Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the...
Neuroendocrine TumorsNET3 moreA Phase 2 multi-center, open-label, single arm study of nab-sirolimus in patients with well-differentiated neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas who have not received prior treatment with mTOR inhibitors
Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
Metastatic Pancreatic CancerTerminal CancerThe purpose of this study is to evaluate the efficacy of vitamin C in improving the quality of life for metastatic pancreatic cancer patients who are resistant to chemotherapy.
Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy...
Pancreatic AdenocarcinomaStage IV Pancreatic Cancer AJCC v8This phase II trial studies whether adding pembrolizumab to olaparib (standard of care) works better than olaparib alone in treating patients with pancreatic cancer with germline BRCA1 or BRCA2 mutations that has spread to other places in the body (metastatic). BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. These proteins help repair damaged deoxyribonucleic acid (DNA) and, therefore, play a role in ensuring the stability of each cell's genetic material. When either of these genes is mutated, or altered, such that its protein product is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to some types of cancer, including pancreatic cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Olaparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of pembrolizumab to the usual treatment of olaparib may help to shrink tumors in patients with metastatic pancreatic cancer with BRCA1 or BRCA2 mutations.
Nivolumab, Ipilimumab and Chemoradiation in Pancreatic Cancer.
Borderline ResectableLocally Advanced or Metastatic Pancreatic CancerPancreatic ductal adenocarcinoma (PDAC) remains a dreadful disease due to its often advanced stage at diagnosis and poor sensitivity to chemotherapy. A locally unresectable tumor (locally advanced pancreatic cancer (LAPC)) is present in 30% of the cases and is defined as a surgically unresectable tumor encasing the adjacent arteries [celiac axis, superior mesenteric artery (SMA)]. In these patients, chemotherapy has been the standard treatment for decades, optionally combined with radiotherapy. Patients with borderline resectable pancreatic cancer (BRPC) comprise a group of patients with PDAC who are at a high risk of having positive margins if upfront resection is pursued. In addition, multiple studies have reported these patients have increased probability of early recurrence of local and systemic disease resulting in poorer outcomes. Although some patients are treated with an aggressive surgery-first approach and adjuvant systemic therapies, a preoperative chemotherapy and/or chemoradiation approach is becoming more common for all patients with BRPC, and this strategy is adapted in Danish and international guidelines. Majority of patients present with metastatic pancreatic cancer (mPC). Therapy options are limited by chemotherapy in palliative setting. The superiority of the FOLFIRINOX regimen demonstrated in the phase III mPC setting led many centers to investigate FOLFIRINOX with or without chemoradiotherapy in patients with LAPC tumor. Gemcitabine combined with nab-paclitaxel is the approved first-line treatment for patients with advanced PC. This regimen showed a median progression-free survival (PFS) of 5.5 months and a median overall survival (OS) of 8.5 months and is the predominantly used regimen in metastatic PC. The role of radiation therapy in the management of nonresectable PC remains controversial. The results of small randomized trials comparing chemoradiotherapy with chemotherapy of patients with LAPC are divergent. Immunotherapy has emerged as a therapeutic approach that offers effective and durable treatment options for subsets of patients with various types of cancer. However, these successes have not manifested similar benefits for PDAC patients mostly due to a lack of pre-existing T-cell immunity and/or a highly immunosuppressive tumor microenvironment (TME). Considering the emerging role of the TME, the combination of checkpoint blocking antibodies with agents that target the inhibitory effects of the TME could lead to better responses in tumor historically resistant to checkpoint blocking antibody approaches. For example, in heavily pretreated patients with advanced/metastatic PDAC, preliminary data from the phase 2 study CHECKPAC (NCT02866383) showed that checkpoint inhibition in combination with stereotactic body radiotherapy (SBRT) provided durable clinical benefit in a small proportion of patients, including prolonged, sustained partial responses. Furthermore, the addition of standard-of-care chemotherapy could further potentiate the anti-tumor effects of immunotherapy approaches by reducing the tumor burden, exposing antigens, and directly affecting the immunosuppressive TME compartment. To explore the safety and synergy of the proposed combinatorial approach, participants with borderline resectable, locally advanced or mPC will receive nivolumab and ipilimumab administered in combination with gemcitabine and nab-paclitaxel followed by immune-chemoradiation.
Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer
Pancreatic NeoplasmsExploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with SBRT in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (IC).
RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer
Pancreatic CancerPancreatic Cancer Non-resectable1 moreThis is a Phase I, multi center study to evaluate the safety and efficacy and determine the maximum tolerated dose (MTD) of RP72 as monotherapy and RP72 in combination with Gemcitabine in patients with pancreatic cancer. The study has two arms: Arm A: RP72 monotherapy Arm B: RP72 in combination with Gemcitabine Both treatment arms will follow a standard 3+3 design. Up to 48 adult patients with pancreatic cancer will be enrolled in this study.
OH2 Oncolytic Viral Therapy in Pancreatic Cancer
Pancreatic CancerThis phase Ib/II study evaluates the safety and efficacy of OH2 in patients with locally advanced/metastatic pancreatic cancer who have failed first-line standard treatment. OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.
Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy...
Advanced Fallopian Tube CarcinomaAdvanced Malignant Solid Neoplasm20 moreThis phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with elimusertib (BAY 1895344) in treating patients with pancreatic, ovarian, and other solid tumors that have spread to other places in the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cell from making DNA and may kill tumor cells. Elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and elimusertib in combination may shrink or stabilize cancer.
AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic...
Borderline Resectable Pancreatic CancerLocally Advanced Pancreatic AdenocarcinomaThis is a prospective, single-center, randomized, controlled phase Ⅲ study.
PANFIRE-3 Trial: Assessing Safety and Efficacy of Irreversible Electroporation (IRE) + Nivolumab...
Pancreatic CancerMetastatic Pancreatic CancerIrreversible electroporation is a local ablative technique used in the treatment of pancreatic cancer. In addition to its cytoreductive ability, IRE also induces a systemic immune response. However, this immune response is not potent enough to establish durable regression of the tumor. The immune response can be leveraged by combining IRE with immunotherapy. The primary aim of this study is to determine the safety of IRE + Nivolumab (arm B) and IRE + Nivolumab + CpG (arm C). The secondary aim is to assess efficacy of the experimental arms (B, C) and control arm A (Nivolumab monotherapy), based on overall and progression-free survival as well as locoregional and systemic immune modulation.