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A Phase 2, Open-Label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04830124

Population:

Adult

Phase:

II

The purpose of this study is to test the study drug ALKS 4230 to see how well the drug works on patients with advanced cutaneous melanoma or subjects with advanced muscosal melanoma and have received prior treatment with an anti- programmed death-ligand 1 (anti-PD-[L1]) therapy, and your cancer has spread. This study will explore how well the drug works on your disease and body; also explore potential biomarkers by examining your blood and tissue for genes and proteins that can help identify and/or predict whether a therapy would benefit someone or not. Are you Eligible? (Inclusion Criteria)...
A phase 2 randomized study of osimertinib versus osimertinib plus chemotherapy for patients with metastatic EGFR-mutant lung cancers that have detectable EGFR mutant cfDNA in plasma after initiation of osimertinib treatment

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04410796

Population:

Adult

Phase:

II

This study will compare the effectiveness of osimertinib alone to the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene for the epidermal growth factor receptor (EGFR). Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. This study will be adding chemotherapy to osimertinib, which could possibly add to the anticancer effects of the usual treatment and may help stop cancer from growing or spreading. Osimertinib binds to the EGFR protein and blocks its activity,...
A PHASE II OPEN-LABEL, SINGLE CENTER TRIAL OF ORAL DECITABINE-CEDAZURIDINE (INQOVI®) IN COMBINATION WITH THIOGUANINE (TABLOID®) IN PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT06351306

Population:

Adult

Phase:

II

You are being asked to participate in this study because you have acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory). The purpose of the study is to see how safe and effective the combination of decitabine- cedazuridine and thioguanine is in treating your cancer. Are you Eligible? (Inclusion Criteria) At least 18 years of age or older 2. Are you able to give written informed consent and be able to comply with all study requirements? 3. Subjects must have adequate organ function
ARST1921: A Safety, Pharmacokinetic and Efficacy Study of a γ-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375),in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04195399

Population:

Pediatrics

Phase:

II

This is a Phase 2 study of a new cancer fighting drug called Nirogacestat in children and adolescents with relapsed desmoid tumor that cannot be completely removed by surgery. All patients will receive Nirogacestat by mouth twice a day at a dose of 90 mg/m2 (maximum per dose 150 mg). The overall goals of this study are to find out what effects, good and/or bad, Nirogacestat has on children and adolescents with desmoid tumors as well as how well it works in treating desmoid tumor. In addition, we want to see how the body of a child or adolescent processes the drug. Are you Eligible? (Inclusion...
A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT05020015

Population:

Adult

Phase:

II

TAK-007 is being developed as a possible treatment for Lymphoma. TAK-007 is a cell therapy, which means that it consists of live cells that have been modified to help your body to fight Lymphoma. The use of TAK-007 in this study is experimental. Fresh (unfrozen) CAR NK cells, similar to TAK-007, are being tested in another study. In this study, frozen TAK-007 cell therapy will be used for the first time in humans. This means that at present there is less information available regarding the safety and ability to treat cancer with this medication in humans. The main purpose of this study is to...
A Phase II trial of avutometinib in combination with defactinib in metastatic diffuse gastric cancer

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

Population:

Adult

Phase:

II

There are two main types of stomach cancer based on the appearance under the microscope: intestinal-type and diffuse-type. Some stomach cancers also have a mix of intestinal-type and diffuse-type (mixed type). You are being invited to take part in this research study because you have been diagnosed with stomach cancer that has spread to other parts of the body and/or cannot be surgically removed, has diffuse-type or mixed-type cells or has gene alterations that are associated with diffuse-type stomach cancers (such as mutations in the genes CDH1 or RHOA), and you have already been treated...
A Phase 2 Study of DS-8201a (NSC#807708, IND#153036) in Adolescents, or Young Adults with Recurrent HER2+ Osteosarcoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04616560

Population:

Pediatrics/Adult

Phase:

II

The purpose of this study is to find out how well DS-8201a works in treating recurrent osteosarcoma (osteosarcoma that has come back after treatment) and what side effects is has on adolescents and young adults with HER2 positive recurrent osteosarcoma. The treatment involves giving DS-8201a through a vein (IV) once every 3 weeks. This 3 week time period is known as a cycle. You can receive up to 35 cycles (or about 24 months) of treatment as long as your tumor does not grow too much and you are not having any bad side effects. Are you Eligible? (Inclusion Criteria) Patients must have a...
Cyto-KIK TRIAL: CYTO reductive surgery in Kidney cancer plus Immunotherapy (nivolumab) and targeted Kinase inhibition (cabozantinib)

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04322955

Population:

Adult

Phase:

II

The purpose of this study is to determine if the use of immunotherapy nivolumab and the targeted therapy cabozantinib prior to removal of the kidney will increase the number subjects who are without any visible kidney cancer in their body at some point during the course of treatment. The study will also evaluate the changes that nivolumab and cabozantinib cause in the cells adjacent to the tumor in order to understand how the study medicines work and how cancer cells become resistant to these medicines. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have...
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...
Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2

Principal Investigator:

Meghna S Trivedi, MD

Contact Number:

212-342-5162

NCT Number:

NCT01042379

Population:

Adult

Phase:

II

The primary purpose of this trial is to determine whether adding new drugs to the standard initial cancer treatments for breast cancer increases the probability there there will be no residual disease (cancer cells left after many attempts to remove the cancer), compared to the initial cancer treatment alone. The intervention includes different drugs to determine which study drugs might result in better outcomes than standard treatment. Are you Eligible? (Inclusion Criteria) To be eligible for this trial patients must: have breast cancer and cannot already have had chemotherapy. be at least...

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