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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

Multiple Cancer Types

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Colon, Rectal
II/III
Ciombor, Kristen
NCT05174169
SWOGGI008

International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

Miscellaneous

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.

InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments:

A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).

After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either:

P. prophylactic PLND Q. no prophylactic PLND
Miscellaneous
III
Rini, Brian
NCT02305654
ECOGUROEA8134

(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

Head/Neck

The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer.

Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions.

Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).
Head/Neck
I
Topf, Michael
NCT05747625
VICCHN2279

Cemiplimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery

Head/Neck

This phase II trial tests how well cemiplimab works in treating basal cell carcinoma of the head and neck that has spread to nearby tissue or lymph nodes (locally advanced) before surgery (neoadjuvant). Cemiplimab is a human recombinant monoclonal IgG4 antibody that may allow the body's immune system to work against tumor cells. Giving cemiplimab before surgery may make the tumor smaller and make it easier to remove.
Head/Neck
II
Topf, Michael
NCT05929664
VICC-ITHAN23127

A Study of CBX-250 in Participants With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Multiple Cancer Types

Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS and CMML. Participants aged 12 years are planned to be enrolled. CBX-250 will initially be investigated on a fixed step-up dosing schedule. CBX-250 will be administered subcutaneously in 28-day cycles, with the first study drug dose administered on Cycle 1, Day 1. Cycle 1 will consist of a priming phase over 7 days, and a target phase over 28 days. Participants will continue CBX-250 until progressive disease (PD) or unacceptable toxicity. All subsequent treatment cycles will be 28 days.
Leukemia, Myelodysplastic Syndrome
I
Ball, Somedeb
NCT06994676
VICCHEMP25017

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Breast

This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer.

The study drugs involved in this study are:

* A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO)
* Hormonal (endocrine) Treatment
Breast
II
Abramson, Vandana
NCT04569747
VICCBRE2243

Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Lung

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
Lung
II
Ramirez, Robert
NCT04665739
SWOGTHOA021901

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

Multiple Cancer Types

Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM).
Multiple Myeloma, Phase I
I
Dholaria, Bhagirathbhai
NCT04960579
VICCCTTP2232

ResQ201A: Clinical Trial Of N-803 Plus TISLELIZUMAB And DOCETAXEL Versus DOCETAXEL Monotherapy In Participants With Advanced Or Metastatic Non-Small Cell Lung Cancer

Lung

This is a randomized, open-label, phase 3 clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (experimental arm) versus docetaxel monotherapy (control arm). Enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. Participant randomization will be stratified by geographical region (North America vs Europe vs ASIA vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA); (epidermal growth factor receptor \[EGFR\]/anaplastic lymphoma kinase \[ALK\] vs OTHER AGA vs No AGA).
Lung
III
Wang, Shuai
NCT06745908
VICCTHO24569

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

Leukemia

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.
Leukemia
I/II
Kishtagari, Ashwin
NCT04176198
VICC-DTHEM23002P

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