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UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System as an interventional therapy for the treatment of CTCL (Mycosis Fungoides) in patients with TMN classification stage IA, IB or IIA, an open-label,

Principal Investigator:

Larisa J Geskin, MD

Contact Number:

212-342-5162

NCT Number:

NCT05680558

Population:

Adult

Phase:

II

To assess the efficacy of the UVAR® THERAKOS® CELLEX Photopheresis System to treat early stage (IA, IB or IIA) cutaneous T-cell lymphoma (CTCL) using the modified skin-weighted assessment tool (mSWAT) to determine overall response. Are you Eligible? (Inclusion Criteria) This study will include patients who have the diagnosis of Mycosis Fungoides (including confirmatory biopsy) and are over the age of 18. Patients must have the appropriate staging (IA, IB or IIA) and be refractory to at least one of the standard therapies used to treat Mycosis Fungoides. Patients must not be on any...
A PHASE 1B/3 DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, 3-STAGE, BIOMARKER ADAPTIVE STUDY OF TAZEMETOSTAT OR PLACEBO IN COMBINATION WITH LENALIDOMIDE PLUS RITUXIMAB IN SUBJECTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA

Principal Investigator:

Jennifer Effie Amengual, MD

Contact Number:

212-342-5162

NCT Number:

NCT04224493

Population:

Adult

Phase:

I/III

The purpose of the study is to evaluate the safety and tolerability of tazemetostat in combination with lenalidomide + rituximab in patients with follicular lymphoma that has returned or has not responded to treatment (relapsed/refractory). The study will also try to select a recommended phase 3 dose of tazemetostat for further evaluation. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have follicular lymphoma? Has your disease relapsed or progressed during/after treatment? Are you able to take oral medication?
A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT02332668

Population:

Pediatrics

Phase:

I/II

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have either advanced melanoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL) or advanced, relapsed or refractory programmed cell death ligand 1 (PD-L1) positive malignant solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. This study is being sponsored by the Children's...
A PHASE 1/2 STUDY OF REGN5678 (ANTI-PSMAXCD28) WITH OR WITHOUT CEMIPLIMAB (ANTI-PD-1) IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AND OTHER TUMORS ASSOCIATED WITH PSMA EXPRESSION

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT03972657

Population:

Adult

Phase:

I/II

The purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness of REGN5678 which will be given alone first and then be given in combination with cemiplimab. Neither REGN5678 nor Cemiplimab is FDA approved to treat your type of cancer. Cemiplimab is approved by the FDA for the treatment of certain types of metastatic cutaneous squamous cell carcinoma (CSCC) (one of the main types of skin cancer ) or locally advanced CSCC (who are not candidates for curative surgery or curative radiation). REGN5678 has not yet been studied in people. Are...
A Phase 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT03947385

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety profile of IDE196 (an “investigational” drug), in enrolled subjects to find out if it is safe and possibly helpful in patients with certain cancers such as: metastatic uveal melanoma, cutaneous melanoma or colorectal cancer or cancers with mutations in genes called GNAQ, GNA11, or PRKC fusion. The study may last for approximately 25 months and your participation will depend on how well you tolerate the study drug and your overall condition during the study. Are you Eligible? (Inclusion Criteria) Do you have a solid tumor(s) that...
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 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 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04851119

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find out what dose of tegavivint should be used with children and how well it works when given to patients between the ages of 12 months to 30 years of age with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas, osteosarcomas, liver tumors (HCC and hepatoblastoma), Wilm's tumor and tumors with Wnt pathway aberrations. Tegavivint is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of children with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas,...
A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04870944

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find the highest dose of CBL0137 that can be given safely to patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory) solid tumors, including the CNS tumors and lymphoma. CBL0137 will be given into a vein on Day 1 and Day 8 of a 21 day cycle for up to 17 cycles, which will last about 24 months. Are you Eligible? (Inclusion Criteria) Inclusion Criteria: Part A: Patients must be at least 1 year of age and 21 years of age, have been diagnosed with relapsed or refractory relapsed or refractory solid tumors or lymphoma...

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