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A PHASE II RANDOMIZED, OPEN-LABEL, TRIAL OF NAB-PACLITAXEL + GEMCITABINE WITH OR WITHOUT BOTENSILIMAB (AGEN1181) IN PATIENTS WITH METASTATIC PANCREATIC CANCER WHO HAVE PROGRESSED ON PRIOR 5FU + LEUCOVORIN + IRINOTECAN + OXALIPLATIN (FOLFIRINOX)

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05630183

Population:

Adult

Phase:

II

The purpose of this study is to find out if study drug, botensilimab, when given in combination with chemotherapy consisting of nab-paclitaxel + gemcitabine, can help patients with metastatic pancreatic cancer. Botensilimab has not been approved by US Food and Drug Administration (FDA). Nab-paclitaxel + gemcitabine is an approved chemotherapy combination for pancreatic cancer, but they are not FDA approved to treat pancreatic cancer that has progressed after receiving initial treatment. This trial consists of two parts (Part 1 and Part 2). All visits and procedures are the same in both parts...
A phase 2 randomized study of osimertinib versus osimertinib plus chemotherapy for patients with metastatic EGFR-mutant lung cancers that have detectable EGFR mutant cfDNA in plasma after initiation of osimertinib treatment

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04410796

Population:

Adult

Phase:

II

This study will compare the effectiveness of osimertinib alone to the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene for the epidermal growth factor receptor (EGFR). Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. This study will be adding chemotherapy to osimertinib, which could possibly add to the anticancer effects of the usual treatment and may help stop cancer from growing or spreading. Osimertinib binds to the EGFR protein and blocks its activity,...
A Phase II Trial of JAK Inhibitor added to Immunotherapy for Treatment of Relapsed/Refractory T-cell Lymphomas and 9p Amplified Lymphomas

Principal Investigator:

Seda S Tolu, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

II

The purpose of this study is to understand and determine if ruxolitinib added to pembrolizumab is safe and effective for the treatment of relapsed or refractory Hodgkin and non-Hodgkin lymphomas. This includes peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphomas (CTCL), and other lymphomas (Hodgkin Lymphoma [HL], Gray Zone Lymphomas [GZL], and Primary Mediastinal B-cell Lymphoma [PMBCL]) that has become resistant to commonly available chemotherapy (refractory), or it has re- occurred after treatment (relapsed). For PTCL participants, the main goal is to see how many achieve complete...
A phase 2, randomized, open-label study of gemcitabine/cisplatin plus cemiplimab (REGN2810, anti-PD-1) with or without fianlimab (REGN3767, anti-LAG-3) for organ preservation in patients with localized muscle-invasive bladder cancer (NeoSTOP-IT)

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

II

This study is for patients with a localized bladder cancer called muscle-invasive bladder cancer. Muscle-invasive bladder cancer is usually treated with a combination of chemotherapy and surgery. This surgery removes the entire bladder, which changes how they urinate for the rest of their life. Some patients will have a small opening in the skin of their abdomen where urine will leave their body and go into a bag (this is called an ileal conduit). The goal of this study is to see if we can find ways of sparing patients from having to undergo this surgery. In this study, they will first...
A Phase II Trial of Tazemetostat Plus Mosunetuzumab In Untreated Follicular Lymphoma

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT05994235

Population:

Adult

Phase:

II

The purpose of this study is to test the efficacy of the combination of tazemetostat with mosunetuzumab and see what effects it has in your lymphoma. Tazemetostat is a drug that inhibits (reduces the ability of) EZH2, an enzyme known to drive the development of B-cell lymphomas, and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune system’s ability to fight it. Tazemetostat is Food and Drug Administration (FDA) approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas. Mosunetuzumab is a bispecific...
A Phase 2 Study of Glofitamab and Obinutuzumab for first-line treatment of follicular lymphoma and marginal zone lymphoma

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT05783596

Population:

Adult

Phase:

II

The purpose of this study is to determine how effective and safe the combination of glofitamab and obinutuzumab is in treating patients with Follicular Lymphoma (FL) and Marginal Zone Lymphoma(MZL) who have not received other treatments for their lymphoma. The investigators hope that combining these two drugs can provide a more effective study treatment regimen for these diseases. In addition, pre-study treatment with obinutuzumab may reduce side effects associated with glofitamab study treatment, like cytokine release syndrome. The U.S. Food and Drug Administration (FDA) has not approved...
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...
AALL1721: A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy

Principal Investigator:

Prakash Satwani, MD

Contact Number:

212-342-5162

NCT Number:

NCT03876769

Population:

Pediatrics/Adult

Phase:

II

The purpose of this study is to find out if the study drug, tisagenlecleucel, is safe and has benefits for people who have high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL) and have a tiny number of leukemia cells still present in their bone marrow (MRD positive) at the end of consolidation (EOC) therapy. Tisagenlecleucel is a product made up of the patient's own T cells that have been changed to be able to identify and kill leukemia cells. Patients will receive chemotherapy followed by tisagenlecleucel and then be monitored to see how well the treatment worked. Are you Eligible? (...
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...

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