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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...
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?...
MajesTEC-9: A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT05572515

Population:

Adult

Phase:

III

The purpose of this study is to see how teclistamab by itself compares to study treatment combinations that are commonly used to treat multiple myeloma. These study treatment combinations are either pomalidomide, bortezomib and dexamethasone, called PVd, or carfilzomib and dexamethasone, called Kd. The patients will be randomly assigned to on of the study groups. The term randomized means something is done by chance or without any particular pattern, like flipping a coin to decide an outcome. Are you Eligible? (Inclusion Criteria) Are you at least 18 years of age or older? - Do you have a...
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...
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05580562

Population:

Adult

Phase:

III

The purpose of this study is to see if ONC201 is effective in treating participants with glioma when given following radiation therapy, how safe and tolerable ONC201 as compared to using placebo (a capsule that looks like ONC201 but does not contain any active drug), and to see how well ONC201 can improve quality of life and brain functioning in patients with glioma. ONC201 is a new drug that is being developed for treating people with glioma. ONC201 may help to remove tumor cells without affecting normal cells of the body. ONC201 is a first-in-class drug, which means it is a new drug having...
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...
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

Principal Investigator:

Katherine D Crew, MD

Contact Number:

212-342-5162

NCT Number:

NCT03418961

Population:

Adult

Phase:

III

To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy. Are you Eligible? (Inclusion Criteria) Patients must have metastatic breast cancer. There is no limit for number of doses of HER-2 targeted therapy prior to registration. Patients must be at increased risk for cardiotoxicity. Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration,...
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

Principal Investigator:

Israel Deutsch, MD

Contact Number:

212-342-5162

NCT Number:

NCT05050084

Population:

Adult

Phase:

III

This study is being done to answer the following questions: If a patient has unfavorable intermediate risk prostate cancer, a low gene risk score and plans to receive radiation therapy with hormone therapy, is radiation therapy alone as effective at controlling the cancer compared to the usual combination of radiation and hormone therapy? If a patient has unfavorable intermediate risk prostate cancer, a higher gene risk score and plans to receive radiation therapy with hormone therapy, does adding another new hormone therapy drug to the usual combination of radiation and hormone therapy...

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