PEMBROLIZUMAB for Pancreatic cancer | Borderline resectable pancreatic cancer | Resectable pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Histologically or cytologically confirmed pancreatic cancer (WHO VI or VII)"}
• {"criterion_text":"- A female participant is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, and at least one of the following conditions applies: Nota woman of childbearing potential (WOCBP) as defined in Appendix 5 OR A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 18 weeks after the last dose of study treatment"}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- Male or female participants who are at least 18 years of age on the day of signing informed consent"}
• {"criterion_text":"- (Borderline) resectable tumor (according to DPCG criteria, see protocol table 1)"}
• {"criterion_text":"- ECOG performance status 0 or 1; Ability to undergo surgery, radiotherapy, chemotherapy and immunotherapy"}
• {"criterion_text":"- Leucocytes (WBC) ≥ 3.0 X 109/l; Platelets ≥ 100X 109 /l"}
• {"criterion_text":"- Hemoglobin ≥ 6 mmol/l"}
• {"criterion_text":"- Renal function: E-GFR > 50 ml/min"}
• {"criterion_text":"- Bilirubin < 50 µmol/l or planned for biliary drainage"}
• {"criterion_text":"- A male participant must agree to use a contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 18 weeks after the last dose of study treatment and refrain from donating sperm during this period"}

Exclusion criteria

• {"criterion_text":"- Metastatic or locally advanced (i.e. unresectable) pancreatic cancer"}
• {"criterion_text":"- A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to start of treatment / (see Appendix 5). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required"}
• {"criterion_text":"- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention."}
• {"criterion_text":"- Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)"}
• {"criterion_text":"- Has received prior systemic anti-cancer therapy including investigational agents for pancreatic cancer"}
• {"criterion_text":"- Has received prior radiotherapy within 2 weeks of start of study intervention"}
• {"criterion_text":"- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. COVID vaccines are allowed."}
• {"criterion_text":"- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug."}
• {"criterion_text":"- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded."}
• {"criterion_text":"- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients."}
• {"criterion_text":"- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed."}
• {"criterion_text":"- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection."}
• {"criterion_text":"- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis."}
• {"criterion_text":"- Has an active infection requiring systemic therapy."}
• {"criterion_text":"- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator."}
• {"criterion_text":"- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial."}
• {"criterion_text":"- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment."}
• {"criterion_text":"- Has had an allogenic tissue/solid organ transplant."}
• {"criterion_text":"- Has contra-indications for MRI (only for Amsterdam UMC and UMCU): Pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants; Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal; Patients with severe claustrophobia not able to tolerate an MRI scan."}
• {"criterion_text":"- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator"}
• {"criterion_text":"- Complete dihydropyrimidine dehydrogenase deficiency"}

Primary endpoints

• {"endpoint_text":"- Progression free survival, defined as the time from inclusion to the clinical trial to disease recurrence/progression or death from any cause","definition_or_measurement_approach":"Defined as the time from inclusion in the clinical trial to disease recurrence/progression or death from any cause"}

Secondary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Resection rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- pR0 resection rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Postoperative complications","definition_or_measurement_approach":""}
• {"endpoint_text":"- Toxicity","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life (QoL)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Completion of neoadjuvant chemotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Completion of neoadjuvant immunotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Radiological response rate","definition_or_measurement_approach":"Clinical response defined according to RECIST-criteria version 1.1"}
• {"endpoint_text":"- Serum CA 19-9 response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serum CEA response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Pathologic response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Immune responses","definition_or_measurement_approach":""}
• {"endpoint_text":"- sR0 resection rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Completion of adjuvant chemotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Completion of neoadjuvant SABR","definition_or_measurement_approach":""}
• {"endpoint_text":"- Completion of adjuvant immunotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- lymph node tumor-negative resection rate","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

09-04-2024

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

615

Number Of Sites

6

Number Of Participants

66

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands