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NCT03377491

Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

Completed Phase 3 Results posted Last updated 21 January 2026
What this trial tests

Phase 3 trial testing NovoTTF-200T in Pancreas Adenocarcinoma in 571 participants. Completed in 16 October 2024.

Timeline
10 May 2018
Primary endpoint
16 October 2024
16 October 2024

Quick facts

Lead sponsorNovoCure Ltd.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment571
Start date10 May 2018
Primary completion16 October 2024
Estimated completion16 October 2024
Sites199 locations across Hong Kong, Italy, Poland, South Korea, Croatia, Belgium, Mexico, United States

Drugs / interventions tested

Conditions studied

Sponsor

NovoCure Ltd.

Who can join

18 and older, any sex, with Pancreas Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Primary · From randomization until death from any cause or last known alive.

Overall survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to overall survival of subjects treated with chemotherapy alone, measured as the period between the time of randomization and the time of death.

GroupValue95% CI
TTFields + Standard of Care16.2015.01 – 17.97
Standard of Care14.1612.81 – 15.44
Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Secondary · From randomization until radiologic disease progression per RECIST v1.1 or death, whichever occurs first.

Progression-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria. Progression is defined using the RECIST 1.1 criteria: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum

GroupValue95% CI
TTFields + Standard of Care10.619.20 – 12.19
Standard of Care9.337.59 – 11.07
Local Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Secondary · From randomization until local disease progression per RECIST v1.1 (in the absence of distant metastasis) or death, whichever occurs first.

Local progression-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the local progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria. Local progression is defined per RECIST 1.1 in the absence of distant metastasis: at least a 20% increase in the sum of diameters of target lesions, taking as reference the sma

GroupValue95% CI
TTFields + Standard of Care12.4510.68 – 14.52
Standard of Care10.419.13 – 11.79
Objective Response Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Secondary · From randomization until radiologic disease progression per RECIST v1.1 or end of tumor assessment follow-up.

Objective Response Rate (ORR) was assessed per RECIST v1.1. Complete Response (CR): disappearance of all target and non-target lesions and reduction of pathological lymph nodes to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions from baseline without new lesions or progression of non-target lesions. ORR is defined as the percentage of participants whose best overall response was CR or PR.

GroupValue95% CI
TTFields + Standard of Care88
Standard of Care73
One-year Survival Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Secondary · From randomization through 12 months after randomization.

One-year survival rate of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the 1-year survival rate of subjects treated with chemotherapy alone.

GroupValue95% CI
TTFields + Standard of Care68.162.0 – 73.5
Standard of Care60.254.2 – 65.7
Quality of Life of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Secondary · From randomization until the first ≥10-point deterioration without subsequent improvement, or death, assessed for the duration of study follow-up.

Quality of life deterioration-free survival (DFS) was assessed using the EORTC QLQ-C30 and pancreatic cancer-specific QLQ-PAN26 questionnaires. Higher scores on functional and global health status scales indicate better functioning, whereas higher symptom scores indicate worse symptoms. DFS was defined as the time from randomization to the first ≥10-point deterioration from baseline without a subsequent ≥10-point improvement, or death. DFS was evaluated separately for each QoL domain included in the analysis.

Global health status / Quality of Life
GroupValue95% CI
TTFields + Standard of Care7.15.7 – 9.4
Standard of Care5.74.1 – 7.4
Pain (EORTC QLQ-C30)
GroupValue95% CI
TTFields + Standard of Care10.18.0 – 11.6
Standard of Care7.45.9 – 9.0
Pancreatic pain (EORTC QLQ-PAN26)
GroupValue95% CI
TTFields + Standard of Care14.712.0 – 16.5
Standard of Care10.28.8 – 12.2
Digestive problems (EORTC QLQ-PAN26)
GroupValue95% CI
TTFields + Standard of Care8.36.1 – 11.2
Standard of Care5.74.4 – 7.4
Pain-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Secondary · From randomization until a ≥20-point increase from baseline in pain on the patient-reported visual analogue scale (0-100) or death, whichever occurs first.

Pain-free survival was measured as the duration between the time of randomization until a greater than or equal to twenty-point increase from baseline in a patient self-reported visual analogue scale (VAS) was recorded or death, whichever occurred first.

GroupValue95% CI
TTFields + Standard of Care15.1810.28 – 22.77
Standard of Care9.137.43 – 12.68
Puncture-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Secondary · From randomization until the first paracentesis or death, whichever occurs first.

Puncture-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to puncture-free survival of subjects treated with chemotherapy alone, measured as the duration between randomization until the first need for paracentesis or death, whichever occurs first.

GroupValue95% CI
TTFields + Standard of Care22.815.5 – NA
Standard of Care16.613.1 – NA
Resectability Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone Secondary · From randomization through the end of study follow-up. Surgical resections were captured throughout study follow-up, up to approximately 18 months.

Resectability rate defined as the number and percentage of patients whose tumors were deemed resectable and who underwent surgery.

