A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Multiple Cancer Types
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.
Pediatric Lymphoma,
Pediatrics
III
Smith, Christine
NCT05675410
VICC-NTPED23306
The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
Miscellaneous
Miscellaneous
Chemotherapy drugs, used in the treatment of cancer, have the potential of inducing peripheral neuropathy (PN) as a side effect. This side effect is commonly referred to as CIPN, or chemotherapy-induced peripheral neuropathy.
The Lilac Glove and Boot devices apply a low pressure across the surface of the hands and feet, respectively, to reduce access of chemotherapy to the peripheral nerves on the hands and feet. The small amount of pressure reduces the level of chemotherapy reaching the peripheral nerves, hence increasing the likelihood of nerve preservation during treatment and thus may potentially temporarily prevent the onset of moderate to severe PN symptoms induced by chemotherapy in the hands and feet while receiving treatment
The Lilac Glove and Boot devices apply a low pressure across the surface of the hands and feet, respectively, to reduce access of chemotherapy to the peripheral nerves on the hands and feet. The small amount of pressure reduces the level of chemotherapy reaching the peripheral nerves, hence increasing the likelihood of nerve preservation during treatment and thus may potentially temporarily prevent the onset of moderate to severe PN symptoms induced by chemotherapy in the hands and feet while receiving treatment
Miscellaneous
III
Agarwal, Rajiv
NCT07142304
VICCSUPP25037
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.
Not Available
II
Not Available
NCT05828069
VICC-NTPED24012
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-nave Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
The aim of this study is to compare progression free survival (PFS) in treatment-nave participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
Not Available
III
Eng, Cathy
NCT06252649
VICC-DTGIT23266
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer
Not Available
II
Not Available
NCT06992258
VICCGI25032
DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
Neuro-Oncology
Neuro-Oncology
The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone.
Participants in the DOC1021 + pIFN + SOC arm will:
* Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection
* Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses
* Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections
Both arms of the trial will:
\- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation
Participants in the DOC1021 + pIFN + SOC arm will:
* Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection
* Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses
* Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections
Both arms of the trial will:
\- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation
Neuro-Oncology
II
Merrell, Ryan
NCT06805305
VICCNEU24587
A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Nave Adult Patients With Metastatic Uveal Melanoma
Melanoma
Melanoma
The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.
Melanoma
II/III
Johnson, Douglas
NCT06581406
VICC-DTMEL24090
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Head/Neck
Head/Neck
This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.
Head/Neck
II/III
Topf, Michael
NCT04333537
NRGHN006
A Phase Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Multiple Cancer Types
This is a double-blind, randomized, multiregion, comparative phase clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
Esophageal,
Gastric/Gastroesophageal
III
Gibson, Mike
NCT06532006
VICCGI24578
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Breast
Breast
The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer.
The names of the study drugs involved in this study are:
* Datopotamab deruxtecan (a type of antibody drug conjugate)
* Trastuzumab deruxtecan (a type of antibody drug conjugate)
The names of the study drugs involved in this study are:
* Datopotamab deruxtecan (a type of antibody drug conjugate)
* Trastuzumab deruxtecan (a type of antibody drug conjugate)
Breast
II
Abramson, Vandana
NCT06533826
VICC-ITBRE23546
