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Cyto-KIK TRIAL: CYTO reductive surgery in Kidney cancer plus Immunotherapy (nivolumab) and targeted Kinase inhibition (cabozantinib)

Principal Investigator:

Mark N. Stein, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04322955

Population:

Adult

Phase:

II

The purpose of this study is to determine if the use of immunotherapy nivolumab and the targeted therapy cabozantinib prior to removal of the kidney will increase the number subjects who are without any visible kidney cancer in their body at some point during the course of treatment. The study will also evaluate the changes that nivolumab and cabozantinib cause in the cells adjacent to the tumor in order to understand how the study medicines work and how cancer cells become resistant to these medicines. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have...
Exploratory Phase II Study of LAnreotide in Metastatic Pheochromocytoma/PARAganglioma

Principal Investigator:

Antonio Tito Fojo, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03946527

Population:

Adult

Phase:

II

The purpose of this study is to assess the efficacy and safety profile of lanreotide (a somatostatin analog) in patients with advanced/metastatic pheochromocytoma or paraganglioma. You are being asked to participate in this study because you have metastatic pheochromocytoma or metastatic paraganglioma and you have never been treated with a somatostatin analogs. Taking part in this study may or may not make your health better. Approximately 40 individuals will be asked to participate in this study. Are you Eligible? (Inclusion Criteria) Are you at least 18 years of age? Do you have diagnosis...
Phase II Study of Axitinib (AG-013736) with Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma

Principal Investigator:

Antonio Tito Fojo, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03839498

Population:

Adult

Phase:

II

Axitinib (AG-013736) is an investigational (experimental) drug that is being studied in patients with metastatic pheochromocytoma/paraganglioma. The main goal of this study is to find out if axitinib is able to stop tumors from growing, or shrink tumors in patients with this type of cancer. Are you Eligible? (Inclusion Criteria) Age ≥ 18 years A life expectancy of at least 3 months ECOG performance status ≤ 2
A Phase 1, Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®819 in Subjects with Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

I

The purpose of this study is to assess whether an investigational drug called XmAb819 has any effects on Clear Cell Renal Cell Carcinoma, to determine if it is safe and well tolerated, and to determine the dosing schedule. The investigational drug will be given by intravenous (IV – into the vein) infusion over a 2 hour period. This study will also see how the body affects the study drug and how much study drug is in the blood (pharmacokinetics, or “PK”), how the drug affects the tumor and body (pharmacodynamics, or “PD”), and if the body develops antibodies...
A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients with Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT04028245

Population:

Adult

Phase:

I

The purpose of this study is to study two experimental drugs called canakinumab and spartalizumab produced by Novartis to see if: • It is safe and feasible to give canakinumab and spartalizumab prior to radical nephrectomy? • Canakinumab and spartalizumab can kill cancer cells and bring immune cells into the kidney cancer when hen given to human subjects prior to radical nephrectomy? You are being asked to participate in this study because you have localized kidney cancer and you are planned to have a radical nephrectomy. People who usually have this do not receive any additional...
AREN1921: Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Principal Investigator:

Justine Kahn, 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...
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...
An Open-label, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI9253, a Recombinant Newcastle Disease Virus Encoding Interleukin-12, in Combination with Durvalumab in Participants with

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04613492

Population:

Adult

Phase:

I

The purpose of this study is to find out if two drugs, MEDI9253 and durvalumab, will be safe for the treatment of solid tumors. MEDI9253 and durvalumab are types of cancer therapies that try to boost the immune system to fight cancer. MEDI9253 is an oncolytic virus (a virus that infects and breaks down cancer cells but not normal cells) and may also help the immune system recognize cancer cells to destroy. MEDI9253 is an experimental drug. This means that is has not been approved for treatment by any regulatory authority that regulates new medicines, such as the U.S. Food and Drug...
AREN1721: A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single AgentAxitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC)Across All Age Groups

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03595124

Population:

Pediatrics/Adult

Phase:

II

This phase 2 study is examining the best treatments for TFE/Translocation type Renal Cell Carcinoma (tRCC). The best treatment for this type of kidney cancer is not known. This study is looking at 3 different treatment plans and trying to determine which treatment plan will be best. Are you Eligible? (Inclusion Criteria) Patients must be at least 12 months of age Patients may be newly diagnosed or previously received treatment Patients must also meet all eligibility criteria as outlined in the study protocol
A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 Monotherapy and in Combination with Pembrolizumab in Subjects with Selected Advanced Solid Tumors

Principal Investigator:

Benjamin Izar, MD

Contact Number:

212-342-5162

NCT Number:

NCT05098132

Population:

Adult

Phase:

I

The main purpose of this study is to determine the highest dose of STK-012 that can be given safely alone and in combination with a standard dose of pembrolizumab in subjects with advanced solid tumors, this will be assessed in the dose escalation phase of the study. In the dose expansion phase of the study, the highest dose of STK-012 that can be safely given in combination with pembrolizumab, as determined in the dose escalation phase, will be given to more people for further study.STK-012 is a modified (changed in the laboratory) form of a cytokine (protein) called interleukin-2 (IL-2)...

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