Pancreatic AdenocarcinomaPhase 2NCT05624918
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
A Phase 2 study testing Nab paclitaxel, Gemcitabine and NovoTTF-200T(P) in people with Pancreatic Adenocarcinoma and Resectable Pancreatic Cancer, run by Ashish Manne at 1 site in United States.
Trial summary
This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Resectable Pancreatic Cancer
- What is being tested?
- Nab paclitaxel, Gemcitabine and NovoTTF-200T(P)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 29 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- -Written informed consent and HIPAA authorization for release of personal health information.
- NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Male or non-pregnant, non-lactating female age ≥ 18 years at the time of consent.
- Karnofsky Performance Status (KPS) of ≥70% within 7 days prior to registration.
- Histological or cytological evidence of pancreatic adenocarcinoma.
- Patients must have resectable primary tumor per NCCN definitions version 2.2021 based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of PET/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis, where resectable is defined as all of the following:
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- No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery).
- No involvement, or < 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence.
- No evidence of metastatic disease. NOTE: To minimize ineligible patients, an institutional checklist, identical to the one used by the central radiologist at the end of the study, will be mandated for completion by the enrolling site investigator or radiologist. The 6-point checklist will include visible pancreatic mass; measurable disease; absence of arterial interface; venous interface of less than or equal to 180°; patent portal-splenic confluence; and absence of metastatic disease, including lymphadenopathy outside the surgical basin.
- Measurable disease according to RECIST v1.1 for solid tumors within 28 days prior to registration.
- Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer.
- Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to registration.
- Hematological
- Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3
- Hemoglobin (Hgb) ≥ 8.0 g/dL
- Platelets ≥100,000/mm3
- Renal
- ---Calculated creatinine clearance ≥ 30 cc/min using the Cockcroft-Gault formula
- Hepatic
- Bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 3 × ULN
- Alanine aminotransferase (ALT) ≤ 3 × ULN
- Females of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to registration. See the protocol for definition of childbearing potential.
- Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study, and for 6 months after the last dose of study drug(s). Males must be willing to abstain from vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study, and for 3 months after the last dose of study drug(s). See also the protocol (contraception).
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
- Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial.
Who cannot join
- Evidence of distant metastasis
- Patients with an electrical implantable device in the torso. Examples of electrical implanted medical devices include spinal cord stimulators, vagus nerve stimulators, pacemakers, and defibrillators.
- History of significant uncontrolled cardiovascular disease. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
- History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial -Known allergy to medical adhesives or conductive hydrogel (gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.
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- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.)
- No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease and treatment-free for two years.
- Patient is unwilling or unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Barbara Kleiber, MACPR, BSN, RN, 614-293-1815
Ashish Manne, MBBS
About this study
Official title: A Phase II Study of Peri-Operative NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.
- Being tested
- Nab paclitaxel, Gemcitabine, NovoTTF-200T(P)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxelDrug
Also called Abraxane
125 mg/m^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle
GemcitabineDrug
Also called Gemzar
1000 mg/m^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle
NovoTTF-200T(P)Device
Also called TTFields
Worn > 18 hr /day starting C1D1 until completion of cycle 3
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group | Experimental | Nab-paclitaxel + gemcitabine + NovoTTF-200T(P) for 3 cycles (28 day cycles)
Participants who have stable disease or better after the first 3 cycles of treatment will undergo pancreatectomy within 8 weeks of receiving treatment. If the surgery yields R0 or R1 then patient will receive another 3 cycles of treatment regimen (within 8 weeks of surgery).
Those who do not undergo surgery will still be included in the evaluable patients for the objectives Receives: Drug: Nab paclitaxel; Drug: Gemcitabine; Device: NovoTTF-200T(P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Year Overall Survival (OS)
Determine the two-year OS rate. Two-year (2-Y) OS will be calculated as the percentage of patients who remain alive at the 2 year mark from the registration date.
Measured: 2 years
Rate of Resection
Determine the rate of resection following the neoadjuvant treatment with TTFields in combination with chemotherapy. Resectability rate will be calculated as the proportion of evaluable patients undergoing R0 or R1 resection following the neoadjuvant segment of therapy.
Measured: 4 years
Secondary outcomes (10)
Assess adverse events
Assess frequency and severity of adverse events when TTFields is added to gemcitabine and nab-paclitaxel chemotherapy using CTCAE v5 criteria. Adverse Events (AE): AEs and the maximum grade for each type of adverse events will be summarized for each patient separately for the following three periods:
- During perioperative therapy
- Complications during surgery and post-operative period for 30 days
- During adjuvant therapy
Measured: 3 months, 5 months, and 10 months
Overall Response Rate (ORR)
Determine ORR. Overall response rate will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST v1.1.
Measured: 4 years
Post Resection Disease Free Survival (DFS)
Estimate the post resection DFS. DFS will be estimated in patients undergoing resection and will be defined as the date of resection to the date of first documentation of recurrence (loco-regional or distant) or death due to any cause.
Measured: 4 years
Overall Survival (OS)
Estimate the median OS is defined as the time from initiation of therapy to death from any cause. OS will be assessed from date of registration till death from any cause on an intention to treat basis.
