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New treatment option for Borderline Resectable Pancreatic Adenocarcinoma
Official title Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT05688215
What this study is testing
What is Fluorouracil?
Fluorouracil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for borderline resectable pancreatic adenocarcinoma.
Also referred to as 5 Fluorouracil, 5 Fluorouracilum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I/II study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female \>= 18 years of age and willing and able to provide informed consent
- Previously untreated cytologically or histologically confirmed pancreatic adenocarcinoma with one of the following:
- Borderline resectable disease. There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria...
- An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring \>= 180 degrees of the circumference of the...
- Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous...
You likely can't join if
- Recurrent or metastatic pancreatic adenocarcinoma
- Peripheral neuropathy \> grade 2
- Known status of human immunodeficiency virus (HIV) which is not well-controlled (CD4 \<300) at the time of study eligibility. Patients with...
- Untreated Hepatitis B infection: Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)...
- Participants with resolved or treated HCV (ie, HCV antibody positive but undetectable HCV ribonucleic acid [RNA]) will not be excluded from this study
- Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational products (IPs)...
See the full eligibility criteria
Who can join
- Male or female \>= 18 years of age and willing and able to provide informed consent
- Previously untreated cytologically or histologically confirmed pancreatic adenocarcinoma with one of the following:
- Borderline resectable disease. There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American...
- An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring \>= 180 degrees of the circumference of the vessel wall
- Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction
- Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction
- An interface between the tumor and SMA measuring \< 180 degrees of the circumference of the vessel wall
- Locally advanced disease. Multiple guidelines defining locally advanced PDAC have been developed, including the MD Anderson definition, the National Comprehensive Cancer Network (NCCN) definition, as well as the...
- Occlusion of the SMV-PV that is not amenable to resection and venous reconstruction
- Interface between tumor and hepatic artery that is not amenable to resection and reconstruction
- Interface between the tumor and SMA measuring \> 180 degrees of the circumference of the vessel wall
- Interface between the tumor and celiac axis measuring \> 180 degrees of the circumference of the vessel wall
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
- Platelets \>= 100 x 10\^9/L
- Hemoglobin \>= 9 g/dL
- Serum creatinine (sCr) =\ = 40 mL/min (as calculated by Modified Cockcroft-Gault formula)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (AST/[SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 X ULN
- Women with no childbearing potential because of surgery or who are at least 1 year postmenopausal (ie, 12 months post last menstrual period) or with menopause confirmed by follicle-stimulating hormone testing
- Women of childbearing potential must use an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam...
- Male participants must use an effective method of contraception (condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository, or vasectomy) throughout the...
- Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \> 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before study...
- Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before study treatment administration. Surgery requiring regional/epidural...
What rules you out
- Recurrent or metastatic pancreatic adenocarcinoma
- Peripheral neuropathy \> grade 2
- Known status of human immunodeficiency virus (HIV) which is not well-controlled (CD4 \<300) at the time of study eligibility. Patients with controlled and treated HIV/Hepatitis C virus (HCV) and an undetectable viral...
- Untreated Hepatitis B infection: Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) infection (testing is not mandatory, unless required by local...
- Participants with resolved or treated HCV (ie, HCV antibody positive but undetectable HCV ribonucleic acid [RNA]) will not be excluded from this study
- Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational products (IPs) hazardous, including but not limited to:
- Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis (lymphangitic spread of non-small cell lung cancer (NSCLC) is not disqualifying)
- Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP
- Active infection or antibiotics within 48 hours prior to study screening
- Clinically significant cardiovascular disease
- A condition or unresolved adverse event (AE) from a prior investigational drug that may obscure the interpretation of toxicity determination or AEs
- History of prior solid-organ transplantation
- Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)
- Serious medical comorbidities such as New York Heart Association Class III/IV cardiac disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12 months
- Known, existing uncontrolled coagulopathy. Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately...
- Known pregnancy, nursing women or positive pregnancy test. Requirement for women of child-bearing potential (WOCBP): Negative serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1, within 24 hours prior...
- Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the...
- History of trauma or major surgery within 28 days prior to the first dose of IP
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma...
- Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external...
- Endocrinopathies where the participant is stable on hormone replacement therapy
- History of Hashimoto syndrome within 3 years of the first of study treatment that resolved to hypothyroidism alone
- History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.