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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...
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...
A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)

Principal Investigator:

David P. Horowitz, MD

Contact Number:

212-342-5162

NCT Number:

NCT04166318

Population:

Adult

Phase:

II

This study is being done to answer the following question: Is using a lower-dose regimen of chemoradiation therapy as effective and does it have fewer side effects, compared to the standard-dose regimen of chemoradiation therapy for patients with anal 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 anal cancer. There is not an established treatment that is individualized for patients with early-stage anal cancer. However, the usual approach is defined as care most people get for anal cancer. Are you Eligible? (...
AAML18P1: Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03817398

Population:

Pediatrics/Adult

Phase:

II

This is a pilot study in pediatric and young adult patients with chronic phase CML (CML-CP) who are currently being treated with a tyrosine kinase inhibitor (TKI). Treatment with a TKI is currently life long. Pediatric patients with CML have long life spans, therefore they will be taking a TKI for a long time, especially during periods of growth and development, and therefore are believed to be at a significantly increased risk for side effects. Patients in this study will stop taking TKI medication and be closely monitored for 3 years to see if they remain cancer free. If their CML returns,...
AREN1921: Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04322318

Population:

Pediatrics/Adult

Phase:

II

This is a Phase 2 study of patients for the treatment of patients with high risk Wilms tumors (including those with diffuse anaplastic Wilms tumor- DAWT) and those who have relapsed favorable histology Wilms tumor (FHWT). The main goal of the study is to find out whether treatment with chemotherapy consisting of vincristine/irinotecan; cyclophosphamide/carboplatin/etoposide; and vincristine/doxorubicin/cyclophosphamide) improves the survival of patients with newly diagnosed Stage 4 diffuse anaplastic Wilms tumor (DAWT) or Standard-Risk relapsed favorable histology Wilms tumor (SRrFHWT) as...
AALL1821: A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC# 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to <31 Years Old with First Relapse

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04546399

Population:

Pediatrics/Adult

Phase:

II

This is a study looking at how well the combination treatment of Blinatumomab and Nivolumab works in patients with first relapse of B-cell Acute Lymphoblastic Leukemia (B-ALL) as compared to treatment with only Blinatumomab. In addition, it is looking at what effects, good and/or bad the treatment has. First relapse means that B-ALL has come back after the initial treatment a patient received for B-ALL. All patients will receive treatment with Blinatumomab, an antibody (protein) that targets a marker on B-ALL cells and then uses your immune system to kill the B-ALL cell. Some patients will...
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...

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