Is NCT04606914 recruiting in Minneapolis, MN?

Yes, NCT04606914 is currently recruiting participants at its Minneapolis, MN location. This ovarian cancer clinical trial is actively enrolling qualified participants.

How do I join the ovarian cancer clinical trial in Minneapolis?

To join this clinical trial in Minneapolis, 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 Minneapolis 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 Minneapolis, MN

About This Ovarian Cancer Study in Minneapolis

The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eli

Sponsor: University of Alabama at Birmingham

Who Can Participate

Inclusion Criteria

Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.

Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy

Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity

Patients must have a performance status of 0 or 1.

Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in \>75% of cells

Patients must have adequate hematologic, liver and kidney functions defined as:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL)

Platelet count ≥ 100 x 109/L (100,000/μL) without platelet transfusion in the prior 10 days

Hemoglobin ≥ 9.0 g/dL

Serum creatinine ≤ 1.5 x upper limit of normal (ULN)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN

Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN)

Serum albumin ≥ 2 g/dL

Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements

Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.8.6 while on MIRV and for at least 4 months after the last dose

WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV

Exclusion Criteria

Patients who have previously been treated with a systemic anti-cancer therapy

Patients with low-grade serous, endometrioid, clear cell, or mucinous histology

Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision

Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:

History of hepatitis B or C infection (whether or not on active antiviral therapy)

History of human immunodeficiency virus (HIV) infection

Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV

Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)

Patients with clinically significant cardiac disease including, but not limited to, any of the following:

Myocardial infarction ≤ 6 months prior to first dose

Unstable angina pectoris

Uncontrolled congestive heart failure (New York Heart Association \> class II)

Uncontrolled ≥ Grade 3 hypertension (per CTCAE)

Uncontrolled cardiac arrhythmias

Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment

Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)

Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis

Patients requiring use of folate-containing supplements (eg, folate deficiency)

Patients with prior hypersensitivity to monoclonal antibodies (mAb)

Women who are pregnant or breastfeeding

Patients who received prior treatment with MIRV or other FRα-targeting agents

Patients with untreated or symptomatic central nervous system (CNS) metastases

Patients with a history of other malignancy within 3 years prior to enrollment Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible

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 Minneapolis?

Yes, this clinical trial (NCT04606914) has an active research site in Minneapolis, MN 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 Minneapolis, MN

If you're searching for ovarian cancer treatment options in Minneapolis, MN, this clinical trial (NCT04606914) 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 Minneapolis research site is actively enrolling participants for this phase 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 Minneapolis, MN

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