A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
This study is being done to find out if tucatinib with other cancer drugs works better than
standard of care to treat participants with HER2 positive colorectal cancer. This study will
also test what side effects happen when participants take this combination of drugs. A side
effect is anything a drug does to the body besides treating your disease.
Participants in this study have colorectal cancer that has spread through the body
(metastatic) and/or cannot be removed with surgery (unresectable).
Participants will be assigned randomly to the tucatinib group or standard of care group. The
tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group
will get either:
- mFOLFOX6 alone,
- mFOLFOX6 with bevacizumab, or
- mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs
given in this study are used to treat this type of cancer.
standard of care to treat participants with HER2 positive colorectal cancer. This study will
also test what side effects happen when participants take this combination of drugs. A side
effect is anything a drug does to the body besides treating your disease.
Participants in this study have colorectal cancer that has spread through the body
(metastatic) and/or cannot be removed with surgery (unresectable).
Participants will be assigned randomly to the tucatinib group or standard of care group. The
tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group
will get either:
- mFOLFOX6 alone,
- mFOLFOX6 with bevacizumab, or
- mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs
given in this study are used to treat this type of cancer.
Not Available
III
Not Available
NCT05253651
VICC-DTGIT23052
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2 Related Genetic Alterations (MK-6482-015)
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants
with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET),
von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor
(wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2) related
genetic alterations. The primary objective of the study is to evaluate the objective response
rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST
1.1) by blinded independent central review (BICR).
with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET),
von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor
(wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2) related
genetic alterations. The primary objective of the study is to evaluate the objective response
rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST
1.1) by blinded independent central review (BICR).
Not Available
II
Ramirez, Robert
NCT04924075
VICCMD2132
Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)
This trial will be a randomized controlled study comparing the efficacy and safety of
intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following
metastatic tumor resection which is the current standard of care.
intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following
metastatic tumor resection which is the current standard of care.
Not Available
III
Chambless, Lola
NCT04365374
VICC-DTNEU23344
Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients with Pancreatic Cancer That Has Spread with Inherited BRCA Mutations
Pancreatic
Pancreatic
This phase II trial studies whether adding pembrolizumab to olaparib (standard of care) works better than olaparib alone in treating patients with pancreatic cancer with germline BRCA1 or BRCA2 mutations that has spread to other places in the body (metastatic). BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. These proteins help repair damaged deoxyribonucleic acid (DNA) and, therefore, play a role in ensuring the stability of each cells genetic material. When either of these genes is mutated, or altered, such that its protein product is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to some types of cancer, including pancreatic cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Olaparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of pembrolizumab to the usual treatment of olaparib may help to shrink tumors in patients with metastatic pancreatic cancer with BRCA1 or BRCA2 mutations.
Pancreatic
II
Cardin, Dana
NCT04548752
SWOGGIS2001
Comparing the Outcome of Standard Systemic Therapy Only versus Standard Systemic therapy with either Surgery or Radiation Therapy, for Patients with Advanced Prostate cancer
Prostate
Prostate
This phase III trial compare the effects of adding definitive treatment (either radiation therapy or prostate removal surgery) to standard systemic therapy in treating patients with prostate cancer that has spread to other places in the body (advanced). Removing the prostate by either surgery or radiation therapy in addition to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
Prostate
III
Schaffer, Kerry
NCT03678025
SWOGUROS1802
Testing the Use of Steroids and Tyrosine Kinase Inhibitors with Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
Leukemia
Leukemia
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager (BiTE) that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
Leukemia
III
Mohan, Sanjay
NCT04530565
ECOGHEMEA9181
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
This phase III trial compares the addition of total ablative therapy to the usual systemic therapy versus the usual systemic therapy alone in treating patients with advanced colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. The addition of ablative local therapy to the usual approach of systemic therapy could be more effective than usual chemotherapy alone by increasing the life of patients with limited metastatic colorectal cancer.
Not Available
III
Not Available
NCT05673148
VICC-NTGIT23268
A Study of a New Way to Treat Children and Young Adults with a Brain Tumor Called NGGCT
Multiple Cancer Types
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patients response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work 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. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.
Germ Cell (Pediatrics),
Pediatrics
II
Esbenshade, Adam
NCT04684368
COGACNS2021
A Study of the Drugs Selumetinib versus Carboplatin/Vincristine in Patients with Neurofibromatosis and Low-Grade Glioma
Multiple Cancer Types
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work 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. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine.
Neuro-Oncology,
Pediatrics
III
Pastakia, Devang
NCT03871257
COGACNS1831
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) with One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.
Not Available
II
Tan, Alan
NCT03866382
ALLIANCEUROA031702
