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Open-Label, Phase 2 Study to Assess the Safety ofMogamulizumab Given Every 4 Weeks Following Induction inParticipants with Relapsed/Refractory Cutaneous T-CellLymphoma (CTCL)

Principal Investigator:

Larisa J. Geskin, MD

Contact Number:

212-342-5162

NCT Number:

NCT04745234

Population:

Adult

Phase:

II

Primary Objective: • To evaluate the safety and tolerability of mogamulizumab given every 4 weeks (Q4W) in participants with relapsed/refractory mycoses fungoides (MF) or Sézary syndrome (SS) subtypes of CTCL. Secondary Objectives: • To characterize the pharmacokinetics (PK) of mogamulizumab following 2 mg/kg Q4W intravenous (IV) administration. • To evaluate the anti-tumor activity of mogamulizumab in participants with relapsed/refractory MF and SS (overall response rate [ORR], duration of response [DOR], compartment response, time to next treatment [TTNT]) as assessed...
Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated with First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04533451

Population:

Adult

Phase:

II

This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with non-small cell lung cancer that has come back and has spread to other places in the body. Pembrolizumab is an immunotherapy that may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy works in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor...
Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

Principal Investigator:

Michael David Kluger, MD

Contact Number:

212-342-5162

NCT Number:

NCT03127774

Population:

Adult

Phase:

II

motherapy can improve survival in patients with metastatic adrenal cortical carcinoma. Are you Eligible? (Inclusion Criteria) * Histologically proven ACC with the majority of disease confined to the peritoneal cavity and resectable; or disease that in the opinion of the investigators can be managed medically or surgically and does not present an immediate threat to the patientâs life. * Disease evaluable by CT or PET imaging * All disease should be deemed resectable based on imaging studies e.g.: - Hepatic metastases (unilateral or bilateral â¤5 lesions, â¤...
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
Phase II, Neoadjuvant study of parasympathetic stimulation with bethanechol in combination with gemcitabine and nab-paclitaxel in borderline resectable pancreatic adenocarcinoma

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT05241249

Population:

Adult

Phase:

II

of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. Animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. The chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is FDA approved. Although bethanechol is FDA approved, in this study its use is experimental. The aim of the study is to show that...
Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer)

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT04266249

Population:

Adult

Phase:

II

This study is being done to answer the following question: Can participants with HER2-positive breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after 12 weeks of chemotherapy and two HER-targeted therapies eliminate further chemotherapy after surgery? This would be a decrease in the total number of chemotherapy drugs and the amount of chemotherapy typically received to treat this type of cancer. We are doing this study because we want to find out if this approach can enable you to take fewer chemotherapy drugs than the usual approach for...
Phase II study of Polatuzumab vedotin in combination with chemotherapy in subjects with Richter's Transformation

Principal Investigator:

Andrew H Lipsky, MD

Contact Number:

212-342-5162

NCT Number:

NCT04679012

Population:

Adult

Phase:

II

This research is being done because Richter’s transformation, which is a life- threatening complication of chronic lymphocytic lymphoma (CLL), and is associated with poor overall survival rate. The study drug administration is a combination of the investigational drug, Polatuzumab vedotin, in combination with Rituximab, Etoposide, Prednisone, Cyclophosphamide, and Hydroxydaunorubicin, also referred to as PolaR-EPCH. An investigational drug means it has not been approved by the FDA or any other international regulatory agencies. The purpose of this study is to find out what effects the...
Pembrolizumab in combination with gemcitabine for previously treated mycosis fungoides and Sezary syndrome: efficacy and characterization of immune response

Principal Investigator:

Larisa J. Geskin, MD

Contact Number:

212-342-5162

NCT Number:

NCT04960618

Population:

Adult

Phase:

II

Primary objective: Determine preliminary clinical effectiveness of pembrolizumab plus gemcitabine in previously treated MF and SS with overall response rate (ORR) using the composite global response criteria including: radiological imaging (PET/CT scans), flow cytometry and mSWAT assessments. 2. Secondary objectives: a. To estimate duration of response (DOR) of pembrolizumab plus gemcitabine in previously treated MF and SS. b. To estimate progression-free survival (PFS) pembrolizumab plus gemcitabine in previously treated MF and SS. c. To estimate overall survival (OS) of patients with...
Phase II single arm study testing SBRT, Adenosine signaling Modulation (AB680, AB928), and Immune Checkpoint inhibition (AB122) for men with hormone sensitive Oligometastatic prostate cancer (SBRT-AMICO)

Principal Investigator:

Catherine S Spina, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05915442

Population:

Adult

Phase:

II

This study aims to test the safety and effectiveness of zimberelimab, etrumadenant, and quemliclustat when given together with radiotherapy as a potential treatment to hormone sensitive oligometastatic (cancer that has spread to other areas of the body) prostate cancer. Zimberelimab, etrumadenant, and quemliclustat are considered immunotherapy drugs. These type of drug works by blocking a protein that can cause tumors to grow. By blocking this protein, the study drugs may cause your cancer to stop growing or to shrink. These study drugs are not approved by Health Authorities including the...
Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway Mutations

Principal Investigator:

Mary R. Welch, MD

Contact Number:

212-342-5162

NCT Number:

NCT02523014

Population:

Adult

Phase:

II

The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with meningioma. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a...

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