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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...
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

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...
Precision Oncology in Advanced Pancreatic Cancer.

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT04476537

Population:

Adult

Phase:

NA

The purpose of this study is to match individual tumors with the drug or drug combinations that are most likely to destroy those tumors. The purpose of using Ruxolitinib, Imatinib, or Capecitabine to treat your pancreas cancer is to determine whether it is safe and effective in stopping pancreas cancer growth in patients who have already received one or two lines of chemotherapy. Are you Eligible? (Inclusion Criteria) Are you older than 18 years old? Do you have histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma? Do you have a life expectancy of greater...
Chemo4METPANC - A Phase 2 study with combination Chemotherapy (Gemcitabine andNab-Paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (BL-8040), and immune checkpointblockade (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...
A PHASE 1/2 FEASIBILITY, SAFETY, AND ACTIVITY STUDY OF PSCA-SPECIFIC CHIMERIC ANTIGEN RECEPTOR ENGINEERED T CELLS (BPX-601) IN SUBJECTS WITH PREVIOUSLY TREATED ADVANCED SOLID TUMORS

Principal Investigator:

Mark N. Stein, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT02744287

Population:

Adult

Phase:

I/II

The purpose of this study is to test what dose of BPX-601 can be given safely with rimiducid to patients with certain types of cancer. The study will look for side effects (good and bad) and how your body responds to the treatment. The study will also see if the treatment helps to stop your cancer from growing or spreading. BPX-601 is a treatment made from your white blood cells (T cells). Your T cells are modified in a laboratory by adding a chimeric antigen receptor gene called a CAR. The CAR recognizes a tumor marker on your cancer. The addition of the CAR is thought to help your own T...
MEKiAUTO: Phase 1/2 open-label study of combination therapy with the MEK inhibitor, cobimetinib, immune checkpoint blockade, atezolizumab, and the AUTOphagy inhibitor, hydroxychloroquine in KRAS-mutated advanced malignancies.

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04214418

Population:

Adult

Phase:

I/II

The purpose of this study is to determine how safe and effective the combination of atezolizumab, cobimetinib, and hydroxychloroquine is at treating KRAS-mutated advanced malignancies, and also to determine the maximum dose of this combination of drugs that can be tolerated by patients. This combination is thought to work by increasing the body's ability to attack tumors through its immune system. Are you Eligible? (Inclusion Criteria) You have advanced cancer, such as pancreatic, colorectal, or non-small cell lung cancer, for which no curable options are available You are 18 years of age or...
A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination with Immune Checkpoint Blockade for Patients with Advanced Solid Tumors

Principal Investigator:

Brian Henick, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03953235

Population:

Adult

Phase:

I/II

The purpose of this study is to learn more about the safety of a cancer vaccine that teaches the immune system to recognize and possibly destroy tumor cells, and to assess how well the vaccine works. The vaccine has two components. One of them is study drug GRT-C903, and the other is GRT-C904. The vaccine works by stimulating the immune system, which then fights tumors by recognizing and destroying tumor cells. This vaccine will be used in combination with FDA approved drugs ipilimumab and nivolumab, which are medications that activate the immune system. The overall study treatment, which...

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