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A PHASE Ib/ll, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MUTIPLE IMMUNOTHERAPY -BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (MORPHEUS-PANCREATIC CANCER)

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03193190

Population:

Adult

Phase:

I/II

The purpose of this study is to learn which treatment works best in patients with pancreatic cancer. The study explores multiple treatment combinations. A study drug called atezolizumab may be combined with other drugs such as cobimetinib, PEGPH20, and BL-8040. Patients may also be assigned to receive standard chemotherapy treatment. We Are Now Open To Enrollment For Wave 2. Are you Eligible? (Inclusion Criteria) tients must have pancreatic ductal adenocarcinoma that continues to grow despite standard therapy. 2. Patients must be in good physical shape. This means that patients must be able...
A Phase 1 Clinical Trial of CA-4948 in Combination with Gemcitabine and Nab-Paclitaxel in Metastatic or Unresectable Pancreatic Ductal Carcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05685602

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of a drug called CA-4948 in combination with gemcitabine and nab-paclitaxel. This study tests different doses of the drug CA-4948 to see which dose is safer for people. There will be about 36 people taking part in this study. CA- 4948 is not approved by the FDA for treatment of pancreatic cancer. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have pancreatic cancer which has progressed after previous chemotherapy treatment? Are you able to make extra visits to the clinic for treatment and assessments?
Phase II, Neoadjuvant study of parasympathetic stimulation with bethanechol in combination with gemcitabine and nab-paclitaxel in borderline resectable pancreatic adenocarcinoma

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT05241249

Population:

Adult

Phase:

II

of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. Animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. The chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is FDA approved. Although bethanechol is FDA approved, in this study its use is experimental. The aim of the study is to show that...
Phase 1, window of opportunity study of parasympathetic stimulation with bethanechol in localized pancreatic adenocarcinoma prior to surgery.

Principal Investigator:

Susan E. Bates, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03572283

Population:

Adult

Phase:

I

1. Are you 18 years of age or greater? 2. Do you have recurrent glioblastoma? 3. Is this the first or second time your glioblastoma reoccurred? 4. Did your first treatment include radiotherapy and temozolomide? Are you Eligible? (Inclusion Criteria) The purpose of this study is to determine whether the drug, bethanechol, could potentially be used in combination with surgery to decrease the chance of the cancer coming back after it is removed. Bethanechol is a medication that regulates the parasympathetic nervous system and is often used to manage the side effects of chemotherapy drugs and to...
Targeted (Intra)arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with Sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC)

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT03257033

Population:

Adult

Phase:

III

The purpose of this research study is to find out whether using a newer method of targeted local delivery of the chemotherapy directly into an artery close to the pancreas tumor after treatment with standard chemotherapy that is delivered by vein is more effective at preventing the tumor from growing as compared with just receiving standard chemotherapy into a vein that goes throughout the body. This study will compare how IA and IV medication affects the time that patients survive and their quality of life. Are you Eligible? (Inclusion Criteria) Age ≥ 18 years Histologically or...
A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants with Gastrointestinal Malignancies

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04104672

Population:

Adult

Phase:

I

This study is being done to see if potential new drugs, AB680 and AB122, can be safely given in combination with chemotherapy to study patients with pancreatic cancer. The standard chemotherapy treatments that will be given in combination with AB680 and AB122 are nab-paclitaxel and gemcitabine. AB680 and AB122 are are not approved by the United States Food and Drug Administration (U.S. FDA). Are you Eligible? (Inclusion Criteria) Are you at least 18 years old? Do you have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma? Are you naïve to any prior treatment...
Phase II Open-Label, Single-Center Study Evaluating Safety and Efficacy of Pembrolizumab Following Induction with the Hypomethylating Agent Azacitidine in Patients with Advanced Pancreatic Cancer After Failure of First-Line Therapy.

Principal Investigator:

Ruth A White, MD, PHD

Contact Number:

212-342-5162

NCT Number:

NCT03264404

Population:

Adult

Phase:

II

The purpose of this study is to determine the effectiveness of combining immune therapy with a hypomethylating agent for pancreatic cancer. People who have advanced pancreatic cancer with disease progression on first-line therapy are usually treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy regimen and national guidelines recommend chemotherapy or clinical trial participation. In this study, all study subjects will receive a combination of immune therapy (every 3 weeks) and a hypomethylating agent (every 4 weeks). Are you Eligible? (Inclusion...
A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With Or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05254171

Population:

Adult

Phase:

II/III

The purpose of this study is to investigate how well SBP-101, the study drug, or a placebo works in combination with nap-paclixatel and gemcitabine to treat adenocarcinoma in study participants who have never received treatment for their cancer.A placebo is an inert substance that does not contain any study drug and has no therapeutic value. Placebos are used in studies to help the study team determine if any progress occurs due to the study treatment or due to another outside factor that is not being studied in this research. Participants will be randomized (randomly assigned by a computer)...
A Phase 2, Open-Label, Multicenter, Randomized Study Evaluating neoadjuvant therapy targeting the Adenosine immunosuppressive pathway in combination with Immune checkpoint blockade and Radiation Therapy in Patients with advanced PANCreatic Ductal

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

II

The main goal of this study is to find out if treatment with zimberelimab and stereotactic body radiation therapy alone or in combination with quemliclustat, with or without etrumadenant, given before surgery is safe and if it can further increase the immune response against the tumor. Are you Eligible? (Inclusion Criteria) You must have been diagnosed with advanced pancreatic adenocarcinoma. -You must be comfortable receiving study drug through a vein in your arm (intravenously). -You must be willing to undergo surgery.
Chemo4METPANC - A Phase 2 study with combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (BL-8040), and immune checkpoint blockade (Cemiplimab) in METastatic treatment naïve PANCreas adenocarcinoma.

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT04543071

Population:

Adult

Phase:

II

You are being invited to take part in this research study because you have been diagnosed with pancreas cancer that has spread to other parts of the body. The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing tumor size and prolonging life in patients with advanced pancreas cancer. The treatment consists of both immunotherapy (cemiplimab and motixafortide) and chemotherapy (gemcitabine and nab-paclitaxel). Gemcitabine and nab-paclitaxel are approved by the Food and Drug Administration (FDA...

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