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CT Open to Enrollment

A Phase 2 Study of Ipatasertib in Combination with Pembrolizumab for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

This study is being done to evaluate if adding the drug ipatasertib to the usual approach is able to safely lower the chance of head and neck squamous cell cancer growing or spreading. This study aims to determine if this approach is better or worse than the usual approach.

The usual approach consists of treatment with immunotherapy using pembrolizumab. Pembrolizumab is approved by the U.S. Food and Drug Administration (FDA) and is administered through a vein in the arm.

A Phase 1/2, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Patients with Relapsed/Refractory Multiple Myeloma

This clinical trial is for men and women with relapsed or refractory (return of disease after treatment) multiple myeloma.
   
The purpose of this study is to see if an experimental drug called ISB 1442 is safe, how much ISB 1442 should be given, how it moves through the body, and how effective it is. Experimental means that ISB 1442 is not yet approved by the U.S. Food and Drug Administration (FDA). 
   

Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with Both Chronic Hepatitis B and HIV

This study is evaluating the experimental drug selgantolimod (SLGN) for patients with Chronic Hepatitis B (CHB) to try to prevent progression and reverse disease. 

Experimental means that SLGN has not yet been approved by the U.S. Food and Drug Administration (FDA). 

An open label, single arm study of the safety and antiretroviral activity of the combination of 2 long-acting broadly neutralizing antibodies plus an IL-15 superagonist complex in ART-treated adults living with HIV during analytical treatment interruption

The purpose of this research study is to evaluate whether the 3 experimental study drugs being tested, 3BN117-LS, 10-1074-LS and N-803, are safe and tolerable for participants with HIV. Experimental means that these drugs have not yet been approved by the U.S. Food and Drug Administration (FDA). This study will also look at how well HIV is controlled after stopping antiretroviral therapy (ART).

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease (STOMP)

The purpose of this study is to see if the drug tecovirimat helps people with mpox (formally known as monkeypox) heal faster. The study will also help us understand more about how human mpox causes disease and how the body fights off infection. 
   
Tecovirimat is approved by the U.S. Food and Drug Administration (FDA) for the treatment of smallpox and has been given safely to some people with mpox in the recent outbreak. It is considered investigational in this study as it has not yet been approved to treat mpox.
   

The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects with Primary Biliary Cholangitis (PBC) and Hepatic Impairment

This study ia evaluating the safety and efficacy of the study drug seladelpar in people with Primary Biliary Cholangitis (PBC) and abnormal liver function. This will be done by looking at how the study drug seladelpar affects PBC and observing changes in the laboratory tests that are used to monitor the severity of PBC and its prognosis.

The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

This study is being done to find better ways to diagnose, treat and prevent cancers in children, adolescents, and young adults. To do this, we need to learn more about cancers that happen to these groups. As most cancers that children get are rare, we can best learn by combining information from as many children with cancer as possible.

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

This study aims to improve outcomes for patients with NCI High Risk B-Cell Acute Lymphoblastic Leukemia (B-ALL) and patients with NCI Standard Risk B-ALL with high risk features. High risk features are when the leukemia has spread to the spinal fluid or testes, or one received steroid treatment before being diagnosed with leukemia.
   

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

The purpose of this study is to compare the effects (good and/or bad) of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST), which is used to treat prostate cancer. Standard systemic therapy includes Androgen Deprivation Therapy (ADT) with or without the use of chemotherapy. ADT is an antihormone therapy that’s main use is to treat prostate cancer.   

Phase 1 study of venetoclax/azacitidine or venetoclax in combination with ziftomenib (KO-539) or standard induction cytarabine/daunorubicin (7+3) chemotherapy in combination with ziftomenib for the treatment of patients with acute myeloid leukemia

This clinical trial is for men and women with newly diagnosed or relapsed/refractory acute myeloid leukemia.

The purpose of this study is to determine a safe dose of an investigational new drug (ziftomenib) in combination with other study drugs i.e., venetoclax and azacitidine or cytarabine plus daunorubicin. This will include an evaluation of side effects associated with ziftomenib in combination with the other study drugs and also aims to determine how ziftomenib works in combination with the other study drugs.