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KaCrole Higgins was diagnosed with breast cancer in 2020. “In May 2020, I found a lump in my breast. I cried. By June, it was diagnosed as breast cancer, triple positive, stage 1A. While getting this cancer diagnosis was devastating, it also became an opportunity. Suddenly, the cancer gave me clarity. It gave me clarity about what was important, what was good in my life, what was toxic in my life, and what I needed to do.” Click below to read more of KaCrole’s story |
If Landon Ryan had been diagnosed with bilateral retinoblastoma 10, 20 or 30 years ago, she might not be here today with nearly perfect vision.Thanks to recent improvements in the treatment for this rare form of cancer that almost exclusively affects children under the age of 5, the diagnosis had the power to change Landon’s life when she was 11 months old, but not to take it — or her eyesight. Click below to learn more about Landon and her story. https://momentum.vicc.org/2022/04/brighter-outlook/ |
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Breast
Breast
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
Breast
I/II
Rexer, Brent
NCT05563220
VICC-DTBRE23166P
SMP-3124LP in Adults With Advanced Solid Tumors
Multiple Cancer Types
An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors
Breast,
Head/Neck,
Lung,
Non Small Cell,
Ovarian,
Phase I,
Uterine
I/II
Eng, Cathy
NCT06526819
VICC-DTPHI23348
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Multiple Cancer Types
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.
The study will be performed in two stages. During Stage 1, six cohorts will be enrolled in parallel in this study:
Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort).
Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-nave cohort).
Cohort 3, 5, and 6 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.
Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).
In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-nave cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.
The study will be performed in two stages. During Stage 1, six cohorts will be enrolled in parallel in this study:
Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort).
Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-nave cohort).
Cohort 3, 5, and 6 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.
Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).
In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-nave cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.
Breast,
Phase I
I/II
Kennedy, Laura
NCT03424005
VICCBREP2126
A Multi-Institution Study of TGF Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination With Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Pediatric Bone and Soft Tissue
Multiple Cancer Types
The purpose of this study is to determine if the addition of infusions of a type of immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies.
The goals of this study are:
* To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGF imprinted (TGFi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
* To identify toxicities related to treatment with GEM/DOX + TGFi expanded NK cells
Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles.
* Gemcitabine (GEM): via IV on Days 1 and 8
* Docetaxel (DOX): via IV on Day 8
* Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction
* Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given
* TGFi NK cells: via IV on Day 12
The goals of this study are:
* To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGF imprinted (TGFi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
* To identify toxicities related to treatment with GEM/DOX + TGFi expanded NK cells
Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles.
* Gemcitabine (GEM): via IV on Days 1 and 8
* Docetaxel (DOX): via IV on Day 8
* Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction
* Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given
* TGFi NK cells: via IV on Day 12
Pediatrics,
Sarcoma
I/II
Borinstein, Scott
NCT05634369
VICCPED24617
Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
Multiple Cancer Types
This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone.
Miscellaneous,
Phase I
I/II
Davis, Elizabeth
NCT05691491
VICCPHI10572
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.
Not Available
I/II
Not Available
NCT04956640
VICCTHOP2155
A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers
Multiple Cancer Types
This study is researching an investigational drug called marlotamig (REGN7075) by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage.
The aim of the study is to see how safe and tolerable marlotamig is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of marlotamig to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective marlotamig by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients.
The study is also looking at:
* Side effects that may be experienced by people taking marlotamig by itself and in combination with cemiplimab with or without chemotherapy
* How marlotamig works in the body by itself and in combination with cemiplimab with or without chemotherapy
* How much marlotamig is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy
* To see if marlotamig by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor
* Whether the body makes antibodies against the study drugs (marlotamig and cemiplimab) (which could make the drug less effective or could lead to side effects)
The aim of the study is to see how safe and tolerable marlotamig is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of marlotamig to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective marlotamig by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients.
The study is also looking at:
* Side effects that may be experienced by people taking marlotamig by itself and in combination with cemiplimab with or without chemotherapy
* How marlotamig works in the body by itself and in combination with cemiplimab with or without chemotherapy
* How much marlotamig is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy
* To see if marlotamig by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor
* Whether the body makes antibodies against the study drugs (marlotamig and cemiplimab) (which could make the drug less effective or could lead to side effects)
Adrenocortical,
Bladder,
Breast,
Cervical,
Colon,
Esophageal,
GIST,
Gastric/Gastroesophageal,
Gastrointestinal,
Gynecologic,
Head/Neck,
Kidney (Renal Cell),
Liver,
Lung,
Miscellaneous,
Non Small Cell,
Ovarian,
Pancreatic,
Phase I,
Prostate,
Rectal,
Urologic,
Uterine
I/II
Choe, Jennifer
NCT04626635
VICC-DTPHI24031
Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation
Multiple Cancer Types
This phase I/II trial studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation \[TBI\]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy \[H-RT\]) combined with atezolizumab and chemotherapy (carboplatin \& etoposide) in treating patients with small cell lung cancer that has spread to disease sites outside of the lung (extensive stage). Extensive stage disease has historically been treated with chemotherapy alone with consideration of chest (thoracic) radiation therapy for those with response to chemotherapy, as well as consideration of preventative radiation therapy to the head (prophylactic cranial irradiation). Emerging evidence supports the synergistic interactions between immunotherapy and radiation therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. 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 tumor cells. Combining TBI and H-RT with atezolizumab and chemotherapy may improve response to treatment.
Lung,
Small Cell
I/II
Osmundson, Evan
NCT06110572
VICCTHOP2206
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Multiple Cancer Types
This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.
Head/Neck,
Phase I
I/II
Lockney, Natalie
NCT05156060
VICCHNP2173
A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis
Leukemia
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
