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Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients with Recurrent Glioblastoma

Principal Investigator:

Mary R. Welch, MD, MS

Contact Number:

212-342-5162

NCT Number:

NCT06325683

Population:

Adult

Phase:

II

The purpose of this study is to compare the usual treatment to using the study drugs, relatlimab and nivolumab in patients with recurrent brain cancer. The use of the study drugs, relatlimab and nivolumab, could shrink or stabilize your cancer. But, they could also cause side effects, which the study team will be monitoring. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drugs increase the life of patients compared to the usual...
The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer

Principal Investigator:

Yoanna S Pumpalova, MD

Contact Number:

212-342-5162

NCT Number:

NCT05610163

Population:

Adult

Phase:

II

This study is being done to answer the following question: Can we increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard chemotherapy regimens known as FOLFOX or CAPOX, given following long-course chemoradiation for patients with locally advanced rectal cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer. Are you Eligible? (...
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/2, MULTICENTER, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXd), A B7-H3 ANTIBODY-DRUG CONJUGATE (ADC), IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE, IN SUBJECTS WITH EXTENSIVE-STAGE

Principal Investigator:

Lanyi Nora Chen, MD

Contact Number:

212-342-5162

NCT Number:

NCT06362252

Population:

Adult

Phase:

I/II

The purpose of this study is to learn more about an investigational drug, which is not approved by the United States Food and Drug Administration, called ifinatamab deruxtecan (I-DXd). It is being studied to see if it is safe and if your disease, extensive- stage small cell lung cancer (ES-SCLC), or other medical condition improves while taking it alongside other drugs, Atezolizumab, Carboplatin, and Etoposide. I-DXd is a type of drug called an antibody-drug conjugate, which is made up of 2 parts: an antibody and an anticancer drug. The antibody part binds to a protein commonly found on tumor...
An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety,Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 inPatients with Relapsed or Refractory Primary Central Nervous System Lymphoma

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT03328078

Population:

Adult

Phase:

I/II

This study is being done to test the orally administered study drug, CA-4948 in combination with ibrutinib in adult patients ages 18 and over diagnosed with relapsed or refractory (RR) Primary Central Nervous System Lymphoma (PCNSL). This study will take place at multiple centers globally. The study drug is thought to work by blocking a protein in your body called interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 plays an essential role in some of the signaling pathways that are frequently not controlled in non-Hodgkin’s Lymphoma (NHL) and other hematological malignancies. When...
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 Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with

Principal Investigator:

Maria Diaz Ordonez, MD

Contact Number:

212-342-5162

NCT Number:

NCT05417594

Population:

Adult

Phase:

I/II

The main purpose of this study is to determine a dose of AZD9574 that is safe and tolerable (does not cause side effects that could prevent people from taking the drug) when given alone or in combination with temozolomide. The study will also evaluate how much of the study drug is in your blood at various times. In addition, the action of the study drug will be evaluated by measuring specific chemicals in the blood. All parts of this study are experimental which means AZD9574 is not approved by the U.S. Food and Drug Administration (FDA). This is the first time AZD9574 has been tested in...
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...

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