Advanced searches left 3/3

Metastatic Pancreatic Adenocarcinoma - ClinicalTrials.gov

Summarized by Plex Scholar
Last Updated: 06 February 2022

* If you want to update the article please login/register

A Phase 1b/2 Trial of Immunotherapy With Avelumab and Pepinemab As Second Line After Folfirinox For Patients With Metastatic Pancreatic Adenocarcinoma

paraphrasedoutput:2 According to 4th% of cancer-related deaths, Pancreatic adenocarcinoma is the third leading cause of cancer-related deaths with an incidence likely to increase over the next decade. 3 Pancreatic adenocarcinoma is the third leading cause of cancer-related deaths, with an incidence that is likely to rise over the next decade. 4 In conclusion, despite modest advancements in conventional chemotherapy, five-year survival remains poor at 5-10 percent. Myeloid suppressor cells within the PDAC TME demonstrate a strong expression of Semaphorin 4D receptors, Plexin B1 and Plexin B2 molecules, as previously reported. Semaphorin 4D blockade is thus a new immunotherapeutic tactic within the PDAC TME. Phase 1b will continue until 16 evaluable patients accumulate in a dose. The MTD dose is determined as the dose yielding 30 percent or lower DLT rate after 16 patients have progressed to a specific dose based on the BOIN scheme. paraphrasedoutput:1,2 If there are 1 or less objective responses among these 16 patients during the trial's determination of futility, the trial will be stopped early for efficacy futility, according to Simon's two-stage scheme. 1,2 If after the investigation of futility, the trial will begin with early signs of efficacy. All patients will then enter the second stage of the trial at the MTD dose set by Phase 1b, and Dose escalation will conclude, and most patients will proceed into the second stage of the trial at the MTD dose determined by Phase 1b. The Phase 2 cohort will have a evaluable sample size of 40 when compared to the 16 patients from Phase 1b. The null hypothesis is that the true response rate is 0. 10 to less, and that the true response rate is 0. 23 or higher.

Source link: https://clinicaltrials.gov/ct2/show/NCT05102721


A Phase 1 Feasibility Study of Cholesterol Metabolism Disruption (Evolocumab, Atorvastatin and Ezetimibe) in Combination With FOLFIRINOX in Patients With Metastatic Pancreatic Adenocarcinoma

Both cells need cholesterol, but cancer cells need cholesterol to promote proliferation, division, and metastasis. Unwanted low cholesterol levels have been created as a result of the availability of novel cholesterol-lowering drugs that have been engineered to shield patients from heart disease-protective drugs. In newly diagnosed patients with metastatic pancreatic adenocarcinomas, this proof-of-concept study seeks to establish the suitability, acceptability, and collect preliminary results on adding a cholesterol deficit on top of FOLFIRINOX. When increasing the response to chemotherapy, it is expected that a drug-induced cholesterol deficit will slow down or stop the progression of pancreatic adenocarcinomas.

Source link: https://clinicaltrials.gov/ct2/show/NCT04862260


S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma

In patients with metastatic pancreatic adenocarcinoma, it's not possible to evaluate the safety of modified leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin in combination with PEGPH20 to determine the most suitable dose of PEGPH20 for the phase II portion of patients with metastatic pancreatic adenocarcinoma. Compared to others treated with mFOLFIRINOX + PEGPH20 alone, we can determine the overall survival of patients with metastatic pancreatic adenocarcinoma treated with mFOLFIRINOX + PEGPH20 compared to those treated with mFOLFIRINOX + PEGPH20. In this patient population, the goal is to determine progression free survival in patients acquiring mFOLFIRINOX with PEGPH20 and patients receiving mFOLFIRINOX alone. Patients with measurable disease treated with mFOLFIRINOX PEGPH20, and patients receiving mFOLFIRINOX alone in this patient population are evaluating objective tumor responses. With overall survival, progression-free survival, and response, we will investigate the relationship between maximum reduction in cancer antigen 19-9 levels and time to a maximum decline in CA 19-9 levels and time to a maximum decrease in CA 19-9 levels and time. To determine the relationship between plasma hyaluronan and tumor expression of HA with overall survival, progression-free survival, and response. Patients develop pegylated human hyaluronidase intravenously over ten minutes on day 1*, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1. 5 hours on day 2; fluorouracil IV over 46 hours on days 2-4. Arm II: Patients are provided with pegylated recombinant human hyaluronidase IV over ten minutes on day 1* and oxaliplatin, leucethydrochloride, and fluorouracil as in Arm I. *NOTE: On day 3 or 4 of courses 1 and 2, certain patients also receive pegylated recombinant human hyaluronidase.

Source link: https://clinicaltrials.gov/ct2/show/NCT01959139


A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Cancer Disease (METC) is one of the most aggressive and fatal forms of cancer with a poor prognosis. In this study, doctors will enroll patients between 18 and 75 years of age with a body mass greater than or equal to 35 kg diagnosed with Metastatic Pancreatic Cancer Disease in four separate groups, referred to as treatment arms. On day 1 and Phase 2 of every 28-day cycle, participants will receive ABBV-927 and Budigalimab as Intravenous Infusion in Phase 1b and Phase 2 and Phase 2 of every 28-day cycle, with IV Infusion in Phase 1b and Phase 2 up to a maximum of 2 years.

Source link: https://clinicaltrials.gov/ct2/show/NCT04807972

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions