BridgeMD
New treatment option for Pancreatic Ductal Adenocarcinoma
Official title Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma
ClinicalTrials.gov ID: NCT06048484
What this study is testing
What is Zimberelimab?
Zimberelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Also referred to as AB122.
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
- The purpose of this study is to combine standard radiation therapy with drugs that encourages the body's immune system against cancer cells and simultaneously adding drugs which also target the pathway that the tumor uses to evade the immune system (CD73 and A2a/b). The study hopes that these drugs will work in concert with radiation therapy to kill cancer cells.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Histological or pathological confirmation of pancreatic adenocarcinoma Cytologic or histologic proof of pancreatic ductal adenocarcinoma (PDAC) needs...
- Completed 8 cycles of neoadjuvant modified FOLFIRINOX. Omission of oxaliplatin due to adverse events may be allowed in cycles 5-8 with consultation...
- Patients with surgically resectable PDAC who are considered appropriate to undergo the applicable operation.
- Eligible to undergo SBRT.
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
You likely can't join if
- Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including but not limited to anti-CTLA-4, anti-PD-1, and...
- Patients who are receiving any other investigational agents concurrently.
- Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable).
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Uncontrolled hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL, or corrected serum calcium \> ULN) or symptomatic hypercalcemia...
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis...
See the full eligibility criteria
- Histological or pathological confirmation of pancreatic adenocarcinoma Cytologic or histologic proof of pancreatic ductal adenocarcinoma (PDAC) needs to be verified by the treating institution pathologist. A...
- Completed 8 cycles of neoadjuvant modified FOLFIRINOX. Omission of oxaliplatin due to adverse events may be allowed in cycles 5-8 with consultation with the principal investigator.
- Patients with surgically resectable PDAC who are considered appropriate to undergo the applicable operation.
- Eligible to undergo SBRT.
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- No prior surgical, systemic, or radiotherapy for PDAC except for mFOLFIRINOX.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age ≥ 18 years.
- Adequate hematological and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of investigational treatment:
- Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
- Patients who are receiving any other investigational agents concurrently.
- Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable).
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Uncontrolled hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL, or corrected serum calcium \> ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on...
- History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Positive HIV test at screening or at any time prior to screening.
- Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. --Note: Patients with a past or resolved HBV infection, defined as having...
- Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV...
- Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease, and inherited liver disease.
- Known active tuberculosis.
- Inability to swallow medication or malabsorption condition that would alter the absorption of orally administered medications.
- Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents and breastfeeding should be...
- History of allergy or hypersensitivity to oxaliplatin, irinotecan, leucovorin, fluorouracil, pegfilgrastim, or any excipients.
- History of Gilbert's disease or known genotype UGT1A1 \ 28/\ 28.
- Inflammatory disease of the colon or rectum, or severe uncontrolled diarrhea.
- Active or history of celiac disease.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Lake Success, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Milwaukee, Wisconsin, 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 Lake Success, New York, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Philadelphia, Pennsylvania, United States; Milwaukee, Wisconsin, 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.