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A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT03866382

Population:

Adult

Phase:

II

This purpose of this study is to test the effectiveness of cabozantinib with nivolumab and ipilimumab in rare genitourinary cancers that have no standard treatment options. Are you Eligible? (Inclusion Criteria) Do you have confirmed diagnosis of one of the following cancers? -small cell carcinoma of the bladder; -adenocarcinoma of the bladder; -squamous cell carcinoma of the bladder; -plasmacytoid urothelial carcinoma; -any penile cancer; -sarcomatoid renal cell carcinoma; -sarcomatoid urothelial carcinoma; -renal medullary carcinoma or other miscellaneous histologic variants of the...
A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

Principal Investigator:

Amer Assal, MD

Contact Number:

212-342-5162

NCT Number:

NCT04071366

Population:

Adult

Phase:

II

Patients who will be recieving immune effector cell (IEC) therapy for the treatment of their cancer are being asked to participate in this study. IEC can produce a harmful side effect called Cytokine Release Sydnrome (CRS). CRS involves a release of a large amount of proteins into the blood stream. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or affect lung/liver/kidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and/or decreased brain function (possible...
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475(Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE667)

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03407144

Population:

Pediatrics/Adult

Phase:

II

This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults (ages 3 to 25) with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy. Immunotherapy like pembrolizumab may cause changes in the immune system that can get in the way of the tumor cells ability to grow and spread. Are you Eligible? (Inclusion Criteria) Patients must be between the ages of 3 and 25 on the day of signing informed consent Patients must have newly diagnosed, pathologically confirmed...
A MULTICENTER, OPEN-LABEL, PHASE 2 STUDY OF INTRATUMORAL CMP-001 IN COMBINATION WITH INTRAVENOUS NIVOLUMAB IN SUBJECTS WITH REFRACTORY UNRESECTABLE OR METASTATICMELANOMA

Principal Investigator:

Benjamin Izar, MD

Contact Number:

212-342-5162

NCT Number:

NCT04698187

Population:

Adult

Phase:

II

The purpose of this study is to determine the safety and efficacy of CMP-001 when given in combination with nivolumab for patients with unresectable (not capable of being surgically removed) or metastatic (cancer spreads to a different body part from where it started) melanoma. CMP-001will be given as an injection into the tumor and nivolumab will be given intravenously (into the vein). The study will collect certain lab tests in your blood and/or tumor changes while on CMP-001 plus nivolumab therapy combination so we can better understand how the drug is working. Are you Eligible? (Inclusion...
A phase II trial of atezolizumab + carboplatin + etoposide with liver-directed radiotherapy in extensive stage small cell lung cancer (ES-SCLC) patients with liver metastases

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT04923776

Population:

Adult

Phase:

II

The purpose of this study is to evaluate whether radiation treatment directed at liver metastases can be safely added to standard of care treatment for extensive stage small cell lung cancer (ES-SCLC). The current standard treatment for people who have ES-SCLC is chemotherapy, called carboplatin and etoposide, that is combined with a type of immunotherapy called atezolizumab. However, patients with liver involvement of their ES-SCLC don't respond as well to this treatment. The study aims to answer whether adding radiation directed at liver metastases can improve responses to standard...
A phase II study, with a safety lead-in, to evaluate ATX-101, a peptide drug targetingPCNA, in advanced dedifferentiated liposarcoma and leiomyosarcoma

Principal Investigator:

Matthew A. Ingham, MD

Contact Number:

212-342-5162

NCT Number:

NCT05116683

Population:

Adult

Phase:

II

The purpose of this study is to evaluate the effectiveness of a new investigational drug, ATX-101, for the treatment of dedifferentiated liposarcoma and leiomyosarcoma. ATX-101 is an intravenous (IV) drug which blocks the interaction of a protein called PCNA with a number of “stress response” proteins. These interactions are thought to be important for cancer cell survival and growth. ATX-101 may disrupt these interactions and therefore help treat the cancer. In this study, all patients will receive the same treatment. Most of the exams, tests, and procedures you will have are...
A Phase 2 Multiple Dose, Multiple-Arm, Parallel Assignment Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb®20717 Alone or in Combination with Chemotherapy or Targeted Therapies in Selected Subjects with Metastatic

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05005728

Population:

Adult

Phase:

II

the purpose of this research study is to determine the safety and tolerability of XmAb20717 by itself and in combination with other anticancer therapies (Olaparib, Cabazitaxel, Docetaxel and Carboplatin). XmAb20717 has not been studied in a significant number of humans, therefore, some of its effects are unknown. XmAb20717 is an investigational antibody drug. An antibody is a kind of protein that your body makes to help fight infections. AmAb20717 is an investigational drug in this study because it has not been approved by the U.S. Food and Drug Administration (FDA), the health authority that...
A Two-Part, Phase II, Multi-center Study of the ERK Inhibitor Ulixertinib (BVD-523) for Patients with Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

Principal Investigator:

Richard D Carvajal, MD

Contact Number:

212-342-5162

NCT Number:

NCT04488003

Population:

Adult

Phase:

II

The purpose of this study is to assess the safety and tolerability of an experimental study drug called ulixertinib (BVD-523) in the treatment of advanced cancer that shows certain genetic alterations (changes in the DNA) called ‘MEK’ or ‘atypical BRAF’ alterations and is getting worse. “Experimental” means that ulixertinib has not received authorization to be marketed for use within the USA. Ulixertinib works by inhibiting (blocking) tumor cell's 'EKR1/2' pathways, which can cause the tumor to stop growing or spreading. Are you Eligible? (Inclusion...
A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients with Advanced Systemic Mastocytosis

Contact Number:

212-342-5162

NCT Number:

NCT04996875

Population:

Adult

Phase:

II

The purpose of this study is to: • to determine the optimal dose of oral CGT9486 in patients with Advanced Systemic Mastocytosis (AdvSM). • to determine the efficacy of CGT9486 at the selected optimal dose in patients with Advanced Systemic Mastocytosis (AdvSM). Are you Eligible? (Inclusion Criteria) Age ≥18 years of age Have a form of Advanced Systemic Mastocytosis (including Aggressive Systemic Mastocytosis, Advanced Systemic Mastocytosis with an Associated Hematologic Neoplasm, or Mast Cell Leukemia). Measurable disease, per Diagnosis of Systemic Mastocytosis (SM) criteria.
ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies

Principal Investigator:

Ran Reshef, MD

Contact Number:

212-342-5162

NCT Number:

NCT04904588

Population:

Adult

Phase:

II

with a MMUD using stem cells from a donor’s blood [instead of using the donor’s bone marrow]. An allogeneic stem cell transplant is a standard treatment for blood cancers. An allogeneic transplant replaces your abnormal (or diseased) blood cells with healthy blood-making cells from a donor. We’re doing this study to see how well transplant works in adults with a MMUD using stem cells from a donor’s blood. This study treatment does not include any investigational drugs. Are you Eligible? (Inclusion Criteria) Donor: 1. Are you 18 year of age or older and younger then 36...

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