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A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy andSafety of Olomorasib in Combination with Standard of Care Immunotherapy in Participants withResected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer -

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06890598

Population:

Adult

Phase:

III

The purpose of this research study is to learn more about a new medicine called olomorasib, to see if it can help treat lung cancer. We want to see if olomorasib, when used along with standard immunotherapy (pembrolizumab or durvalumab), works well for people with a certain type of lung cancer called KRAS G12C-mutated non-small cell lung cancer (NSCLC) after they’ve had their first treatment. In this study, some people will get olomorasib, and others will get a placebo. Olomorasib is the investigational study drug in this study, and it is not approved by the United States Food and Drug...
A Multinational, Multicenter, Prospective, OpenLabel, Safety and DosimetryStudy of Lutetium (177Lu)Rosopatamab Tetraxetan in Combination withStandard of Care in Patients with Prostate-SpecificMembrane Antigen (PSMA) Positive MetastaticCastration-Resistant

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 Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator- Controlled Clinical study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05933577

Population:

Adult

Phase:

III

The purpose of this study is to compare V940 plus pembro given after surgery to a placebo plus pembro given after surgery and to study how effective the study drug is. A placebo looks like a study drug, but it has no active ingredients. V940 has not yet been approved by the Food and Drug Administration (FDA). Pembrolizumab is FDA approved but it has not been approved for use with V940. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Cannot have ocular and/or mucosal melanoma - No COVID-19 and seasonal flu vaccines within 30 days before the first dose of the study drug
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

Principal Investigator:

Brian Peter Marr, MD

Contact Number:

212-342-5162

NCT Number:

NCT06007690

Population:

Adult

Phase:

III

The purpose of this study is to test and determine how safe and how well bel-sar treatment works compared to sham (no medication or laser) in participants who have a type of eye cancer called an indeterminate lesion (a growth in your eye that is suspected to be melanoma) or choroidal melanoma, also known as eye melanoma. We hope that Bel-sar can selectively target and destroy the tumor cells in the eye, while not affecting the normal cells. Bel-sar has not been approved by Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) must be 18 years old or older - must not have...
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-...
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...
Melanoma Margins Trial (MelMarT): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

Principal Investigator:

Bret Taback, MD

Contact Number:

212-342-5162

NCT Number:

NCT03860883

Population:

Adult

Phase:

III

During surgery for melanoma, the skin cancer and a small margin of healthy tissue around it are removed. This study will investigate how much skin should be removed from around the melanoma. Currently, doctors do not know how much skin to remove from around a melanoma to reduce the chances of the melanoma coming back. This study is being done to answer the following questions: Is a 1-centimeter margin as good as a 2-centimeter margin at reducing the risk of melanoma returning? Does having less than a 2-centimeter margin of skin removed cause fewer side effects and improve quality of life?...
NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGHRISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FORLOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENTTHERAPY FOR HIGHER GENOMIC RISK WITH RADIATION(PREDICT-RT*)

Principal Investigator:

Israel Deutsch, MD

Contact Number:

212-342-5162

NCT Number:

NCT04513717

Population:

Adult

Phase:

III

This study is being done in subjects that have high-risk prostate cancer, a low gene risk score and with a plan to receive radiation therapy to find out if: - A shorter hormone therapy treatment is as effective at controlling the prostate cancer compared to the usual 24-month hormone therapy treatment, or - If adding a new hormone therapy drug to the usual treatment increase the length of time without prostate cancer spreading as compared to the usual treatment. Depending on the group you are randomized to you could receive FDA-approved hormone therapy that you and your study doctor will...
OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

Principal Investigator:

Meghna S Trivedi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05812807

Population:

Adult

Phase:

III

This study is being done to answer the following question: Among patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) after preoperative chemotherapy in combination with pembrolizumab, will observation after surgery be as effective as completing 6 more months of pembrolizumab after surgery at preventing cancer from coming back? This study aims to find out if observation is as good as the usual approach for early-stage TNBC. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab...

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