A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

NCT05624918 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: BTCRC GI21-500
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Pancreatic Adenocarcinoma; Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 years

Secondary Outcomes (10)

• Assess adverse events

  3 months, 5 months, and 10 months

• Overall Response Rate (ORR)

  4 years

• Post Resection Disease Free Survival (DFS)

  4 years

• Overall Survival (OS)

  4 years

• Rate of Major Histological Response

  4 years

Study Arms (1)

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

Drug: Nab paclitaxel; Drug: Gemcitabine; Device: NovoTTF-200T(P)

Interventions

Gemcitabine DRUG

1000 mg/m\^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle

Also known as: Gemzar

Investigational Group

NovoTTF-200T(P) DEVICE

Worn \> 18 hr /day starting C1D1 until completion of cycle 3

Also known as: TTFields

Investigational Group

Nab paclitaxel DRUG

125 mg/m\^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle

Also known as: Abraxane

Investigational Group

Eligibility Criteria

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ashish Manne: lead
• NovoCure GmbH: collaborator
• Ohio State University: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Interventions

Taxes; Albumin-Bound Paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ashish Manne, MD

  The Ohio State University Comprehensive Cancer Center- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashish Manne, MD

CONTACT

614-293-9863; ashish.manne@osumc.edu

Ahran Lee

CONTACT

317-634-5842; alee@hoosiercancer.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 22, 2022
• Study Start: July 1, 2024
• Primary Completion (Estimated): August 29, 2027
• Study Completion (Estimated): August 29, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)