87 Participants NeededMy employer runs this trial

Sacituzumab Govitecan + Bevacizumab for Ovarian Cancer

Recruiting at 21 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for ovarian cancer that has returned after initial treatment and exhibits specific genetic markers (BRCA1/2 mutations or homologous recombination deficiency). The study compares two treatments: a combination of sacituzumab govitecan, a targeted therapy that delivers cancer-killing drugs directly to cancer cells, and bevacizumab, which prevents tumor growth by cutting off its blood supply, against the current standard treatment. The researchers aim to determine if the new combination can kill more cancer cells than the usual treatment. This trial may suit those with ovarian cancer that responded to platinum therapy but progressed after PARP inhibitor maintenance and have the specified genetic profile. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop any current treatment with cytotoxic chemotherapy, targeted therapy, biologic therapy, immunotherapy, or endocrine therapy for your ovarian cancer. Additionally, you must not have taken any investigational agents within 4 weeks before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies found that sacituzumab govitecan was generally well-tolerated by patients. Common side effects included low levels of a type of white blood cell, nausea, diarrhea, and tiredness, occurring in more than 60% of patients. Despite these side effects, many patients continued treatment, suggesting they may be manageable.

Bevacizumab, another treatment in this trial, is already approved for other types of cancer, so its safety is well-known. Typical side effects include high blood pressure and bleeding, which can be managed with medical care.

Overall, both treatments have been tested in humans before and have shown a tolerable safety profile. However, side effects can occur, and discussing these with the trial team is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Sacituzumab Govitecan for ovarian cancer because it introduces a novel approach by combining a targeted antibody with a cancer-killing drug. Unlike traditional chemotherapy, which affects both cancerous and healthy cells, Sacituzumab Govitecan specifically targets cancer cells by attaching to a protein called Trop-2, which is often overexpressed in ovarian cancer cells. This targeted mechanism could potentially lead to fewer side effects and more effective tumor reduction. Additionally, combining it with Bevacizumab, an anti-VEGF therapy, may enhance its effectiveness by inhibiting blood supply to the tumor, making it a promising option for patients who haven't responded to standard treatments.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

This trial will compare two treatment regimens for ovarian cancer. In one arm, patients will receive a combination of carboplatin, pegylated liposomal doxorubicin hydrochloride (PLD), and bevacizumab. Studies have shown that adding bevacizumab to chemotherapy can extend the time patients with ovarian cancer live without disease progression. Specifically, one study found that patients receiving bevacizumab with chemotherapy had a median progression-free survival of 6.7 months, compared to 3 months for those receiving only chemotherapy.

In the other arm of this trial, patients will receive sacituzumab govitecan combined with bevacizumab. Sacituzumab govitecan, another treatment for ovarian cancer, has shown mixed results. Some patients who haven't responded to other treatments might benefit from sacituzumab govitecan, but further research is needed. Combining sacituzumab govitecan with bevacizumab might kill more cancer cells than standard treatments, offering hope for better outcomes in ovarian cancer care.678910

Who Is on the Research Team?

RL

Rebecca L Porter

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for adults with high-grade ovarian, fallopian tube, or primary peritoneal cancer that has come back after responding to platinum chemo and progressed during PARP inhibitor maintenance. Their cancer must have BRCA1/2 mutations or be homologous recombination deficient. Disease must be measurable, and certain prior treatments are not allowed.

Inclusion Criteria

I have not had surgery to remove tumors after starting this trial treatment.
I have never received topoisomerase-I inhibitor drugs.
I have been diagnosed with high grade serous or endometrioid ovarian cancer.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Patients receive either sacituzumab govitecan and bevacizumab or standard care (carboplatin, PLD, and bevacizumab) for 6-10 cycles

18-30 weeks
Every 21 days per cycle

Maintenance

Patients receive bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle

Until disease progression or unacceptable toxicity
Every 21 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 3 months for 2 years, then every 6 months for 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Carboplatin
  • Pegylated Liposomal Doxorubicin Hydrochloride
  • Sacituzumab Govitecan

Trial Overview

The study compares a new combo of sacituzumab govitecan plus bevacizumab against standard treatment (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in people with recurrent platinum-sensitive ovarian cancer after PARP inhibitor therapy. Patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (SG, bevacizumab)Experimental Treatment6 Interventions
Group II: Arm I (carboplatin, PLD, bevacizumab)Active Control10 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Platinum-Resistant Ovarian Cancer: Bevacizumab ...

In the overall trial, the median PFS was 6.7 months for bevacizumab plus chemotherapy versus 3 months for chemotherapy alone. Investigators could choose ...

Bevacizumab in combination with metronomic oral ...

A response was demonstrated in 37 (62.7%) patients, with a median progression free survival of 6 months (range 0-44). No toxicity was recorded in the medical ...

Bevacizumab in the Treatment of Advanced Ovarian Cancer

These trials demonstrate a modest progression-free survival advantage in patients treated with bevacizumab concurrently with standard ...

Sacituzumab Govitecan for Ovarian Cancer

Some studies indicate it might be an option for patients who haven't had success with other chemotherapy treatments. However, the results are mixed. In one ...

Bevacizumab Benefit Varies Among Ovarian Cancer ...

Bevacizumab was associated with a nonsignificant improvement in PFS of 8.2 months (HR, 0.78; 95% CI, 0.44-1.40; P = .41) in patients with ...

Sacituzumab Tirumotecan Across Gynecologic Malignancies

This review aims to highlight the therapeutic potential of Sacituzumab Govitecan in gynecologic malignancies and to summarize the most recent ...

Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate ...

Sacituzumab govitecan was well tolerated and induced early and durable responses in heavily pretreated patients with metastatic TNBC. As a therapeutic target ...

Sacituzumab Govitecan Shows Promise in Advanced ...

The median duration of response was 8.8 months, and median progression-free survival was 4.8 months. For 39 patients, a Trop-2 exploratory ...

Effectiveness, safety, and biomarker analysis of ...

Sacituzumab govitecan (SG) is a newer type of targeted therapy for advanced triple-negative breast cancer (TNBC) and hormone receptor-positive/HER2-negative ( ...

20 Final Overall Survival (OS) Analysis From the Phase 3 ...

At data cutoff (December 1, 2022), 437 OS events had occurred, with 47 (8.7%) new deaths in the sacituzumab govitecan vs TPC groups (22 [8.1%] ...