti PD-L1 (programmed death-ligand 1) therapeutic antibodies.
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin 2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment.
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti - tumor necrosis factor-α [TNF-α] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
  • Patients who received acute, low-dose, systemic immunosuppressant medications or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast-agent allergy) are eligible for the study. It is recommended that patients requiring use of steroids for a contrast-agent allergy will undergo chest CT without contrast-agent and abdomen and pelvis MRI (Magnetic Resonance Imaging) with Gadolinium.
  • Patients who received mineralocorticoids (e.g., fludrocortisone), inhaled or low-dose corticosteroids for COPD (chronic obstructive pulmonary disease) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to initiation of study treatment.
  • Implantable electronic medical devices in the torso, such as pacemakers.
  • Known allergies to medical adhesives or hydrogel, or to one of the chemotherapies used in this study or biopharmaceuticals produced in Chinese hamster ovary cell products or to any component of the atezolizumab formulation.
  • Treatment with therapeutic oral or IV (intravenous) antibiotics within 2 weeks prior to initiation of study treatment.
  • Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • Pregnant or breast-feeding, or intending to become pregnant during study treatment or within 5 months after the final dose of atezolizumab or within 6 months after the last dose of gemcitabine or within 6 months after the last dose of nab-paclitaxel, whichever is later.
  • Unable to follow the protocol for medical, psychological, familial, geographic or other reasons.
  • Admitted to an institution by administrative or court order.

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

Spain6 sites

  • University Hospital Vall d'Hebron

    Barcelona, 08035

  • University General Hospital Gregorio Maranon

    Madrid, 28007

  • University Hospital Foundation Jimenez Diaz

    Madrid, 28040

  • Clara Campal Comprehensive Cancer Center (CIOCC)

    Madrid, 28050

  • Regional University Hospital of Malaga

    Málaga, 29010

  • University Clinic of Navarra - Pamplona

    Pamplona, 31008

Other trials in Spain

Czechia4 sites

  • University Hospital Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital Olomouc

    Olomouc, 779 00

  • University Hospital Motol

    Prague, 150 06

  • University Hospital Bulovka

    Prague, 180 81

Other trials in Czechia

Germany3 sites

  • Asklepios Hospital Altona

    Hamburg, 22763

  • University Hospital Tuebingen

    Tübingen, 72076

  • University Hospital Ulm

    Ulm, 89081

Other trials in Germany

Switzerland2 sites

  • Inselspital, University Hospital Bern

    Bern, 3010

  • Fribourg Cantonal Hospital, Internal Medicine and Oncology

    Fribourg, 1708

Other trials in Switzerland

About this study

Official title: PANOVA-4: Pilot, Single Arm Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

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.

Read the detailed description

The PANOVA-4 study is an international, multi-center, research study for female and male adult patients diagnosed with metastatic pancreatic ductal adenocarcinoma (mPDAC).

The purpose of the study is to test the efficacy and safety of TTFields, delivered using the NovoTTF-200T Treatment Kit, concomitantly with atezolizumab, gemcitabine and nab-paclitaxel as first line treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC).

The chemotherapy used in this study, gemcitabine and nab-paclitaxel, are standard-of-care treatment for metastatic pancreatic cancer. The atezolizumab drug and the NovoTTF-200T device are investigational for this tumor type. Atezolizumab is an immunotherapy drug that works with the immune system to help fight cancer. NovoTTF-200T is a non-invasive medical device that delivers Tumor Treating Fields (TTFields) at 150kHz to the cancer in the abdominal region, where the tumor is located.

The study is expected to enroll 76 patients in centers around the world. The expected duration on study per patient is approximately 12 months.

Patients with previously untreated mPDAC who meet all inclusion criteria and none of the exclusion criteria as determined by the investigator will initiate study treatment within 28 days from signing the Informed Consent Form (ICF) to receive TTFields (150 kHz), atezolizumab, gemcitabine and nab-paclitaxel.

