Phase 2 Ovarian Cancer Trial, Recruiting NCT04606914 Sponsor: University of Alabama at Birmingham Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT04606914
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with high-grade serous epithelial ovarian cancer, confirmed by a biopsy
  • People whose cancer is at stage III or IV and for whom doctors have determined that chemotherapy before surgery (neoadjuvant chemotherapy) is the appropriate treatment plan
  • People whose tumor tests positive for a specific protein called folate receptor alpha (FRα), found in more than 75% of tumor cells at a certain level of intensity
  • People who are able to provide a stored tumor tissue sample, or who are willing to have a new biopsy taken using a routine, low-risk procedure, so that the FRα protein level can be confirmed
  • People who have a good general level of physical functioning, rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
  • People whose blood, liver, and kidney test results fall within acceptable ranges as defined by the trial (confirm with trial site for specific values)
  • People who are willing and able to sign a consent form and follow the requirements of the trial
  • Women who could become pregnant must agree to use highly effective contraception during the trial treatment and for at least 4 months after the last dose
  • Women who could become pregnant must have a negative pregnancy test within 4 days before the first dose of the trial treatment

Who may not be able to join:

  • People who have previously received any systemic cancer treatment
  • People whose ovarian cancer is of a different type, specifically low-grade serous, endometrioid, clear cell, or mucinous
  • People with active or long-term eye conditions, a history of corneal transplant, or ongoing eye conditions such as uncontrolled glaucoma, certain forms of macular degeneration, active diabetic eye disease, swelling of the optic nerve, or vision in only one eye
  • People with a history of hepatitis B or hepatitis C infection, regardless of whether they are currently on antiviral treatment
  • People with a history of HIV infection
  • People who have required intravenous (IV) antibiotics for an active infection within the 2 weeks before the first treatment dose
  • People with a history of multiple sclerosis or other diseases that affect the protective coating of nerves, or a condition called Lambert-Eaton syndrome
  • People with significant heart conditions, including a heart attack within the past 6 months, unstable chest pain (angina), poorly controlled heart failure, high-grade uncontrolled high blood pressure, or uncontrolled irregular heart rhythms
  • People who have had a stroke (either bleeding or blockage type) within the 6 months before enrolling
  • People with a history of significant liver scarring (cirrhosis) classified as Child-Pugh Class B or C
  • People with a history of non-infectious lung inflammation, including a condition called noninfectious interstitial lung disease or pneumonitis
  • People who need to take folate (folic acid) supplements, for example due to folate deficiency
  • People who have had a severe allergic reaction to monoclonal antibody treatments in the past
  • Women who are pregnant or breastfeeding
  • People who have previously been treated with the trial drug (MIRV) or any other treatment that targets the FRα protein
  • People whose cancer has spread to the brain or nervous system and is either untreated or causing symptoms
  • People who have had another cancer diagnosed within the past 3 years — though people with certain very low-risk skin cancers or early-stage cancers that have been adequately treated may still be considered eligible (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Rebecca Arend, M.D., University of Alabama at Birmingham

Phone: 205-934-4986

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
27 May 2021
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

progression free survival (PFS); Objective response rate (ORR); Radiographic tumor assessment per RECIST v1.1 criteria

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov