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A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A NeoantigenVaccine, in Combination with Immune Checkpoint Blockade for Patients with Metastatic ColorectalCancer

Principal Investigator:

Yoanna S Pumpalova, MD

Contact Number:

212-342-5162

NCT Number:

NCT05141721

Population:

Adult

Phase:

II/III

The purpose of this research study is to learn more about an experimental personalized vaccine that has two components called GRT-C901 and GRT-R902. GRT-C901 works by increasing your immune system’s response to decrease levels of neoantigens (proteins that help your tumor grow) in your body. GRT-R902 works by using proteins in your body called messenger ribonucleic acid (mRNA) to decrease the levels of neoantigens. Study participants will be randomized, like flipping a coin, into two groups--treatment group and control group. We will learn more about the effects of this vaccine on...
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02205762

Population:

Pediatrics

Phase:

II/III

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age < 18 years). LCH is a rare disease of the immune system that may affect any age group. It can affect many different organs, including the skeleton, skin, lymph nodes, liver, lungs, spleen, hematopoiesis, or central nervous system (CNS). There are two widely recognized disease extent categories: single-system LCH (involvement of a single organ or system) and multisystem LCH (involvement of 2 or more organ systems). Patients with SS-LCH of the skeleton, skin, or the...
RINGSIDE: A Phase 2/3, Randomized, Multicenter Study toEvaluate AL102 in Patients with Progressing Desmoid Tumors

Principal Investigator:

Prabhjot Singh Mundi, MD

Contact Number:

212-342-5162

NCT Number:

NCT04871282

Population:

Adult

Phase:

II/III

You are being asked to participate in this study because you have been diagnosed with a progressive desmoid tumor. The purpose of this study is to see if the study drug, called AL102 (referred to from now on as the “study drug”), is safe and effective in people with progressive desmoid tumors. The study will also look at how your body responds to the study drug and how your body processes the drug . The study drug works by stopping a chemical pathway in the cells that allows desmoid tumors to grow. It is hoped that by stopping this pathway the study drug will stop desmoid tumor...
10005- A Phase 2 Study of Anti-PD-L1 Antibody MPDL3280A (Atezolizumab) in Alveolar Soft Part Sarcoma

Principal Investigator:

Prabhjot Singh Mundi, MD

Contact Number:

212-342-5162

NCT Number:

NCT03141684

Population:

Adult

Phase:

II
A PHASE 2, MULTI-COHORT, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF bb2121 IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA AND IN SUBJECTS WITH CLINICAL HIGH-RISK MULTIPLE MYELOMA (KarMMa-2)

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT03601078

Population:

Adult

Phase:

II

The purpose of this study is to determine if the investigational therapy called bb2121 is effective in treating multiple myeloma. bb2121 is a type of therapy known as chimeric antigen receptor (CAR) T cell therapy. T cells are a kind of white blood cell which form part of your body’s immune system. Your T cells will be separated from the rest of the immune cells and then modified to make the bb2121 T cells. The bb2121 T cells manufactured for you will be shipped to the study site when you are ready for the treatment and infused back into your blood. Are you Eligible? (Inclusion Criteria...
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...
ANBL1821: A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03794349

Population:

Pediatrics

Phase:

II

The goal of this study is to utilize eflornithine (DFMO) to improve response rates in patients with relapsed neuroblastoma in combination with dinutuximab/irinotecan/temozolomide compared to patients assigned to receive dinutuximab/irinotecan/temozolomide alone. DFMO works to inhibit ODC1, an enzyme in the tumor growth pathway. Are you Eligible? (Inclusion Criteria) Patients must be diagnosed with active relapsed, refractory or progressive disease. Patients must have histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow...
ACNS1723: A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03919071

Population:

Pediatrics

Phase:

II

The purpose of this study is to see if using two drugs called dabrafenib and trametinib after radiation treatment will be better than treatments used in the past in improving survival for patients with newly-diagnosed high grade glioma (HGG) that have the BRAF V600-mutation (a gene change within tumor cells). It is expected that the combination of these two medications that target the gene change and its cellular growth pathway will demonstrate clinical success when given as maintenance therapy following standard radiation therapy. Treatment on this study may last for approximately 2 years...
An Open-Label, Phase II Multicenter Study of Rituximab or Tocilizumab for Steroid-dependent or Steroid-refractory Immune-Related Adverse Events due to Immune Checkpoint Blockade.

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT04375228

Population:

Adult

Phase:

II

The purpose of this study is to determine the safety and effectiveness of two drugs, either rituximab or tocilizumab, in patients who develop side effects while on treatment with immunotherapy requiring prolonged steroids. Immune-related side effects are caused by activation of the immune system from treatment with immunotherapy. Both rituximab and tocilizumab have been given to patients with autoimmune diseases (diseases where the immune system is activated against normal organs). Immune-related side effects appear to closely mirror these autoimmune conditions. Are you Eligible? (Inclusion...
A SINGLE ARM, MULTICENTER, PHASE II, OPEN-LABEL TRIAL TO EVALUATE EFFICACY OF ISATUXIMAB IN PATIENTS WITH MONOCLONAL GAMMOPATHY OF RENAL SIGNIFICANCE

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT04614558

Population:

Adult

Phase:

II

The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with Monoclonal Gammopathy of Renal Significance (MGRS). Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treatMonoclonal Gammopathy of Renal Significance (MGRS). This means that the use of isatuximab in this study is considered ‘investigational’. Are you Eligible? (Inclusion Criteria) • Are you 18 years of age or older? • Do you have persistent renal...

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