All patients enrolled in the study will receive continuous TTFields therapy concomitant with monthly atezolizumab treatments for their metastatic pancreatic cancer and weekly gemcitabine and nab-paclitaxel.

While on the study, patients will be asked to visit the clinic every 4 weeks, in order to perform a physical examination, blood tests,and some other assessments. Patients will be asked to have a radiological examination (CT scan of the chest abdomen and pelvis) every 8 weeks to assess the status of the disease.

Study treatments will continue until disease progression according to RECIST v1.1, or loss of clinical benefit.

Patients who experience disease progression will be permitted to continue study treatments if there is evidence of clinical benefit.

Subjects will return to the clinic for one final visit approximately 30 days after discontinuation of the last study treatment.

Following the final visit, the subjects will be contacted every three months by telephone to answer basic questions about their health status.

Being tested
Tumor Treating Fields, Atezolizumab, Gemcitabine, nab-paclitaxel
Keywords
EF-39, PANOVA-4, metastatic pancreatic cancer, tumor treating fields, atezolizumab, gemcitabine and nab-paclitaxel, first line treatment, mPDAC
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor Treating FieldsDevice

    Also called NovoTTF-200T

    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.

  • AtezolizumabDrug

    Also called Tecentriq (Brand name)

    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.

  • GemcitabineDrug

    Also called Gemzar

    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-paclitaxelDrug

    Also called Abraxane

    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 groups in NCT06390059
Study groupRoleWhat they receive
TTFields + atezolizumab + gemcitabine and nab-paclitaxelExperimentalPatients receive TTFields at 150 kHzconcomitant with atezolizumab, gemcitabine and nab-paclitaxel until disease progression or loss of clinical benefit.
Receives: Device: Tumor Treating Fields; Drug: Atezolizumab; Drug: Gemcitabine; Drug: nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at least 16 weeks for SD or confirmed PR/CR

Secondary outcomes (7)

  1. Overall survival (OS)

    Overall survival (OS) will be measured from time of treatment initiation until date of death.

    Measured: up to 4 years

  2. Progression-free survival (PFS)

    Progression-free survival (PFS) will be measured as the time from treatment initiation until progression per RECIST v1.1 or death.

    Measured: up to 4 years

  3. 1-Year survival rate

    1 year survival rate will be measured as the percentage of patients who are alive at one year following treatment initiation .

    Measured: alive at 1 year following treatment initiation

  4. Objective response rate (ORR)

    Objective response rate (ORR) will be measured by the proportion of patients who had either complete response or partial response per RECIST v1.1 following treatment initiation.

    Measured: up to 4 years

  5. Progression free survival at 6 months (PFS6)

    Progression free survival at 6 months (PFS6) will be measured as the proportion of patients who are not progressive per RECIST v1.1 at 6 months following treatment initiation.

    Measured: 6 months following treatment initiation

  6. Duration of response (DOR)

    Duration of response (DOR) will be defined as the time from the first occurrence of a documented objective response (complete or partial response) to disease progression or death from any cause (whichever occurs first) as determined by the investigator according to RECIST v1.1.

    Measured: up to 4 years

  7. Rate of of patients with treatment emergent adverse events

    Adverse Events will be reported as incidence by body system and MedDRA term out of the number of patients who receive at least 1 day of TTFieldstreatment or one dose of atezolizumab. Based on Common Terminology Criteria for Adverse Events, CTCAE v5.0.

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start21 Aug 2023
  3. Primary completion18 Nov 2025
  4. Study completion18 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, open-label, single arm, multi-center, historical control pilot study.
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06390059
Sponsor's protocol ID
EF-39
Other IDs
EF-39, 2022-003157-55
Status last verified
Apr 2026
First submitted
29 Feb 2024
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tumor Treating Fields, Atezolizumab and Gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by NovoCure Ltd. at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain, Czechia, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (DCR) (time frame: at least 16 weeks for SD or confirmed PR/CR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06390059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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