
Pembrolizumab and Pelareorep in Treating Patients With Advanced Pancreatic Cancer
Pancreatic AdenocarcinomaStage III Pancreatic Cancer AJCC v81 moreThis phase II trial studies the side effects and how well pembrolizumab in combination with pelareorep work in treating patients with pancreatic cancer that has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. A virus, called reovirus (pelareorep), which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Giving pembrolizumab in combination with pelareorep may work better in treating patients with advanced pancreatic cancer.

Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
Mucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the RectumThis is a single-arm phase II study of twenty-one subjects with mucinous adenocarcinoma of the colon, rectum, or appendix with prior systemic therapy with a fluoropyrimidine, oxaliplatin, and irinotecan. Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks until disease progression, unacceptable toxicity, or 2 years of therapy.

FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma
Metastatic Gastro-esophageal AdenocarcinomaBackground: Gastro-esophageal (GE) cancers are a highly aggressive disease and are one of the major causes of cancer-related death worldwide. In general, combination chemotherapy has been associated with better outcomes compared with single agent chemotherapy. Fluoropyrimidine doublets FOLFOX (infusional 5FU and oxaliplatin) or FOLFIRI (infusional 5FU and irinotecan) are some of the standard first-line regimens and are less toxic than the anthracycline containing three drug regimen. Although platinum compounds are very effective in GE cancers, patients who are treated with platinum-based therapy often develop severe neuropathy and may not be able to tolerate a salvage second-line paclitaxel-based therapy. Objectives: To evaluate progression free survival, time to progression, overall survival, toxicity and quality of life in previously untreated patients with metastatic GE cancers who will be treated with a novel biweekly regimen comprised of two cycles of FOLFOX alternating with two cycles of FOLFIRI. To determine the correlation between various clinical and pathological biomarkers including an early FDG-PET scan response and patient outcomes. Design: Phase 2 clinical trial Methods: Thirty-six adult patients with histologically proven HER2 negative metastatic adenocarcinomas or poorly differentiated GE cancers will be recruited at the two major cancer centers in Saskatchewan over a period of two years. Patients will receive chemotherapy every two weeks and will undergo periodic imaging studies every 8 weeks. A Cox proportional analysis will be performed to assess various clinical and pathologic factors including an early FDG-PET/CT response and their correlation with patient outcomes. Significance: The LOGIC study aims to develop an effective but potentially less toxic regimen in the management of metastatic GE cancers, offering the possibility of longer disease control as a result of 100% exposure to two active doublets in a first-line treatment setting with lower neurotoxicities and an improved rate of salvage second-line therapy. This study will inform the care of patients with metastatic GE cancers and will be used to design a larger phase 3 trial to establish a more effective but less toxic chemotherapy regimen for patients with metastatic GE cancer and to establish role of FDG-PET/CT scan and other biomarkers in predicting outcomes.

Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal...
Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma1 moreThe purpose of this study is to determine whether CRS-207 in combination with pembrolizumab is safe and effective in adults with recurrent or metastatic gastric, gastroesophageal junction, or esophageal cancer who have received one or two prior chemotherapy regimens for advanced disease.

Regorafenib Combined With Irinotecan as Second-line in Patients With Metastatic Gastro-oesophageal...
Adenocarcinoma of the StomachAdenocarcinoma of the Gastroesophageal JunctionTrial evaluating the efficacy of regorafenib combined with irinotecan compared to irinotecan alone in second-line treatment of patients with metastatic gastro-oesophageal adenocarcinomas.

PEGPH20 Plus Gemcitabine With Radiotherapy in Patients With Localized, Unresectable Pancreatic Cancer...
Pancreatic Adenocarcinoma Non-resectableThis is a single arm phase II trial assessing the potential activity of combination PEGPH20 plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic adenocarcinoma.

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination...
Gastric AdenocarcinomaThe primary objective of this study is to characterize the safety and tolerability of andecaliximab as monotherapy and in combination with anti-cancer agents in Japanese participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal junction (GEJ) adenocarcinoma.

Recurrence After Whipple's (RAW) Study
Pancreatic CancerAmpullary Cancer13 morePancreatic head malignancies are aggressive cancers that are often inoperable when they are diagnosed. In the ~20% of patients who are diagnosed when the disease is still operable, surgery is the only treatment that can provide a chance of cure. Unfortunately, up to 75% of patients undergoing surgery will have the cancer come back (recur). One of the reasons for this is the challenge of removing the whole tumour with some surrounding non-cancerous tissue to ensure that every tumour cell has been removed. This is difficult because there are many structures very close to the pancreas (such as the blood vessels that supply the intestines) that cannot be removed. A recent review study of >1700 patients who had a Whipple's operation (the cancer operation that is performed to remove the head of pancreas) and found that whilst the majority of patients had cancer recurrence in distant sites (like the liver) that would not be affected by how the operation was performed, 12% of patients had the cancer recur just at the site of where the operation had been; this is known as 'local' recurrence. This suggests that a small amount of cancer was not removed at the time of surgery in these patients. Very few studies have looked at the relationship between the Computerised Tomography (CT) scan before surgery and the histology results (information about the tumour after it has been examined under the microscope) and whether this can predict exactly where the tumour recurs. If investigators can find factors that predict which patients get local only recurrence, investigators may be able to offer improved surgical techniques or other therapies during or immediately after the operation to these patients, hopefully leading to improved cure rates. This retrospective international study will look at these factors in patients who underwent a Whipple's operation for pancreatic cancer, bile duct cancer or ampullary cancer over a three year period between 2012 and 2015. Participating centres will provide data on pre-operative scans, complications around the time of surgery, any therapies (e.g. chemotherapy) that the patients had and if and where the cancer recurred. With this information, investigators hope to find ways to predict which patients will get local-only recurrence, so researchers can select them for future studies to see if additional treatments can improve the chance of cure from surgery for these patients.

To Determine an Effective Dose of VERU-100 for the Treatment of Advanced Prostate Cancer
Advanced Prostate AdenocarcinomaTo determine an effective dose of VERU-100 for the treatment of advanced prostate cancer by assessing its effect on testosterone levels by Day 28 and maintenance through Day 91.

Milademetan in Advanced/Metastatic Solid Tumors
Solid TumorsHead and Neck Carcinoma16 morePhase 2, multicenter, single-arm, open-label basket study designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy that exhibit wild-type (WT) TP53 and MDM2 copy number (CN) ≥ 8 using prespecified biomarker criteria.