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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 Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT06973187

Population:

Adult

Phase:

III

Chronic lymphocytic leukemia (CLL) is the most common adult leukemia. Although newer treatments have helped many patients, some people experience relapsed disease, meaning the cancer returns after treatment, or refractory disease, meaning the cancer does not respond to treatment. Small lymphocytic lymphoma (SLL) is a similar disease to CLL, but appears mainly in the lymph nodes rather than the blood. BGB-16673 is an investigational drug, meaning it is not approved by the United States Food and Drug Administration (FDA). It is described as selective, meaning it is designed to act mainly on one...
AGCT1532: Phase 3 Accelerated BEP Trial:A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT02582697

Population:

Pediatrics/Adult

Phase:

III

This is a study for patients between 11 years and 45 years who have newly diagnosed intermediate or poor-risk metastatic germ cell tumors (GCTs). This study is looking at whether giving treatment with Bleomycin, Etoposide, and Cisplatin (BEP)every 2 weeks (accelerated BEP) or every 3 weeks (standard BEP) is better. Participants will be randomized to either Arm A: standard BEP or Arm B: accelerated BEP. All participants will receive a medication to stimulate the body to make white blood cells which has allowed some chemotherapy regimens to be given with a shorter than usual cycle length, while...
A Phase IIb, Randomized, Multicenter, Open-label Study toassess the Efficacy of Durvalumab plus Tremelimumab versusPembrolizumab in Combination with Platinum-BasedChemotherapy for First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06008093

Population:

Adult

Phase:

III

The purpose this study to learn more about if a medication called durvalumab will work and be safe for the treatment of non small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) with certain genetic changes when given in combination with tremelimumab and standard chemotherapy. Additionally, this study is being done to better understand metastatic NSCLC and associated health problems. Durvalumab and tremelimumab are types of anti-cancer drugs called immunotherapy that target cancer cells by blocking the signal that prevents the immune system from seeing the...
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...
LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients with Molecular Low-Risk Early-Stage Breast Cancer

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT06671912

Population:

Adult

Phase:

III

This study is being done to answer the following question: Is treatment with a lower dose of tamoxifen, a form of hormonal therapy, as good as the usual hormonal therapy in women with low-risk, early-stage breast cancer? The usual approach for patients who are not in a study is treatment with hormonal therapy. Hormonal therapy can be an aromatase inhibitor (such as letrozole, anastrozole, or exemestane) or tamoxifen at a dose of 20mg/day. Your doctor can explain which treatment may be best for you. For patients who get the usual approach for this cancer, about 96 out of 100 are free of cancer...
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...
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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