Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Multiple Cancer Types
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are
unable to receive additional anthracyclines, or in 2nd relapse.
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are
unable to receive additional anthracyclines, or in 2nd relapse.
Pediatric Leukemia,
Pediatrics
III
Smith, Christine
NCT05183035
VICCPED2237
Testing the use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)
This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation.
Not Available
II
Choe, Jennifer
NCT05638295
ECOGMDEAY191-E5
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors
Multiple Cancer Types
The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
Breast,
Cervical,
Gastrointestinal,
Gynecologic,
Head/Neck,
Lung,
Phase I,
Urologic
I
Berlin, Jordan
NCT05683418
VICC-DTPHI23103
Phase 1b Combo w/ Ribociclib and Alpelisib
Multiple Cancer Types
This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 treatment groups are
as follows:
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI, Novartis Pharmaceuticals
Corporation).
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY, Novartis Pharmaceuticals
Corporation).
as follows:
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI, Novartis Pharmaceuticals
Corporation).
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY, Novartis Pharmaceuticals
Corporation).
Breast,
Phase I
I
Abramson, Vandana
NCT05508906
VICCBREP2267
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109,
which is a recombinant humanized tetravalent antibody targeting the human death receptor 5
(DR5).
which is a recombinant humanized tetravalent antibody targeting the human death receptor 5
(DR5).
Not Available
I
Davis, Elizabeth
NCT03715933
VICCMDP2287
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
A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML
Multiple Cancer Types
Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)
followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label
crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a
randomized open-label crossover study comparing the final oral ASTX030 dose to SC
azacitidine. The duration of the study is expected to be approximately 48 months.
an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose
levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time)
followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label
crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a
randomized open-label crossover study comparing the final oral ASTX030 dose to SC
azacitidine. The duration of the study is expected to be approximately 48 months.
Leukemia,
Myelodysplastic Syndrome,
Phase I
I/II/III
Savona, Michael
NCT04256317
VICCHEMP19146
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
Avelumab with Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients with Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer
Breast
Breast
This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
Breast
II
Abramson, Vandana
NCT03971409
VICCBRE1987
