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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 Three-part, Phase I/II Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM vaccine VBI-1901 with Subsequent Extension of Optimal Dose in Recurrent GBM subjects.

Principal Investigator:

Andrew B. Lassman, MD

Contact Number:

212-342-5162

NCT Number:

NCT03382977

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of a new vaccine, VBI-1901, and to know more about it's ability to boost the response of the immune system against Cytomegalovirus. The reason for testing this vaccine in people with a brain tumor is that it might one day be used to boost the ability of the immune system to fight a certain type of brain tumor. This type of treatment for brain tumors is called immunotherapy. Are you Eligible? (Inclusion Criteria) Participants must: 1. Be 18 - 70 years of age 2. Have histologically confirmed WHO grade IV glioblastoma 3. Have unequivocal evidence...
A PHASE 1/2 MULTI-CENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF KTE-X19 IN PEDIATRIC AND ADOLESCENT SUBJECTS WITH RELAPSED/REFRACTORY B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA OR RELAPSED/REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (ZUMA 4)

Principal Investigator:

Prakash Satwani, MD

Contact Number:

212-342-5162

NCT Number:

NCT02625480

Population:

Pediatrics/Adult

Phase:

I/II

Kite Pharma, Inc., a for-profit biotechnology company, is funding this research study and has designed the trial. The sponsor is testing an experimental treatment named KTE-C19, which uses the patient’s own genetically altered blood cells to treat cancer. KTE-C19 is made from blood cells that are removed from the patient. A virus (retrovirus) is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells, a type of blood cell that fights infection and eliminates cancer cells. The main purpose of this research study is to...
A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04262466

Population:

Adult

Phase:

I/II

This is a research study to determine how safe and effective a new treatment, called IMC-F106C, is for treating advanced cancers. This study is the first time the study drug is being tested in people. IMC-F106C has been developed to treat cancer by activating the body’s own immune system to fight the tumor. The study drug has 2 parts. The first part, called a “T cell receptor”, sticks very tightly to tumor cells that make markers called “HLA-A*02:01” and “PRAME”. The second part, called “anti-CD3 scFv”, sticks to a T cell (a type of white...
A Phase 1-2 dose-escalation and expansion study of ST101 in patients with advanced unresectable and metastatic solid tumors

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT04478279

Population:

Adult

Phase:

I/II

With this research study, we want to find out which dose of ST101 is tolerable and effective for people with different types of cancer. We also want to see what the body does to ST101, where ST101 goes in the body, and how long it stays in the body. This study is the first time we have given ST101 to humans. Drugs that can only be used in research are sometimes called 'investigational drugs.' Investigational means the study drug/formulation/medical device being tested is not approved by the U.S. Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Are you at least 18...
A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT04068194

Population:

Adult

Phase:

I/II

This study is being done to answer the following question: Is M3814 in combination with radiation therapy and avelumab safe and tolerable in patients with advanced or metastatic cancers. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your advanced or metastatic cancer. The usual approach is defined as care most people get for advanced or metastatic solid tumor. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have a tumor which has spread to other parts of your body or that has advanced and...
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants with Advanced Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04895709

Population:

Adult

Phase:

I/II

The main purpose of this study is to test the safety of the investigational drug, BMS-986340, administered alone and in combination with nivolumab. This study will investigate how patients with selected advanced solid tumors tolerate these drugs to identify the highest tolerable dose or the most suitable dose, explore any changes in your tumor, and your general health after receiving multiple doses of BMS-986340 alone or together with nivolumab. BMS-986340 is an immunotherapy antibody and an investigational research drug. Investigational drugs are drugs that are not yet approved by the Food...
A Phase Ib/II study of pembrolizumab, ibrutinib and rituximab in recurrent central nervous system lymphoma (CNSL)

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT04421560

Population:

Adult

Phase:

I/II

In this research study, we are looking to see how safe and effective the combination of pembrolizumab, ibrutinib and rituximab is in your type of cancer. The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab, ibrutinib or rituximab for your specific disease but these have been approved for other uses including other types of non-Hodgkin’s lymphoma. Are you Eligible? (Inclusion Criteria) You are at least 18 years old on day of signing informed consent. You have recurrent primary central nervous system lymphoma (PCNSL).
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05252416

Population:

Adult

Phase:

I/II

This first-in-human study will evaluate the recommended dose, safety, and effects (good and bad) of an experimental drug, BLU-222, either alone or in combination with therapies approved for some types of cancer, including carboplatin, ribociclib, and fulvestrant, to find out if these are safe and effective ways to treat nonresectable (unable to be removed with surgery) advanced solid tumors, including ovarian, endometrial, and estrogen receptor positive (ER+) or human epidermal growth factor receptor 2 negative (HER2-) breast cancer. All subjects participating in this research study will...
An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05451771

Population:

Adult

Phase:

I/II

The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis. Furthermore, the purpose of phase 2 part of this study is to compare the effectiveness of venetoclax and dexamethasone versus investigator’s choice treatment in this condition. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Can you comply with the procedures in this study, which include taking the study drug and extra clinic...

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