Recurrent Platinum-Sensitive Fallopian Tube Endometrioid AdenocarcinomaPhase 2NCT07504588
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
A Phase 2 study testing Anti-VEGF Monoclonal Antibody, Bevacizumab and Biospecimen Collection in people with Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma and Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma, run by National Cancer Institute (NCI) at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma, Recurrent Platinum-Sensitive Ovarian High Grade Endometrioid Adenocarcinoma
- What is being tested?
- Anti-VEGF Monoclonal Antibody, Bevacizumab and Biospecimen Collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 13 sitesUnited States
- Study dates
- 24 Sep 2026to 12 Apr 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 35Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703
Site Public Contact, 479-872-8100, research@hogonc.com
Ewa M. Matczak
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758
Site Public Contact, 479-872-8130, research@hogonc.com
Ewa M. Matczak
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
Site Public Contact, 479-872-8130, research@hogonc.com
Ewa M. Matczak
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
About this study
Official title: A Randomized Phase II Trial of Sacituzumab Govitecan-HZIY (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients With Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the clinical activity of sacituzumab govitecan (sacituzumab govitecan-hziy [SG]) and bevacizumab (or an anti-VEGF antibody biosimilar) compared to standard of care carboplatin, pegylated liposomal doxorubicin hydrochloride (pegylated liposomal doxorubicin [PLD]) and bevacizumab (or an anti-VEGF antibody biosimilar), as measured by progression-free survival, in patients with platinum-sensitive ovarian cancer that has progressed while receiving first-line PARP inhibitor maintenance therapy.
SECONDARY OBJECTIVES:
- To assess additional measures of clinical activity of SG and bevacizumab compared to standard of care carboplatin, PLD and bevacizumab in patients with recurrent platinum-sensitive ovarian cancer, as measured by the overall response rate, duration of response, and overall survival.
II. To assess the safety of SG and bevacizumab in patients with recurrent platinum-sensitive ovarian cancer.
III. To assess the effect of SG and bevacizumab on overall survival in recurrent platinum-sensitive ovarian cancer.
EXPLORATORY OBJECTIVES:
- To correlate clinical activity of SG and bevacizumab with TROP2 expression and tumor-specific cell-free deoxyribonucleic acid (cfDNA).
II. To assess time to first subsequent therapy or death (TFST). III. To assess time to second subsequent therapy or death (TSST).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive carboplatin intravenously (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.
ARM II: 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 in Arm I also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening and all patients undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
- 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, Recurrent Platinum-Sensitive Primary Peritoneal High Grade Serous Adenocarcinoma
- Being tested
- Anti-VEGF Monoclonal Antibody, Bevacizumab, Biospecimen Collection, Carboplatin, Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-VEGF Monoclonal AntibodyBiological
Also called MoAb VEGF, Monoclonal Antibody Anti-VEGF
Given IV
BevacizumabBiological
Also called ABP 215, ABP-215, ABP215, Alymsys
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
GemcitabineDrug
Also called dFdC, dFdCyd, Difluorodeoxycytidine
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA
Pegylated Liposomal Doxorubicin HydrochlorideDrug
Also called ATI-0918, Caelyx, Dox-SL, Doxil
Given IV
Sacituzumab GovitecanBiological
Also called hRS7-SN38 Antibody Drug Conjugate, IMMU 132, IMMU-132, IMMU132
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (carboplatin, PLD, bevacizumab) | Active comparator | 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. Receives: Biological: Anti-VEGF Monoclonal Antibody; Biological: Bevacizumab; Procedure: Biospecimen Collection; Drug: Carboplatin; Procedure: Computed Tomography; Procedure: Echocardiography Test; Drug: Gemcitabine; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Pegylated Liposomal Doxorubicin Hydrochloride |
| Arm II (SG, bevacizumab) | Experimental | 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. Receives: Biological: Anti-VEGF Monoclonal Antibody; Biological: Bevacizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Sacituzumab Govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The primary analysis will compare progression-free survival between Arm II and Arm I using a stratified log-rank test. The corresponding hazard ratio will be estimated from a stratified Cox regression model. The treatment hazard ratio estimate and its 95% confidence interval will be estimated using proportional hazards models specified to be consistent with the logrank tests.
Measured: From randomization to either progressive disease or death from any cause, assessed up to 5 years
Secondary outcomes (4)
Objective response rate (ORR)
The ORR is the percentage of evaluable patients who achieve a complete response (CR) or partial response (PR) within 12 months of starting maintenance therapy. The analysis will be based on physician-assessed responses according to Response Evaluation Criteria in Solid Tumors 1.1 criteria. Comparisons of ORR between the experimental and reference groups will use a multivariable logistic regression model, stratified by the randomization factors, to estimate the odds ratio. A 95% Jeffries confidence interval will also be calculated for the ORR in each treatment arm.
Measured: Within 12 months of starting maintenance therapy
Duration of response (DOR)
DOR will be visualized using Kaplan-Meier curves, and the treatment groups will be compared with a stratified log-rank test. A stratified Cox proportional hazards model will be used to estimate the hazard ratio for progression or death between the groups.
Measured: From the first documented response (CR or PR) until disease progression or death, assessed up to 5 years
Incidence of adverse events
The nature, frequency, and degree of toxicity will be tabulated at the System Organ Class and adverse event-specific term levels using Common Terminology Criteria for Adverse Events version 5.0. Each patient will be represented according to the maximum grade observed for each term. Tabulations will show the number and percentage of patients by maximum grade, within the treatment group received, regardless of the randomized treatment assignment.
Measured: Up to 5 years
Overall survival
Estimates of treatment effect will be interpreted descriptively with associated confidence intervals, without formal hypothesis testing.
Measured: From randomization to death from any cause, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start24 Sep 2026
- Primary completion12 Apr 2029 (estimated)
- Study completion12 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Platinum-Sensitive Fallopian Tube Endometrioid AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rebecca L Porter, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504588
- Sponsor's protocol ID
- NCI-2026-01998
- Other IDs
- NCI-2026-01998, NRG-GY038, NRG-GY038, U10CA180868
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.