Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NCT02754726) | Clinical Trial Compass
CompletedPhase 2
Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
United States35 participantsStarted 2016-04
Plain-language summary
The purpose of this study is to find out if the study drugs nivolumab, albumin- bound paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective when combined to treat advanced pancreatic cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years of age .
✓. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
✓. Capable of providing informed consent and complying with Trial procedures.
✓. Karnofsky Performance Status (KPS) of ≥ 70%.
✓. Life expectancy ≥ 12 weeks.
✓. Measurable tumor lesions according to RECIST 1.1 criteria.
✓. Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.
Exclusion criteria
✕. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU (5-Fluorouracil) or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
✕. Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
✕. Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
What they're measuring
1
Complete Response Rate
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 84 months
✕. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
✕. History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
✕. Laboratory values: Screening serum creatinine \> upper limit of normal (ULN); total bilirubin \> (ULN); alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≥ 2.5 ULN or ≥ 5.0×ULN if liver metastases are present; absolute neutrophil count \<1,500/mm3, platelet concentration \<100,000/mm3, hematocrit level \<27% for females or \<30% for males, or coagulation tests (prothrombin time \[PT\], partial thromboplastin time \[PTT\], International Normalized Ratio \[INR\]) \>1.5×ULN unless on therapeutic doses of warfarin.
✕. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
✕. History of HIV infection or active or chronic hepatitis B or C.