Measured: 4 years
Rate of Major Histological Response
Assess the patterns and rate of major histological response.Pathologic response will be evaluated after the patient has had surgery, and will be based on local pathology review of the resected surgical specimen, according to the following (Treatment effect assessment will be per "College of American Pathology Protocol for the Examination of Specimens From Patients With Carcinoma of the Exocrine Pancreas")
Tumor Regression Grade:
- 0: Complete response - no residual tumor
- 1: Moderate response - minimal residual cancer (single cells or small groups of cancer cells)
- 2: Minimal response - residual cancer outgrown by fibrosis
- 3: Poor or no response - no definite response identified (minimal or no tumor kill; Extensive residual cancer)
Measured: 4 years
Patterns of Recurrence
Describe the patterns of recurrence. Pattern of recurrence will be assessed for patients undergoing resection and will be categorized into local vs distant. Loco-regional recurrence will be defined as any evidence of new disease within the pancreatic tumor bed based on surveillance scans. The pancreatic tumor bed includes:
- Superior mesenteric artery and vein lymph nodes
- Lymph nodes in porta hepatis (bile duct, portal vein, hepatic artery lymph nodes)
- Lymph nodes around left renal vein, inferior vena cava or aorta
- Celiac axis lymph nodes
Measured: 4 years
Time to Locoregional Recurrence (TLR)
Evaluate TLR. TLR is defined as the time from the date of registration to the date of locoregional recurrence after resection.
Measured: 4 years
Time to Distant Metastases (TDM)
Evaluate TDM. Time to Distant Metastases (TDM): TDM is defined as the time from the date of registration to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection.
Measured: 4 years
Chemotherapy relative dose intensity
Chemotherapy relative dose intensity delivered per agent is defined as the total cumulative dose (both perioperative and adjuvant) the patient received divided by total dose planned per protocol, times 100%.
Measured: 4 years
TTFields Compliance Rate
Evaluate compliance with TTFields. The device will be inspected either by the investigator or by a Novocure representative on a monthly basis to assess patient compliance with therapy. Average number of daily hours will be calculated.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Jul 2024
- Primary completion29 Aug 2027 (estimated)
- Study completion29 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashish Manne
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure GmbH, Ohio State University
- Responsible party
- Sponsor-investigator, Ashish Manne, Big Ten Cancer Research Consortium
- Investigators
- Ashish Manne, MD, Principal investigator, The Ohio State University Comprehensive Cancer Center- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624918
- Sponsor's protocol ID
- BTCRC GI21-500
- Status last verified
- Apr 2026
- First submitted
- 2 Nov 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Peri-Operative NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05624918
- Acronym / sponsor ID
- BTCRC GI21-500
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ashish ManneUniversity, hospital or other
- Collaborators
- NovoCure GmbH, Ohio State University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 29 Aug 2027 (estimated)
- Study completion
- 29 Aug 2028 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Group | Experimental | Drug: Nab paclitaxel, Drug: Gemcitabine, Device: NovoTTF-200T(P)Nab-paclitaxel + gemcitabine + NovoTTF-200T(P) for 3 cycles (28 day cycles) Participants who have stable disease or better after the first 3 cycles of treatment will undergo pancreatectomy within 8 weeks of receiving treatment. If the surgery yields R0 or R1 then patient will receive another 3 cycles of treatment regimen (within 8 weeks of surgery). Those who do not undergo surgery will still be included in the evaluable patients for the objectives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- -Written informed consent and HIPAA authorization for release of personal health information.
- NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Male or non-pregnant, non-lactating female age ≥ 18 years at the time of consent.
- Karnofsky Performance Status (KPS) of ≥70% within 7 days prior to registration.
- Histological or cytological evidence of pancreatic adenocarcinoma.
Key exclusion criteria (9 listed)
- Evidence of distant metastasis
- Patients with an electrical implantable device in the torso. Examples of electrical implanted medical devices include spinal cord stimulators, vagus nerve stimulators, pacemakers, and defibrillators.
- History of significant uncontrolled cardiovascular disease. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
- History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial -Known allergy to medical adhesives or conductive hydrogel (gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab paclitaxelAlso: Abraxane125 mg/m^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle | Drug | Investigational Group |
| GemcitabineAlso: Gemzar1000 mg/m^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle | Drug | Investigational Group |
| NovoTTF-200T(P)Also: TTFieldsWorn > 18 hr /day starting C1D1 until completion of cycle 3 | Device | Investigational Group |
Primary outcome
2 Year Overall Survival (OS)
Time frame: 2 years
Determine the two-year OS rate. Two-year (2-Y) OS will be calculated as the percentage of patients who remain alive at the 2 year mark from the registration date.
Rate of Resection
Time frame: 4 years
Determine the rate of resection following the neoadjuvant treatment with TTFields in combination with chemotherapy. Resectability rate will be calculated as the proportion of evaluable patients undergoing R0 or R1 resection following the neoadjuvant segment of therapy.
10 secondary outcomes
Assess adverse events
Time frame: 3 months, 5 months, and 10 months
Overall Response Rate (ORR)
Time frame: 4 years
Post Resection Disease Free Survival (DFS)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Rate of Major Histological Response
Time frame: 4 years
Patterns of Recurrence
Time frame: 4 years
Time to Locoregional Recurrence (TLR)
Time frame: 4 years
Time to Distant Metastases (TDM)
Time frame: 4 years
Chemotherapy relative dose intensity
Time frame: 4 years
TTFields Compliance Rate
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashish Manne, MD principal investigator
The Ohio State University Comprehensive Cancer Center- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab paclitaxel, Gemcitabine and NovoTTF-200T(P) in people with Pancreatic Adenocarcinoma and Resectable Pancreatic Cancer, run by Ashish Manne at 1 site in United States.
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 27 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashish Manne, MD (614-293-9863, ashish.manne@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 Year Overall Survival (OS) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.