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A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT06022939

Population:

Adult

Phase:

III

This study is being done to answer the following questions: • Do people with amyloid light chain (AL) amyloidosis respond better to a consolidation treatment that uses either one high dose of the drug melphalan plus stem cell transplant or more chemotherapy alone? • Which treatment plan gives patients a better quality of life? To determine which treatment plan works better against AL amyloidosis, the study is set up to find out how good the treatments are at lowering the chance of AL amyloidosis causing problems in major organs of the body. The researchers will compare the results...
A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Principal Investigator:

Yoanna S Pumpalova, MD

Contact Number:

212-342-5162

NCT Number:

NCT06662786

Population:

Adult

Phase:

III

The purpose of this study is to compare the effects of two anticancer drugs (amivantamab and cetuximab) when each is given in combination with standard colorectal cancer (CRC) chemotherapies to participants with metastatic (cancerous) CRC that lack mutations in genes called KRAS/NRAS and BRAF. Amivantamab is an investigational drug in this study, meaning it is currently being tested and has not been approved by the United States Food and Drug Administration (FDA) for your disease. This is why amivantamab is being compared with cetuximab, an FDA-approved treatment, to evaluate its efficacy and...
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT05827016

Population:

Adult

Phase:

III

The purpose of the study is to test the safety and efficacy of iberdomide in a larger number of patients. Iberdomide is not FDA approved for the treatment of any disease. This study will also assess how patients feel about the multiple myeloma treatment received in this study, and their quality of life as it relates to their health. Iberdomide is a medication taken by mouth that binds to a protein known as cereblon, which may result in the destruction of specific proteins by the body. This study drug may modify or regulate the functioning of the immune system and may induce the destruction of...
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCoud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma

Principal Investigator:

Brian John Andrew Gill, MD

Contact Number:

212-342-5162

NCT Number:

NCT05902169

Population:

Adult

Phase:

III

The purpose of this study is to see if the implantable device, Sonocloud 9, is effective getting chemotherapy to better reach your tumor compared to receiving standard of care chemotherapy [Temozolomide and Lomustine] and to see how safe and tolerable the device is. Sonocloud 9 works by making the blood-brain barrier (BBB) more permeable(allowing liquids or gases to go through it) so chemotherapy can better reach your tumor. The BBB is a natural sealing of the blood vessels in the brain. This study is being done in participants whose brain tumor has returned and are eligible for surgery to...
A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25

Principal Investigator:

Natalie Berger, MD

Contact Number:

212-342-5162

NCT Number:

NCT05879926

Population:

Adult

Phase:

III

This study is being done to answer the following question: Will the chance of your breast cancer returning be less if chemotherapy is added to hormonal therapy with an aromatase inhibitor and ovarian suppression? We are doing this study because we want to find out if this approach is better or worse as the other usual approach for your early-stage breast cancer that is sensitive to hormones, is HER2-negative, and is at higher risk for cancer returning. The usual approach for patients who are not in a study is treatment with surgery, radiation therapy, hormonal therapy, ovarian suppression,...
A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2– ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR THERAPY (OPERA-01)

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT06016738

Population:

Adult

Phase:

III

The purpose of this study is to learn more about the investigational study drug called OP- 1250 (palazestrant) on participants with ER+, HER2- advanced or metastatic breast cancer. OP-1250 is considered endocrine therapy (treatment that adds, blocks, or removes hormones). Estrogen is a type of hormone naturally produced by the body that helps develop and maintain female sex characteristics and the growth of bones. Estrogen can also cause certain types of breast cancer to multiply, grow, and move to different parts of the body. Estrogen works in the body by binding to proteins called estrogen...
A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT06435429

Population:

Adult

Phase:

III

The purpose of this study is to find out whether zanidatamab combined with physician’s choice of chemotherapy (one of eribulin, gemcitabine, vinorelbine, or capecitabine) is safe and improves on the clinical benefit when compared to trastuzumab in combination with physician’s choice of chemotherapy (one of eribulin, gemcitabine, vinorelbine, or capecitabine) in treating the type of breast cancer you have, HER2-positive, metastatic (spread of cancer from the place where it started to other places in the body) breast cancer that is intolerant (drug is causing excessive side effects...
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune®(TTFields, 200 kHz) Concomitant with Maintenance Temozolomide andPembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide andPlacebo for the Treatment of Newly

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT06556563

Population:

Adult

Phase:

III

The purpose of this study is to compare the effects of pembrolizumab simultaneously with the Optune device and maintenance temozolomide (TMZ) versus placebo simultaneously with Optune and maintenance TMZ for the study treatment of newly diagnosed glioblastoma multiforme (GBM). In this study, a placebo is an inactive substance that looks the same as and is given the same way as pembrolizumab. The effects of pembrolizumab are compared to the effects of the placebo. Pembrolizumab is an immunotherapy and it works with your immune system to help fight cancer. Optune® device generates Tumor...
A Phase III Multi-center, Open-label, Sponsor-blinded,Randomized Study of AZD0901 Monotherapy Compared withInvestigator’s Choice of Therapy in Second- or Later-Line AdultParticipants with Advanced/Metastatic Gastric orGastroesophageal 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...
A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib +Fulvestrant as Treatment for PIK3CA-mutant Hormone ReceptorPositive, Human Epidermal Growth Factor Receptor 2 Negative(HR+/HER2-)

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT06982521

Population:

Adult

Phase:

III

This study is being done to see how well a new, experimental drug called RLY-2608, when used together with another drug called fulvestrant, works compared to a currently approved treatment (capivasertib + fulvestrant) for a specific type of breast cancer. It’s for people who have hormone receptor-positive, HER2-negative breast cancer that has either spread in the body (metastatic) or grown into nearby tissues (locally advanced), and who also have a change (mutation) in a gene called PIK3CA. Are you Eligible? (Inclusion Criteria) ≥18 years of age. 2.Women in the study can be...

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