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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/ |
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Multiple Cancer Types
The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.
Colon,
Esophageal,
GIST,
Gastric/Gastroesophageal,
Gastrointestinal,
Liver,
Pancreatic,
Rectal
I/II
Keedy, Vicki
NCT06630234
VICC-DTSAR24137P
Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs 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. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.
Not Available
III
Padmanabhan, Sekhar
NCT05863195
VICC-NTGIT23530
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Multiple Cancer Types
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
Breast,
Gastrointestinal,
Gynecologic,
Head/Neck,
Lung,
Melanoma,
Neuro-Oncology,
Sarcoma,
Urologic
II
Choe, Jennifer
NCT05564377
VICC-NTMDT23238
Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Sarcoma
Sarcoma
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.
Sarcoma
II
Shinohara, Eric
NCT04506008
VICCSAR2062
A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)
The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)
Not Available
I/II
Not Available
NCT07291076
VICCGIP25073
Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
Kidney (Renal Cell)
Kidney (Renal Cell)
Substudy 03C is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
The goal of substudy 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with clear cell renal cell carcinoma (ccRCC) who have recurrent disease during or after anti-programmed cell death 1/programmed cell death ligand 1 (PD-\[L\]1) adjuvant therapy.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study
The goal of substudy 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with clear cell renal cell carcinoma (ccRCC) who have recurrent disease during or after anti-programmed cell death 1/programmed cell death ligand 1 (PD-\[L\]1) adjuvant therapy.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study
Kidney (Renal Cell)
I/II
Rini, Brian
NCT07049926
VICCURO25011
An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
Miscellaneous
Miscellaneous
The primary objectives of this trial are to:
* Characterize the safety and tolerability of TEV-56278
* Determine the Recommended Phase 2 Dose (RP2D)
* Evaluate antitumor activity of TEV-56278 (Part 2 only)
* Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab
* Determine a RP2D of TEV-56278 in combination with pembrolizumab
The secondary objectives of this trial are to:
* Characterize the serum pharmacokinetics of TEV-56278
* Evaluate the antitumor activity of TEV-56278
* Determine the safety and tolerability of TEV-56278
* Evaluate other measures of antitumor activity of TEV-56278
* Evaluate anti-tumor activity
Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.
Participants who exhibit a favorable benefit risk profile at the end of the 12 month trial treatment period may be offered an opportunity for an extended treatment period in which they can be treated for a maximum of 12 additional months (up to 26 additional cycles of TEV-56278).
* Characterize the safety and tolerability of TEV-56278
* Determine the Recommended Phase 2 Dose (RP2D)
* Evaluate antitumor activity of TEV-56278 (Part 2 only)
* Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab
* Determine a RP2D of TEV-56278 in combination with pembrolizumab
The secondary objectives of this trial are to:
* Characterize the serum pharmacokinetics of TEV-56278
* Evaluate the antitumor activity of TEV-56278
* Determine the safety and tolerability of TEV-56278
* Evaluate other measures of antitumor activity of TEV-56278
* Evaluate anti-tumor activity
Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.
Participants who exhibit a favorable benefit risk profile at the end of the 12 month trial treatment period may be offered an opportunity for an extended treatment period in which they can be treated for a maximum of 12 additional months (up to 26 additional cycles of TEV-56278).
Miscellaneous
I
Johnson, Douglas
NCT06480552
VICC-DTPHI24182
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Miscellaneous
Miscellaneous
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:
* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan
* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan
* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan
* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan
* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
Miscellaneous
I/II
Cardin, Dana
NCT04657068
VICCGIP25035
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
Miscellaneous
Miscellaneous
The goal of this study is to test autologous logic-gated Tmod CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment and Apheresis in BASECAMP-1 (NCT04981119)
Preconditioning Lymphodepletion (PCLD) Regimen
Tmod CAR T cells at the assigned dose
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment and Apheresis in BASECAMP-1 (NCT04981119)
Preconditioning Lymphodepletion (PCLD) Regimen
Tmod CAR T cells at the assigned dose
Miscellaneous
I/II
Eng, Cathy
NCT06051695
VICCPHI24512
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Multiple Myeloma
Multiple Myeloma
The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.
Multiple Myeloma
N/A
Oluwole, Olalekan
NCT05346835
VICC-XDCTT24033
