Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Multiple Cancer Types
This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.
Bladder,
Cervical,
Colon,
Esophageal,
GIST,
Gastric/Gastroesophageal,
Gastrointestinal,
Head/Neck,
Liver,
Lung,
Non Small Cell,
Ovarian,
Rectal,
Urologic,
Uterine
II
Choe, Jennifer
NCT06126276
ECOGMDEAY191-N5
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 to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Multiple Cancer Types
This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called "study drugs" in this form.
The study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs
* How much of each study drug is in the blood at different times
* Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects)
* Compatible research to better understand the study drugs and HNSCC
The study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs
* How much of each study drug is in the blood at different times
* Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects)
* Compatible research to better understand the study drugs and HNSCC
Esophageal,
Head/Neck
II
Choe, Jennifer
NCT06769698
VICCHN24568
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Miscellaneous
Miscellaneous
The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.
Miscellaneous
I
Davis, Elizabeth
NCT06561685
VICC-DTPHI24160
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Miscellaneous
Miscellaneous
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).
Miscellaneous
I/II
Ciombor, Kristen
NCT05919264
VICCPHI24562
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
Lymphoma
Lymphoma
The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy.
The primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.
The primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.
Lymphoma
III
Jallouk, Andrew
NCT07479797
VICCCTT26011
Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Sarcoma
Sarcoma
The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
Sarcoma
N/A
Keedy, Vicki
NCT06617572
VICCSAR24510
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Multiple Cancer Types
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
Colon,
Lung,
Miscellaneous,
Pancreatic
I
Eng, Cathy
NCT06917079
VICCPHI25051
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.
Not Available
II/III
Schaffer, Kerry
NCT05987241
ALLUROA032103
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
