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Diversity & IncluSion in Research Underpinning Prevention & Therapy Trials
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Diversity & Inclusion in Scientific Research Underpinning Prevention & Therapy Trials
Liver Cancer Trials
Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination with Nivolumab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma (RELATIVITY-106)
This is a safety and efficacy study to evaluate a drug called relatlimab in combination with two other drugs, nivolumab and bevacizumab, for the treatment of people with advanced or metastatic hepatocellular carcinoma, a type of liver cancer. The main goal is to confirm that the drug combination is safe for people to take. Neither the patients nor the doctors will know who is taking the actual drug combination and who is taking a placebo. Patients will be randomly assigned to either the drug combination group or the placebo group. The investigational drug being studied is relatlimab, an immunotherapy drug that helps the immune system attack cancer cells. Nivolumab is another immunotherapy drug already approved for some cancers. Bevacizumab is a drug that blocks the growth of new blood vessels that tumors need to grow. The study is only for people who have not previously been treated for their hepatocellular carcinoma.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body.
Advanced:
Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
A placebo is a substance or treatment that has no active medical properties but is given to a patient as if it were a real medication or treatment. It is often used in medical research to compare the effects of a new drug or treatment with the effects of no treatment at all. The idea is to see if the new drug or treatment is genuinely effective by comparing how patients who receive the real treatment fare compared to those who receive the placebo
Placebo:
Site:
Einstein
NCT Number:
Tislelizumab Consolidation after Liver-Directed Therapy for Hepatocellular Carcinoma (Phase II Study)
This is a research study to evaluate the safety and efficacy of tislelizumab in combination with other liver-directed therapies for the treatment of hepatocellular carcinoma (HCC), a type of liver cancer. The study is in phase II, which means it is in its early stages and researchers are trying to determine the safety and effectiveness of the treatment. The treatment being studied is tislelizumab, a drug that is designed to help the immune system attack cancer cells. Tislelizumab is being combined with other liver-directed therapies, which are treatments that target the liver. The study is for people with hepatocellular carcinoma.
Site:
Einstein
NCT Number:
A Multi-Cohort Exploratory Study of Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC.
Some patients have a tumor that is “resectable,” which means that it is able to be removed with surgery. For these cases, doctors have created the medicine called Cemiplimab, which can treat cancer by working with your immune system. This research study will study how well the drug Cemiplimab works on resectable Hepatocellular carcinoma (HCC) and other cancers. Cemiplimab is a monoclonal antibody which is an immune therapy. The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing. Doctors will measure how well this treatment works on delaying potential surgery and how the immune system responds after taking this medicine.
Site:
Mount Sinai
NCT Number:
A Phase 1 Study of SRF388 in Patients with Advanced Solid Tumors
Antibodies are part of our body's defense system. They can specifically recognize damaging substances in the body, including tumor cells. The drug SFR338 is a new immune therapy drug that works with the body’s immune system, turning it on and fighting tumors from growing. This clinical trial will study the effects and benefits of the drug SRF388, when given by itself or combined with other types of medicine, in patients with solid tumors like hepatocellular carcinoma (liver cancer).
Site:
Mount Sinai
NCT Number:
A Phase 1/1b Dose Escalation/Expansion Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors
This is an early-stage medical study for an investigational drug called NGM438, either alone (monotherapy) or in combination with another drug called pembrolizumab. The goal of the study is to determine the safety and effectiveness of NGM438 in treating people with advanced or metastatic solid tumors, which are cancers that have spread to other parts of the body. The study is being conducted in two parts: Part 1a: This is a dose-escalation study, where researchers will determine the safest and most effective dose of NGM438 when given as a monotherapy. Part 1b: This part of the study will evaluate the safety and effectiveness of NGM438 in combination with pembrolizumab. Pembrolizumab is a type of immunotherapy drug that helps the immune system attack cancer cells. The study is open to adults who have advanced or metastatic solid tumors and who have not received prior treatment with an anti-PD-1 or anti-PD-L1 therapy.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body.
Early Stage:
Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.
