Recruiting
Phase 2

Sacituzumab Govitecan & Bevacizumab

Sponsor:

National Cancer Institute (NCI)

Code:

NCT07504588

Conditions

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma

Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma

Recurrent Platinum-Sensitive Ovarian High Grade Endometrioid Adenocarcinoma

Recurrent Platinum-Sensitive Ovarian High Grade Serous Adenocarcinoma

Recurrent Platinum-Sensitive Primary Peritoneal Endometrioid Adenocarcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anti-VEGF Monoclonal Antibody

Bevacizumab

Biospecimen Collection

Carboplatin

Computed Tomography

Study Details

Brief summary:

This phase II trial compares the effect of sacituzumab govitecan and bevacizumab to standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with ovarian cancer that has come back after an initial response to platinum therapy (platinum-sensitive), that has progressed after poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor maintenance therapy (recurrent), and that has a mutation in the BRCA1 or BRCA2 genes or is homologous recombination deficient. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving sacituzumab govitecan and bevacizumab may kill more tumor cells than standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with recurrent platinum-sensitive ovarian cancers that have BRCA1/2 mutations or homologous recombination deficiency.

Conditions

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma

Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma

Recurrent Platinum-Sensitive Ovarian High Grade Endometrioid Adenocarcinoma

Recurrent Platinum-Sensitive Ovarian High Grade Serous Adenocarcinoma

Recurrent Platinum-Sensitive Primary Peritoneal Endometrioid Adenocarcinoma

Study ID

NCT07504588

Start date

Sep 24, 2026

Status verified date

Sep, 2026

Completion date

Apr 12, 2029

Anticipated

Primary completion date

Apr 12, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have histologic diagnosis of high grade serous 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 non-measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1
  • 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 4 weeks 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:

  • Patients 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
  • Patients 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 registration
  • Patients who underwent major surgery must have recovered adequately from any toxicity and/or complications from surgery prior to study registration
  • 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)

Study Design

Enrollment

87 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (carboplatin, PLD, bevacizumab)

Patients receive carboplatin IV on day 1, PLD IV on day 1 (or gemcitabine IV on days 1 and 8), and bevacizumab (or anti-VEGF antibody biosimilar) IV on days 1 and 15 of each cycle. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. After 6-10 cycles, patients proceed to maintenance therapy.

MAINTENANCE: Patients receive bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients also undergo ECHO or MUGA at screening and undergo CT and/or MRI and collection of blood samples throughout the trial.

experimental: Arm II (SG, bevacizumab)

Patients receive SG IV over 1-3 hours on days 1 and 8 and bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. After 6-10 cycles, patients proceed to maintenance therapy.

MAINTENANCE: Patients receive bevacizumab (or anti-VEGF antibody biosimilar) IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients also undergo CT and/or MRI and collection of blood samples throughout the trial.

Interventions

Anti-VEGF Monoclonal Antibody

Given IV

Bevacizumab

Given IV

Biospecimen Collection

Undergo collection of blood samples

Carboplatin

Given IV

Computed Tomography

Undergo CT

Echocardiography Test

Undergo ECHO

Gemcitabine

Given IV

Magnetic Resonance Imaging

Undergo MRI

Multigated Acquisition Scan

Undergo MUGA

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

Sacituzumab Govitecan

Given IV

Primary outcome measure

  • Progression-free survival [ Time Frame: From randomization to either progressive disease or death from any cause, assessed up to 5 years ]

Central Contacts and Locations

Locations

Highlands Oncology Group - Fayetteville

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Site Public Contact

479-872-8100research@hogonc.com

Principal Investigator:

Ewa M. Matczak

Highlands Oncology Group - Rogers

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Site Public Contact

479-872-8130research@hogonc.com

Principal Investigator:

Ewa M. Matczak

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Site Public Contact

479-872-8130research@hogonc.com

Principal Investigator:

Ewa M. Matczak

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Kendrith M. Rowland

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Kendrith M. Rowland

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Kendrith M. Rowland

Carle BroMenn Medical Center

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Kendrith M. Rowland

Carle Cancer Institute Normal

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Kendrith M. Rowland

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Kendrith M. Rowland

Mercy Hospital

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-365-4673

Principal Investigator:

Deborah W. Wilbur

Oncology Associates at Mercy Medical Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-363-2690

Principal Investigator:

Deborah W. Wilbur

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-7356

Principal Investigator:

Eugenia Girda

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Grace Duininck

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Nov 5, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.