Is NCT07226856 recruiting in Scottsdale, AZ?

Yes, NCT07226856 is currently recruiting participants at its Scottsdale, AZ location. This metastatic pancreatic adenocarcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Scottsdale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Pancreatic Adenocarcinoma Clinical Trial in Scottsdale, AZ

Q: How do I join the metastatic pancreatic adenocarcinoma clinical trial in Scottsdale?

To join this clinical trial in Scottsdale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Metastatic Pancreatic Adenocarcinoma Study in Scottsdale

This phase II trial tests the safety, side effects and best dose of BMS-986340 in combination with nivolumab, gemcitabine, and nab-paclitaxel and how well it works in treating patients with pancreatic adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that has come back after a period of improvement (recurrent). BMS-986340 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving BMS-986340 in combination with nivolumab, gemcitabine, and nab-paclitaxel may be safe, tolerable, and/or effective in treating patients with metastatic or recurrent pancreatic adenocarcinoma.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age ≥ 18 years

Histological confirmation of pancreatic adenocarcinoma

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

Initial diagnosis of metastatic or recurrent disease (per American Joint Committee on Cancer 8th Edition \[AJCC 8th edition 2018\])

Electrocardiogram (ECG) without any clinically significant findings (QT interval corrected by Fridericia's formula (QTcF) ≤ 450 msec and no known arrhythmias) and per the investigator's assessment

Hemoglobin ≥ 9.0 g/dL (≤ 15 days prior to registration) (transfusion to achieve this level is not permitted prior to registration)

White blood cells (WBC) ≥ 2000/uL (≤ 15 days prior to registration)

Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (≤ 15 days prior to registration) (stable off any growth factor prior to registration)

Platelet count ≥ 100,000/mm\^3 (≤ 15 days prior to registration) (transfusion to achieve this level is not permitted prior to registration)

Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 15 days prior to registration) except in patients with documented Gilbert's syndrome, who must have a total bilirubin ≤ 3 x ULN

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x institution's upper limit of normal (ULN) for patients with no concurrent liver metastases, OR ≤ 5.0 x institution's ULN for patients with concurrent liver metastases (≤ 15 days prior to registration)

Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (≤ 15 days prior to registration) OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy

Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula (≤ 15 days prior to registration)

Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only

Provide written informed consent

Willingness to provide mandatory blood specimens for correlative research

Willingness to provide mandatory tissue specimens for correlative research

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria

Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:

Pregnant persons

Nursing persons

Participants of childbearing potential who are unwilling to employ adequate contraception

Failure to recover from any adverse events related to any of the following therapies received prior to registration:

Minor surgical or interventional procedure

Major surgical procedure other than diagnostic surgery, ≤ 28 days prior to registration

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection

Symptomatic congestive heart failure ≤ 6 months prior to registration

Unstable angina pectoris ≤ 6 months prior to registration

Cardiac arrhythmia

Coronary stenting or myocardial infarction ≤1 year prior to registration

Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy

Psychiatric illness/social situations that would limit compliance with study requirements

Known historical or active infection with hepatitis B, or active infection with hepatitis C (note that subjects with hepatitis C who have been clinically cured, defined as persistent absence of hepatitis C ribonucleic acid \[RNA\] detected by polymerase chain reaction \[PCR\] test in serum 12 weeks after completing antiviral treatment, are eligible for this study)

Active infection or an unexplained fever \> 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled), which in the investigator's opinion might compromise the subject's participation in the study or affect the study outcome

Interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies

Peripheral artery disease (e.g. claudication, Leo Buerger's disease)

Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma

Known human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \< 350 cells/uL. Participants with HIV are eligible if:

They have received antiretroviral therapy for ≥ 4 weeks prior to the first dose of study treatment

They continue on antiretroviral therapy as clinically indicated while enrolled on study

CD4 counts and viral load are monitored per standard of care by a local health care provider

Prior treatment of PDAC with chemotherapy in the neoadjuvant and/or adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Other active malignancy ≤ 5 years prior to registration. Participants with any of the following additional malignancies are not excluded:

Malignancies with negligible risk of metastases or death (e.g., risk of death or metastases \< 5% at 5 years) that were treated with curative intent and have not recurred within the past 2 years prior to study day 1

Completely resected basal cell or squamous cell skin cancers, carcinoma in situ (CIS) of the cervix, or ductal CIS of the breast

Malignancies considered to be indolent and never required therapy (immunotherapy, chemotherapy, radiation)

Malignancies treated with hormonal therapy alone

History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy:

Palliative radiotherapy is permitted

Placement of biliary stent/tube is permitted

Documented serum albumin \< 3 g/dL ≤ 15 days prior to registration

Known history of central nervous system (CNS) metastases

Active, known, or suspected autoimmune disease (type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement)

Systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration

Prior therapy with anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-CCR8 antibody

Malignant disease other than that being treated in this study

Receipt of an allogeneic tissue/solid organ transplant

Any other clinically significant disease or comorbidity that may adversely affect the safe delivery of treatment within this trial or may limit compliance with study requirements in the opinion of the Investigator

Known hypersensitivity to BMS-986340 or its metabolites and/or excipients and known hypersensitivity to any component of the regimens, their metabolites and/or excipients being used in the combination therapy cohorts for which the participant is being considered

Unwillingness to follow study related procedures

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Scottsdale?

Yes, this clinical trial (NCT07226856) has an active research site in Scottsdale, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Pancreatic Adenocarcinoma Treatment Options in Scottsdale, AZ

If you're searching for metastatic pancreatic adenocarcinoma treatment options in Scottsdale, AZ, this clinical trial (NCT07226856) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Scottsdale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic pancreatic adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic pancreatic adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Pancreatic Adenocarcinoma Clinical Trial in Scottsdale, AZ

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