Site:
Mount Sinai
Advanced:
Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
NCT Number:
A first-in-human, phase 1/2, open-label, multi-center, dose-escalation and dose-expansion study to evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity of the ATR inhibitor IMP9064 monotherapy and in combination with PARP inhibitor senaparib in patients with advanced solid tumors
This is an early-stage, first-in-human medical study that aims to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of an investigational drug called MP964. MP964 is an ATR inhibitor, a type of drug that targets a protein involved in DNA damage repair in cancer cells. By inhibiting this protein, MP964 may be able to help kill cancer cells. The study is open to adults with advanced solid tumors who have not received prior treatment with an ATR inhibitor. The study will be conducted in two parts: Part 1: This is a dose-escalation phase, where researchers will determine the safest and most effective dose of MP964.
Part 2: This is a dose-expansion phase, where researchers will further evaluate the safety and effectiveness of MP964 at the chosen dose from Part 1 in a larger group of patients. The study will also collect and analyze tumor tissue to understand how MP964 works.
Advanced:
Advanced means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
Early Stage:
Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.
Site:
Mount Sinai
NCT Number:
A First-In-Human, Phase 1 a/b Dose Escalation and Expansion Study to Evaluate RBS2418 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Unresectable, Recurrent or Metastatic Tumors
RBS2418 (investigational product) is a specific immune modulator, working through ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine production in the tumors. RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with checkpoint blockade. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors.
Immunomodulators:
Immunomodulators are medicines that change your immune system so it works more effectively. They include treatments that increase or decrease your immune response.
Site:
Mount Sinai
NCT Number:
A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients With HER2-Expressing Advanced Solid Tumors
This is an early-stage medical study that is designed to evaluate the safety, tolerability, and preliminary efficacy of an investigational drug called IMM2902.
IMM2902 is a type of drug called an antibody-drug conjugate (ADC). ADCs are made up of two parts: an antibody that targets a specific protein on cancer cells and a drug that kills the cancer cells. The HER2 protein is found in high levels in many types of cancer, including breast, ovarian, and bladder cancer. IMM2902 is designed to target the HER2 protein and deliver the drug to the cancer cells. The study is open to adults with advanced solid tumors that express the HER2 protein and who have not received prior treatment with an ADC. The study will be conducted in two parts:
Part 1: This is a dose-escalation phase, where researchers will determine the safest and most effective dose of IMM2902.
Part 2: This is a dose-expansion phase, where researchers will further evaluate the safety and effectiveness of IMM2902 at the chosen dose from Part 1 in a larger group of patients.
Site:
Mount Sinai
NCT Number:
A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study of IO-202 in Combination with Pembrolizumab in Subjects with Advanced, Relapsed, or Refractory Solid Tumors
This is an early-stage, open-label, multicenter medical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of IO-202, either alone (monotherapy) or in combination with pembrolizumab. IO-202 is an investigational drug called a bispecific T cell engager (BiTE). BiTEs are designed to link T cells, a type of immune cell, to cancer cells, which helps the immune system kill the cancer cells. Pembrolizumab is a type of immunotherapy drug called a PD-1 inhibitor. It helps the immune system attack cancer cells by blocking a protein called PD-1 that can sometimes hide cancer cells from the immune system. The study is open to adults with advanced, relapsed, or refractory solid tumors who have not received prior treatment with a BiTE or anti-PD-1 therapy. The study will be conducted in two parts:
Part 1: This is a dose-escalation phase, where researchers will determine the safest and most effective dose of IO-202, either alone or in combination with pembrolizumab.
Part 2: This is a dose-expansion phase, where researchers will further evaluate the safety and efficacy of IO-202 at the chosen dose from Part 1 in a larger group of patients with specific tumor types.
Open-Label:
Early Stage:
Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.
Patients know which treatments are being given to them
Site:
Mount Sinai
NCT Number:
A Phase 1 Study Investigating AGEN1571 as a Single Agent and in Combination with a PD-1 Inhibitor and/or Botensilimab (AGEN1181) in Patients with Advanced Solid Tumors
This is an early-stage, open-label medical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of LY3176150, an investigational drug, in combination with pembrolizumab. LY3176150 is a type of drug called a RET inhibitor. RET inhibitors target a protein called RET, which can play a role in the growth and survival of cancer cells. Pembrolizumab is a type of immunotherapy drug called a PD-1 inhibitor. It helps the immune system attack cancer cells by blocking a protein called PD-1 that can sometimes hide cancer cells from the immune system. The study is open to adults with advanced solid tumors who have not received prior treatment with a RET inhibitor or anti-PD-1 therapy.