GroupValue95% CI
TTFields + Standard of Care204.3 – 10.6
Standard of Care296.9 – 14.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TTFields + Standard of Care
Serious: 147/274 (54%)
Deaths: 199/274
Standard of Care
Serious: 131/273 (48%)
Deaths: 223/273

Serious adverse events (142 terms)

ReactionSystemTTFields + Standard of CareStandard of Care
SepsisInfections and infestations
CholangitisHepatobiliary disorders
Bile duct obstructionHepatobiliary disorders
PneumoniaInfections and infestations
AnaemiaBlood and lymphatic system disorders
PyrexiaGeneral disorders
InfectionInfections and infestations
Febrile neutropeniaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
ColitisGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
DehydrationMetabolism and nutrition disorders
Device occlusionProduct Issues
Bone marrow failureBlood and lymphatic system disorders
Cardiac failureCardiac disorders
Abdominal PainGastrointestinal disorders
Duodenal obstructionGastrointestinal disorders
Urinary tract infectionInfections and infestations
Acute kidney injuryRenal and urinary disorders
NeutropeniaBlood and lymphatic system disorders
CholecystitisHepatobiliary disorders
COVID-19Infections and infestations
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
JaundiceBlood and lymphatic system disorders
ArrhythmiaCardiac disorders
Other adverse events (65 terms — click to expand)

ReactionSystemTTFields + Standard of CareStandard of Care
NeutropeniaBlood and lymphatic system disorders
FatigueGeneral disorders
AnemiaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
DiarrheaGastrointestinal disorders
NauseaGastrointestinal disorders
Neuropathy peripheralNervous system disorders
Peripheral edemaGeneral disorders
AnorexiaMetabolism and nutrition disorders
LeukopeniaBlood and lymphatic system disorders
AlopeciaSkin and subcutaneous tissue disorders
DermatitisSkin and subcutaneous tissue disorders
Abdominal PainGastrointestinal disorders
VomitingGastrointestinal disorders
Musculoskeletal painMusculoskeletal and connective tissue disorders
Hepatic enzyme increasedInvestigations
PyrexiaGeneral disorders
RashSkin and subcutaneous tissue disorders
HypokalemiaMetabolism and nutrition disorders
ConstipationGastrointestinal disorders
PruritusSkin and subcutaneous tissue disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
HypoalbuminemiaMetabolism and nutrition disorders
PainGeneral disorders
DyspneaRespiratory, thoracic and mediastinal disorders
COVID-19Infections and infestations
Taste disorderNervous system disorders
Sleep disorderPsychiatric disorders
DizzinessNervous system disorders
ErythemaSkin and subcutaneous tissue disorders
InfectionInfections and infestations
Respiratory tract infectionInfections and infestations
CoughRespiratory, thoracic and mediastinal disorders
Urinary tract infectionInfections and infestations
HyperglycemiaMetabolism and nutrition disorders
Abdominal distensionGastrointestinal disorders
Mouth ulcerationGastrointestinal disorders
HypotensionVascular disorders
LymphopeniaBlood and lymphatic system disorders
HyponatremiaMetabolism and nutrition disorders

Most-reported serious reactions: Sepsis, Cholangitis, Bile duct obstruction, Pneumonia, Anaemia, Pyrexia, Infection, Febrile neutropenia.

Data from ClinicalTrials.gov NCT03377491 adverse events section.

Sponsor's own description

Brief Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tumour treating fields therapy for glioblastoma: current advances and future directions.
    Rominiyi O, Vanderlinden A, Clenton SJ, Bridgewater C, et al · · 2021 · cited 203× · PMID 33144698 · DOI 10.1038/s41416-020-01136-5
  2. Tumor Treating Fields in the Management of Patients with Malignant Gliomas.
    Ghiaseddin AP, Shin D, Melnick K, Tran DD. · · 2020 · cited 79× · PMID 32734509 · DOI 10.1007/s11864-020-00773-5
  3. The Mechanisms of Action of Tumor Treating Fields.
    Moser JC, Salvador E, Deniz K, Swanson K, et al · · 2022 · cited 74× · PMID 35839284 · DOI 10.1158/0008-5472.can-22-0887
  4. Advances in Pancreatic Ductal Adenocarcinoma Treatment.
    Anderson EM, Thomassian S, Gong J, Hendifar A, et al · · 2021 · cited 65× · PMID 34771675 · DOI 10.3390/cancers13215510
  5. Locally Advanced Pancreatic Cancer: Work-Up, Staging, and Local Intervention Strategies.
    van Veldhuisen E, van den Oord C, Brada LJ, Walma MS, et al · · 2019 · cited 62× · PMID 31336859 · DOI 10.3390/cancers11070976
  6. A comprehensive analysis of clinical trials in pancreatic cancer: what is coming down the pike?
    Katayama ES, Hue JJ, Bajor DL, Ocuin LM, et al · · 2020 · cited 39× · PMID 33014285 · DOI 10.18632/oncotarget.27727
  7. Tumor Treating Fields: At the Crossroads Between Physics and Biology for Cancer Treatment.
    Carrieri FA, Smack C, Siddiqui I, Kleinberg LR, et al · · 2020 · cited 29× · PMID 33215030 · DOI 10.3389/fonc.2020.575992
  8. <i>In Vivo</i> Safety of Tumor Treating Fields (TTFields) Applied to the Torso.
    Blatt R, Davidi S, Munster M, Shteingauz A, et al · · 2021 · cited 23× · PMID 34249709 · DOI 10.3389/fonc.2021.670809

Verify or expand the search:

Other trials of NovoTTF-200T

Trials testing the same drug.

Other recruiting trials for Pancreas Adenocarcinoma

Currently open trials in the same condition.

Other NovoCure Ltd. trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing