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A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB VERSUS SOTORASIB OR ADAGRASIB IN PATIENTS WITH PREVIOUSLY TREATED KRAS G12C-POSITIVE ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06497556

Population:

Adult

Phase:

III

The purpose of this study is to evaluate how well and how safely the experimental drug, divarasib, works compared to other approved drugs for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a mutation in the kirsten rat sarcoma virus (KRAS) G12C gene. This gene mutation drives cancer growth. The other approved treatments are sotorasib or adagrasib. The study drug, divarasib, is experimental, meaning it has not yet been approved by the U.S. Food and Drug Administration. While several drugs targeting this gene mutation have recently been developed, there is still...
A Multinational, Multicenter, Prospective, Open-Label, Dosimetry and Safety Study of Lutetium (177Lu) rosopatamab tetraxetan in Combination with Standard of Care in Patients with PSMA Positive Metastatic Castration-Resistant Prostate Cancer after Androgen

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06520345

Population:

Adult

Phase:

III

This study aims to explore a possible new treatment for advanced prostate cancer that has spread to other parts of the body and tests positive for a specific protein called PSMA (prostate-specific membrane antigen). This treatment involves a special drug that seeks out cancer cells by recognizing PSMA on their surface. The drug combines an antibody— a molecule that can find and attach to specific targets on cancer cells—with a radioactive component. Once attached, it delivers radiation directly to the cancer cells to help destroy them. The drug being studied is called 177Lu-TLX591...
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT06608927

Population:

Adult

Phase:

III

The purpose of this research is to determine the safety and efficacy of investigational study drug quemliclustat (also known as AB680) in combination with chemotherapy gemcitabine and nab-paclitaxel (Gem-NP), compared to a placebo (saline solution not containing treatment drug) in combination with chemotherapy gemcitabine and nab-paclitaxel at treating participants with the type of cancer you have. Quemliclustat has not been approved by the Food and Drug Administration (FDA). Gemcitabine and nab-paclitaxel (Gem-NP) is FDA approved but not in combination with quemliclustat. This is a double-...
A Phase 3 Open-label, Randomised Study of DatopotamabDeruxtecan (Dato-DXd) With or Without Durvalumab VersusInvestigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual InvasiveDisease in the Breast

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05629585

Population:

Adult

Phase:

III

The purpose of this study is to learn more about whether an investigational drug called datopotamab deruxtecan (also called Dato-DXd), either alone or in combination with another investigational drug called durvalumab, will work and be safe for the treatment of Triple Negative Breast Cancer TNBC. The term TNBC refers to the fact that the cancer cells do not have estrogen or progesterone receptors (ER or PR) and also do not make any or much of the protein called HER2 (human epidermal growth factor receptor 2). (The cells test negative on all 3 tests.) TIn this study, we will be comparing the...
AAML1831: A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04293562

Population:

Pediatrics

Phase:

III

This is a Phase 3 trial that will compare the efficacy of CPX-351 (a combination of 2 standard chemotherapy medicines - Daunorubicin and Cytarabine) compared to standard chemotherapy in the treatment of Acute Myelogenous Leukemia (AML). Patients will be randomly assigned by a computer to receive treatment with either CPX-351 treatment regimen or the standard chemotherapy regimen. In addition, if testing shows that a patient's AML has a specific gene change (FLT3), then those patients will be offered treatment with a new medicine (Gilteritinib) that targets the FLT3 gene change. For all...
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06112314

Population:

Adult

Phase:

III

The purpose of this study is to see if IMC-F106C, in combination with nivolumab, works better than the standard therapy (nivolumab alone or in combination with relatlimab) at making tumors stop growing or shrink. IMC-F106C has not yet been approved by the Food and Drug Administration (FDA). Nivolumab and the combination of nivolumab + relatlimab is FDA approved but not in combination with IMC-F106C. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Must be HLA-A*02:01-positive - Must have a life expectancy of at least 3 months
A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO*) *Her2 Radiation Optimization (HERO)

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05705401

Population:

Adult

Phase:

III

This study is being done to answer the following question: Is treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients with HER2-positive breast cancer who have had surgery, chemotherapy, and HER2-targeted therapy? This study is being done to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach for patients who have undergone surgery, chemotherapy, and HER2-targeted therapy and are not in a study is treatment with radiation therapy to the breast...
A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared With Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06346392

Population:

Adult

Phase:

III

The purpose of this study is to learn more about the effectiveness and safety of the study drug AZD0901 compared to standard therapy drugs (Ramucirumab, Paclitaxel, Docetaxel, Irinotecan, and TAS-102). AZD0901 is a type of drug known as an Antibody Drug Conjugate (abbreviated to ADC). AZD0901 recognizes cancer cells by specific protein called Claudin 18.2 (CLDN 18.2). CLDN 18.2 is one of the proteins that is expressed on the surface of gastric cancer cells. AZD0901 binds to CLDN 18.2 on the cancer surface and is taken into the cell where it releases the anti-cancer drug with the goal to stop...
Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT03937635

Population:

Adult

Phase:

III

The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period of time in which patients are free of multiple myeloma symptoms differs between the two treatment groups. Daratumumab is already approved by the FDA for use in combination with lenalidomide and dexamethasone in people who have received at...
Elacestrant versus Standard Endocrine Therapy in Women and Men with Node positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

Principal Investigator:

Claire Sathe, MD

Contact Number:

212-342-5162

NCT Number:

NCT06492616

Population:

Adult

Phase:

III

The purpose of this study is to test a new endocrine therapy, called elacestrant, that may stop hormones from attaching to cancer cells and helping them grow. Researchers would like to understand if switching standard treatment to elacestrant (the study drug) will help to slow down or stop the growth of cancer. Treatments for early breast cancer include endocrine therapy, also called hormone therapy. Endocrine therapies work by blocking hormones from reaching the cancer cells or by reducing the amount of hormones the body makes. Are you Eligible? (Inclusion Criteria) Must be 18 years old or...

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