Is NCT06040970 recruiting in New York, NY?

Yes, NCT06040970 is currently recruiting participants at its New York, NY location. This ovarian cancer clinical trial is actively enrolling qualified participants.

How do I join the ovarian cancer clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Ovarian Cancer Clinical Trial in New York, NY

About This Ovarian Cancer Study in New York

This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

Exclusion Criteria

to be registered to the study. Study treatment may not begin until a subject is registered. Inclusion Criteria:

Pathologic (histology or cytology) confirmed diagnosis of epithelial ovarian cancer or endometrial cancer

Radiographic evidence of recurrent epithelial ovarian cancer (ovarian, fallopian tube, or primary peritoneal cancer) or endometrial cancer that is "platinum-sensitive," defined as progression of disease beyond 6 months from the last dose of platinum-based chemotherapy

Female, age ≥ 18 years

World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

Patient has measurable disease (at least one lesion that can be accurately assessed repeatedly by CT) as evidenced on pre-treatment baseline CT of Chest/Abdomen/Pelvis or PET/CT, or evaluable disease

Adequate hematologic counts, as defined below, without transfusion or growth factor support within 2 weeks of study drug initiation:

Hemoglobin ≥ 8.5 g/dL

Absolute neutrophil count ≥ 1500/mm3

Platelets ≥ 100,000/μL

Adequate organ function as defined below:

Total bilirubin ≤ 1.5 ULN

AST(SGOT)/ALT(SPGT) ≤ 2.5x ULN or ≤ 5 x ULN if known liver metastases

Serum albumin \> 3 g/dL

Creatinine clearance ≥ 50 mL/min per the Cockcroft-Gault equation

Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. o A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

Has not undergone a hysterectomy or bilateral oophorectomy; or

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Treatment with any of the following:

Any investigational agents or study drugs from a previous clinical study within 28 days or 5 half-lives (whichever is longer) of the first dose of study treatment

Any other chemotherapy, immunotherapy or anticancer agents within 14 days of the first dose of study treatment

Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment

Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment

With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment

As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or uncontrolled infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.

Known or severe (Grade 3 or higher) hypersensitivity to SG and/or cisplatin, their metabolites, or formulation excipients

Peripheral neuropathy grade 2 or greater

Refractory nausea and vomiting, chronic gastrointestinal diseases

Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Women of childbearing potential unwilling to use effective contraception during study until conclusion of 6-month post-treatment evaluation period

Known history of unstable angina, MI, or CHF present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy

Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months of enrollment.

Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of enrollment.

Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Prior therapy with sacituzumab govitecan, irinotecan, Trop-2-directed antibody drug conjugate, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease

Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.

Requirement for ongoing therapy with any prohibited medications

Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease for ≥ 4 weeks prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking 10 mg/day or less of prednisone or its equivalent. All participants with carcinomatous meningitis are excluded regardless of clinical stability.

Have an active second malignancy. Participants with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to randomization, or participants with surgically cured tumors with low risk of recurrence (e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.

Use of any live vaccine against infectious diseases within 30 days of the first dose of study drugs.

Have an active serious infection requiring systemic antimicrobial therapy

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06040970) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Ovarian Cancer Treatment Options in New York, NY

If you're searching for ovarian cancer treatment options in New York, NY, this clinical trial (NCT06040970) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced ovarian cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ovarian cancer clinical trials near you to find additional studies recruiting in your area.

Ovarian Cancer Clinical Trial in New York, NY

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