Phase 2 Pancreatic Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with metastatic pancreatic ductal adenocarcinoma (a type of pancreatic cancer that has spread), confirmed through a tissue or cell sample, which must be provided during the screening period.
- People who have not previously received systemic (whole-body) treatment for their cancer after it became unresectable (unable to be removed by surgery) or metastatic. People who received chemotherapy before or after surgery with the intent to cure, or alongside radiation therapy with curative intent, may still be eligible if at least 6 months have passed since finishing that treatment before their cancer returned.
- People who have at least one measurable area of cancer that can be tracked on scans, according to standard medical measurement guidelines (confirm with trial site for details on which lesions qualify).
- People who are willing to stop taking certain medications that affect how the body processes drugs — specifically strong inhibitors or inducers of certain liver enzymes (CYP3A, CYP2C8, UGT1A1) — at least 2 weeks before starting the study treatment, and to switch to alternative medications if needed.
Who may not be able to join:
- People who have previously received systemic anticancer treatment for unresectable or metastatic disease, or any anticancer therapy within 4 weeks (or five half-lives of the drug, whichever is longer) before starting the study treatment.
- People who have previously been treated with a type of immunotherapy drug called a PD(L)-1/VEGF bispecific antibody, or related therapies, either alone or in combination.
- People who have taken high-dose steroid medicines (more than the equivalent of 10 mg per day of prednisone) within 14 days before starting the study treatment, with some exceptions for short-term or locally applied steroids.
- People who have received a live vaccine within 4 weeks before starting the study treatment.
- People who have received broad-spectrum intravenous (IV) antibiotic treatment within 2 weeks before starting the study treatment.
- People who are currently participating in, or have recently participated in, another clinical trial involving an experimental treatment, within 4 weeks or five half-lives of that drug before starting this study (whichever is longer).
- People who have taken blood-thinning antiplatelet medications — such as high-dose aspirin, clopidogrel, dipyridamole, ticlopidine, or cilostazol — within 10 days before starting the study treatment.
- People who have had major surgery, a significant injury, an open biopsy, or an invasive dental procedure (such as a dental implant) within 28 days before starting the study treatment, or who are expected to need major surgery during the trial. Placement of a vascular access device is allowed.
- People who have received an organ transplant or a bone marrow/stem cell transplant from a donor.
- People who have untreated and symptomatic cancer that has spread to the brain or spinal cord, or who require steroids or seizure medications to manage related symptoms. People with previously treated, stable, and symptom-free brain metastases may still be considered (confirm with trial site).
- People who have an active autoimmune disease (where the immune system attacks the body), or a history of one that is likely to return — such as lupus, rheumatoid arthritis, or vasculitis. People with stable autoimmune thyroid disease or type 1 diabetes may still be considered.
- People who have had another type of cancer in the past 5 years, with exceptions for certain cancers that have been fully treated locally, such as some skin cancers, early-stage bladder cancer, cervical carcinoma in situ, early breast or thyroid cancers, or early-stage prostate cancer.
- People who have had certain serious heart conditions within the 6 months before starting the study (confirm with trial site for specific conditions listed in the protocol).
- People who have uncontrolled high blood pressure or poorly controlled diabetes (confirm with trial site for specific thresholds).
- People who have had a heart attack, unstable chest pain (angina), arterial blood clot, or stroke within 6 months before starting the study.
- People who have had a deep vein blood clot, pulmonary embolism, or other significant blood clot within 3 months before joining the study, unless the condition has been fully treated and/or appropriately managed with blood-thinning medication.
- People who have serious or unhealed wounds, ulcers, or bone fractures, or who have a history (within 6 months) of or risk of certain serious complications involving the abdomen, digestive tract, or related structures, such as fistulas, perforations, abscesses, or significant bleeding.
- People who are considered by the trial doctor to be at significant risk of serious bleeding, or who have major blood clotting disorders (confirm with trial site for specific details).
- People who have uncontrolled fluid build-up around the lungs, heart, or in the abdomen that requires drainage more than once a month. People with a permanent drainage catheter in place may still be considered.
- People who experienced a serious immune-related side effect (grade 3 or higher) from a previous immunotherapy that caused them to stop that treatment. People who had a similar side effect but were able to continue treatment may be considered at the trial doctor's discretion.
- People who still have unresolved side effects from previous cancer treatments that have not improved to a mild level (grade 1 or lower), with some exceptions such as hair loss, mild nerve-related symptoms, or stable thyroid conditions managed with medication.
- People who have certain gastrointestinal (digestive system) symptoms or conditions as specified in the protocol (confirm with trial site for details).
- People with a history of serious allergic reactions to drugs, or a known allergy or intolerance to any ingredient in the study treatment.
- People who have a condition called superior vena cava syndrome (a blockage of a major vein near the heart), or symptoms of spinal cord compression.
- People who have active lung inflammation (pneumonitis) requiring steroid treatment, active interstitial lung disease, pulmonary fibrosis, or other serious lung conditions that significantly affect lung function. Some exceptions may apply for mild, asymptomatic lung changes caused by previous treatment or other factors (confirm with trial site).
- People with a known history of tuberculosis that was not successfully treated.
- People with an active syphilis infection. People with a previous syphilis infection that is now inactive may be considered, depending on specific test results (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: BioNTech Responsible Person, BioNTech SE
Phone: +49 6131 9084
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Confirmed overall response rate; Occurrence of treatment emergent adverse events (TEAEs) by severity; Occurrence of dose interruptions, reductions, and discontinuations due to TEAEs
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.