Open-Label:
Early Stage:
Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.
Patients know which treatments are being given to them
Site:
Mount Sinai
NCT Number:
A 2-Part Open-Label Phase I Study of TAVO412 in Patients with Advanced or Metastatic Solid Tumors who progressed on prior approved standard of care therapy
This medical study involves two parts and is looking at a new treatment called TAVO412. The study is open-label, meaning everyone knows what treatment they're getting. It's in Phase I, which is an early stage to test safety. They are studying patients with advanced or spreading solid tumors who haven't responded well to standard treatments that are already approved. The goal is to see if TAVO412 is safe and potentially helpful for these patients.
Advanced:
Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
Site:
Mount Sinai
NCT Number:
A Phase I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy with Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Advanced Solid Tumor Malignancies
This medical study is designed to study the safety, tolerability, and pharmacokinetics of ZL-1218, a new drug that is being developed to treat advanced solid tumors. The drug will be given to patients in two ways: either as a single agent or in combination with an anti-PD-1 antibody. Anti-PD-1 antibodies are a type of immunotherapy that work by blocking a protein called PD-1, which helps cancer cells evade the immune system. By blocking PD-1, anti-PD-1 antibodies can help the immune system to attack and kill cancer cells.
Advanced:
Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
Site:
Mount Sinai
NCT Number:
A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer
This medical study is looking at the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of AGEN1181, an investigational drug, either alone (monotherapy) or in combination with AGEN2034. AGEN1181 is an Fc-engineered anti-CTLA-4 monoclonal antibody. CTLA-4 is a protein that helps cancer cells evade the immune system. AGEN1181 is designed to block CTLA-4, which may help the immune system attack and kill cancer cells. AGEN2034 is an anti-PD-1 monoclonal antibody. PD-1 is another protein that helps cancer cells evade the immune system. AGEN2034 is designed to block PD-1, which may also help the immune system attack and kill cancer cells. The study is being conducted in adult participants with advanced solid tumors who have not responded well to standard treatments.
It’s an open-label, multicenter study, meaning participants will know what drugs they’re taking and the study will be conducted at multiple medical centers.
Advanced:
Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
Open-Label:
Patients know which treatments are being given to them
Site:
Mount Sinai
NCT Number:
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination with Pembrolizumab in Advanced Solid Tumors
This medical study is designed to study XmAb 662, a new drug that is being developed to treat advanced solid tumors. The drug will be given to patients in two ways: either as a single agent (monotherapy) or in combination with pembrolizumab. Pembrolizumab is a type of immunotherapy drug called a PD-1 inhibitor. It works by blocking a protein called PD-1, which helps cancer cells evade the immune system. By blocking PD-1, pembrolizumab can help the immune system attack and kill cancer cells.
Advanced:
Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
Site:
Mount Sinai
NCT Number:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
This is a research study for a new treatment for liver cancer. The trial is designed to compare the effectiveness of a three-drug combination with a placebo in patients with untreated liver cancer. The three drugs being studied are atezolizumab, bevacizumab, and tiragolumab. Atezolizumab is an immune checkpoint inhibitor, bevacizumab targets a protein that helps tumors grow new blood vessels, and tiragolumab is an investigational drug that is thought to work by stimulating the immune system to fight cancer.
Placebo:
A placebo is a substance or treatment that has no active medical properties but is given to a patient as if it were a real medication or treatment. It is often used in medical research to compare the effects of a new drug or treatment with the effects of no treatment at all. The idea is to see if the new drug or treatment is genuinely effective by comparing how patients who receive the real treatment fare compared to those who receive the placebo
Site:
Einstein
Checkpoint Inhibitor:
The immune system can help fight cancer. Drugs called “checkpoint inhibitors” work by releasing a natural brake on your immune system so that immune cells can recognize and attack tumors.
NCT Number:
PHASE Ib/II, OPEN-LABEL, MULTICENTER,RANDOMIZED PLATFORM STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT IMMUNOTHERAPY COMBINATIONS IN PATIENTS WITH SURGICALLY RESECTABLE HEPATOCELLULAR CARCINOMA (MORPHEUS-NEO HCC)
This is a resarch study that is designed to test new drug combinations for treating liver cancer (hepatocellular carcinoma) in people who can have surgery to remove the cancer. The treatments being tested in this study are immunotherapy combinations. Immunotherapy helps the body’s immune system recognize and attack cancer cells. This is an open label, multi-centre and randomized phase 1b/II study.
Randomized:
Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment
Open-Label:
Patients know which treatments are being given to them
Mount Sinai
NCT Number:
Site:
Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer (NAPOLI-2)
This is a research study called NAPOLI-2. It is designed to see how well a specific treatment combination works for people with advanced biliary tract cancer (BTC) who have already been treated with other medications. The treatments used are: Fluorouracil (5-FU): This is a chemotherapy medication that works by interfering with the growth of cancer cells. Leucovorin (LV): This medication helps enhance the effects of 5-FU. Nanoliposomal irinotecan (nal-IRI): This is a type of medication that delivers the chemotherapy drug irinotecan directly to cancer cells.This study is phase II, open label and single arm.
Biliary tract cancer:
This is a cancer that forms in the bile ducts, which are tubes that carry bile from the liver and gallbladder to the small intestine
Open-Label:
Patients know which treatments are being given to them
A study where sample of individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.
Single Arm:
An advanced point of testing, where they're trying to confirm if a treatment works well.
Phase 2:
Site:
Mount Sinai
NCT Number:
A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy in Adult Subjects with Advanced Solid Tumors with MAPK Pathway Mutations.
This is a Phase 1 research study where researchers are testing a new drug called D3S-002 on adults who have advanced solid tumors. The study is "open-label," meaning both the researchers and the participants know which treatment is being administered. The specific focus is on adults who have solid tumors that contain mutations in the MAPK pathway. This pathway is important because it regulates cell growth and division, and mutations can contribute to cancer development. The researchers want to see if D3S-002 can be effective against these tumors and learn more about how it works in the body.
First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.
Phase 1:
Site:
Mount Sinai
NCT Number:
IMbrave152: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab And Bevacizumab, With or without Tiragolumab, in Patients with Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma ("SKYSCRAPER-14").
This is a Phase III research study called IMbrave152, also known as "SKYSCRAPER-14." It's a large-scale study designed to compare different treatment combinations for patients who have not received any prior treatment for their locally advanced or metastatic hepatocellular carcinoma (a type of liver cancer). Atezolizumab and Bevacizumab are two drugs that work in different ways to fight cancer. Atezolizumab boosts the immune system's ability to attack cancer cells, while bevacizumab targets the blood vessels that supply nutrients to tumors, which can help shrink them. Tiragolumab is another drug being tested in this trial. It's being evaluated to see if adding it to atezolizumab and bevacizumab improves treatment outcomes compared to using atezolizumab and bevacizumab alone. The study is "randomized," meaning patients are randomly assigned to one of the treatment groups. It's "double-blind," which means neither the patients nor the researchers know who is receiving which treatment (either the actual drugs or a placebo for comparison). This helps ensure unbiased results in evaluating how effective and safe each treatment combination is. The goal of IMbrave152 is to determine which combination of these drugs provides the best outcomes in terms of shrinking tumors, prolonging survival, and maintaining quality of life for patients with advanced liver cancer who have not yet been treated with any other therapies.
A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment
Phase III:
Site:
Einstein
NCT Number:
A PHASE II, OPEN-LABEL, MULTI-COHORT, MULTICENTER STUDY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA AND CHILD-PUGH B7 AND B8 CIRRHOSIS
This is a Phase II research study that is designed to investigate the effectiveness and safety of a treatment in a specific group of patients. The study is specifically targeting patients who have liver cancer (hepatocellular carcinoma) that cannot be removed by surgery (unresectable). These patients also have cirrhosis of the liver classified as Child-Pugh B7 or B8. Child-Pugh scoring is used to assess the severity of liver cirrhosis, with B7 and B8 indicating moderate to severe impairment of liver function. The main goal of this study is to evaluate how well the treatment works in these patients with advanced liver cancer and impaired liver function, while also assessing its safety profile. The treatment being tested could be a new drug, a combination of drugs, or a different therapeutic approach aimed at improving outcomes for this specific group of patients.
An advanced point of testing, where they're trying to confirm if a treatment works well.
Phase 2: