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New hope for ovarian cancer: targeted drug combo takes on resistant tumors

NCT ID NCT07504588

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This phase II trial compares a new two-drug combination (sacituzumab govitecan plus bevacizumab) against standard chemotherapy (carboplatin, liposomal doxorubicin, and bevacizumab) in 87 women with platinum-sensitive ovarian cancer that has progressed after PARP inhibitor maintenance. The new combo uses a targeted antibody to deliver chemotherapy directly to cancer cells, while bevacizumab blocks blood vessel growth. The goal is to see if this approach can delay cancer progression better than current standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacituzumab govitecan and bevacizumab
What this could lead to
If it works, this could offer a new treatment option for women with ovarian cancer that has returned after initial therapy and PARP inhibitor maintenance.
What could go wrong
This is a small, early-phase trial (87 participants) and may not show a clear benefit over standard care. Side effects from the drugs can be serious, including low blood counts, fatigue, and bleeding risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 87 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have histologic diagnosis of high grade serious or endometrioid epithelial ovarian cancer * Ovarian cancer = fallopian tube, ovarian, and primary peritoneal cancer * Disease must be platinum sensitive, as defined by progression documented ≥ 6 months (182 days) from the last receipt of platinum * Disease must have progressed during first line maintenance PARP inhibitor (PARPi) for advanced ovarian cancer. NO intervening therapies between progression on PARPi and study registration are permitted * Disease must be germline or somatic BRCA1 or BRCA2 mutated or homologous recombination deficiency test positive * Disease must be measurable or assessable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 * Patients with treated brain metastases are eligible if follow up brain imaging 4 weeks after central nervous system (CNS) directed therapy shows no evidence of progression * Secondary or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted * No previous receipt of any topoisomerase-I inhibiting agents * No investigational agents within 4 weeks of study registration * No current treatment with any other (non-study) cytotoxic chemotherapy, targeted therapy, biologic therapy, immunotherapy or endocrine therapy for the treatment of the disease under the current study * Last dose of PARP inhibitor treatment must be ≥ 3 weeks before study registration * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids * Age ≥ 18 * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Not pregnant and not nursing * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 9 g/dl is acceptable) * Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula * Urinalysis with ≤ 1+ protein and/or urine protein \< 1.0 g/24 hours (hrs) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better * No active infection requiring parenteral antibiotics * No non-healing wound, ulcer, or bone fracture * No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube * No clinically significant bleeding within 28 days prior to registration * No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the following exceptions: * Participants with grade 2 or lower neuropathy, any grade alopecia, well controlled hypertension, thyroid disease controlled with therapy, and history of thromboembolic disease on anticoagulation are eligible * Participants with laboratory-based grade 2 or higher adverse events (AEs) that meet the criteria outlined above are eligible * No major surgery within 3 weeks prior to study entry * Patients who underwent major surgery must have recovered adequately from any toxicity and/or complications from surgery prior to starting therapy * No strong inhibitors or inducers of UGT1A1 * No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.