Status and phase
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This is an open-label single arm phase 2 study for patients with metastatic pancreatic ductal adenocarcinoma who have not received any prior systemic therapies.
Full description
To determine the efficacy of gemcitabine plus nab-paclitaxel in combination with PVHA and pembrolizumab as measured by progression free survival (PFS).
Hypothesis: The combination of gemcitabine, nab-paclitaxel, PVHA and pembrolizumab will improve PFS compared to the historical control for chemotherapy.
3.2 Secondary Objectives & Hypotheses
Hypothesis: The combination of gemcitabine, nab-paclitaxel, PVHA, and pembrolizumab will be safe and improve OS and ORR compared to the historical control for chemotherapy.
3.3 Exploratory Objective
Sex
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Volunteers
Inclusion criteria
A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) as defined in Appendix 3
A WOCBP who agrees to follow the contraceptive guidance in during the treatment period and for at least 120 days after the last dose of study treatment.
Exclusion criteria
Note: Participants must have recovered from all Adverse Events (AE) due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Has received any prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX40, CD137).
Has received prior radiotherapy for metastatic pancreatic ductal adenocarcinoma prior to the first dose of study treatment.
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.
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 treatment.
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.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has known history of Central Nervous System (CNS) metastases and/or carcinomatous meningitis, regardless of whether or not they have been treated.
Has severe hypersensitivity (≥Grade 3) to gemcitabine, nab-paclitaxel, PVHA or pembrolizumab and/or any of their excipients.
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.
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy.
Has a known history of Human Immunodeficiency Virus (HIV).
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV) (defined as detectable HCV RNA) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
Liver cirrhosis.
Has a known history of active TB (Bacillus Tuberculosis).
Is currently using megestrol acetate or megestrol acetate containing drugs within 10 days of registration.
Has a history of cerebrovascular accident (CVA), transient ischemic attack (TIA) or carotid artery disease requiring intervention / treatment.
Has New York Heart Association Class III or IV cardiac disease (Appendix 5) or myocardial infarction within the past 12 months.
Has known allergy to hyaluronidase.
Has clinical evidence of Deep Vein Thrombosis (DVT), PE or known thromboembolic event present during the screening period.
Active bleeding issues or a pathologic condition that is associated with high risk of bleeding.
Unable to tolerate low-molecular weight heparin 1 mg/kg as prophylaxis.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
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.
Primary purpose
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Interventional model
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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