CClinicalTrials.gg
RecruitingNCT07504588Updated Oct 5, 2026

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 interventional study of Anti-VEGF Monoclonal Antibody and Bevacizumab in Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma and Recurrent Platinum-Sensitive Ovarian High Grade Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI). Recruiting at 9 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Updated Oct 5, 2026Start date moved8 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVE:

I. 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:

I. 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:

I. 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
87 participants (estimated)

Study 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.

    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

  • 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.

    Biological: Anti-VEGF Monoclonal Antibody · Biological: Bevacizumab · Procedure: Biospecimen Collection · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Biological: Sacituzumab Govitecan

Interventions

  • BiologicalAnti-VEGF Monoclonal Antibody

    Given IV

    Also known as: MoAb VEGF, Monoclonal Antibody Anti-VEGF

  • BiologicalBevacizumab

    Given IV

    Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avegra, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-aveg, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-byva, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-nwgd, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, Byvasda, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, IBI 305, IBI-305, IBI305, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Jobevne, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • DrugCarboplatin

    Given IV

    Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

  • ProcedureComputed Tomography

    Undergo CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • ProcedureEchocardiography Test

    Undergo ECHO

    Also known as: EC, Echocardiography

  • DrugGemcitabine

    Given IV

    Also known as: dFdC, dFdCyd, Difluorodeoxycytidine

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • ProcedureMultigated Acquisition Scan

    Undergo MUGA

    Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

  • DrugPegylated Liposomal Doxorubicin Hydrochloride

    Given IV

    Also known as: ATI-0918, Caelyx, Dox-SL, Doxil, Doxilen, Doxorubicin HCl Liposomal, Doxorubicin HCl Liposome, Doxorubicin Hydrochloride Liposome, Doxorubicin Liposomal, Duomeisu, Evacet, LipoDox, Lipodox 50, Liposomal Adriamycin, Liposomal Doxorubicin Hydrochloride, Liposomal-Encapsulated Doxorubicin, Pegylated Doxorubicin HCl Liposome, Pegylated Liposomal Doxorubicin, S-Liposomal Doxorubicin, Stealth Liposomal Doxorubicin, TLC D-99

  • BiologicalSacituzumab Govitecan

    Given IV

    Also known as: hRS7-SN38 Antibody Drug Conjugate, IMMU 132, IMMU-132, IMMU132, RS7 SN38, RS7-SN38, RS7SN38, Sacituzumab Govitecan-hziy, Trodelvy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From randomization to either progressive disease or death from any cause, assessed up to 5 years

Secondary outcomes

  1. 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.

    Time frame: Within 12 months of starting maintenance therapy

  2. 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.

    Time frame: From the first documented response (CR or PR) until disease progression or death, assessed up to 5 years

  3. 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.

    Time frame: Up to 5 years

  4. Overall survival

    Estimates of treatment effect will be interpreted descriptively with associated confidence intervals, without formal hypothesis testing.

    Time frame: From randomization to death from any cause, assessed up to 5 years

Other outcomes

  1. TROP2 expression

    TROP2 expression will be correlated with clinical activity of sacituzumab govitecan (SG) and bevacizumab to assess how the clinical effect of the randomized treatment is modified by TROP2 expression. Will formally test the interaction between the biomarker and the treatment assignment to assess whether this is a predictive biomarker. A logistic regression model will be used to test the treatment-by-TROP2 interaction on the odds of achieving a response. The odds ratio for the treatment effect will be estimated within each TROP2 subgroup. A Cox proportional hazards model will be fitted with main effects for treatment, TROP2 status, and a treatment-by-TROP2 interaction term. A statistically significant interaction term would suggest TROP2 is a predictive biomarker. The treatment effect will be estimated and displayed on a forest plot for TROP2-high and TROP2-low subgroups. Kaplan-Meier curves for PFS will be plotted for each treatment arm within each TROP2 subgroup.

    Time frame: Up to 5 years

  2. Cell-free deoxyribonucleic acid (cfDNA)

    cfDNA expression will be correlated with clinical activity of SG and bevacizumab to assess how the clinical effect of the randomized treatment is modified by cfDNA expression. Will formally test the interaction between the biomarker and the treatment assignment to assess whether this is a predictive biomarker.

    Time frame: Up to 5 years

  3. Time to first subsequent therapy or death (TFST)

    TFST distributions by randomized treatment assignment in the intent to treat population will be visualized using Kaplan-Meier curves. The effect of treatment assignment on TFST will be estimated using a Cox proportional hazards model, stratified by the randomization factors. Hazard ratio estimates and 95% confidence intervals will be reported to quantify the treatment effect. Treatment effects within strata will be presented in a forest plot.

    Time frame: From randomization to the earliest occurrence of either first subsequent therapy or death, assessed up to 5 years

  4. Time to second subsequent therapy or death (TSST)

    TSST distributions by randomized treatment assignment in the intent to treat population will be visualized using Kaplan-Meier curves. The effect of treatment assignment on TSST will be estimated using a Cox proportional hazards model, stratified by the randomization factors. Hazard ratio estimates and 95% confidence intervals will be reported to quantify the treatment effect. Treatment effects within strata will be presented in a forest plot.

    Time frame: From randomization to the earliest occurrence of either second subsequent therapy or death, assessed up to 5 years

07

Study locations

9 of 9 sites recruiting
  • Highlands Oncology Group - Fayetteville
    Fayetteville, Arkansas 72703, United States
    • Site Public Contact · Contact · research@hogonc.com · 479-872-8100
    • Ewa M. Matczak · Principal investigator
    Recruiting
  • Highlands Oncology Group - Rogers
    Rogers, Arkansas 72758, United States
    • Site Public Contact · Contact · research@hogonc.com · 479-872-8130
    • Ewa M. Matczak · Principal investigator
    Recruiting
  • Highlands Oncology Group
    Springdale, Arkansas 72762, United States
    • Site Public Contact · Contact · research@hogonc.com · 479-872-8130
    • Ewa M. Matczak · Principal investigator
    Recruiting
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho 83854, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho 83864, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Mercy Hospital Springfield
    Springfield, Missouri 65804, United States
    • Site Public Contact · Contact · 417-269-4520
    • Jay W. Carlson · Principal investigator
    Recruiting
  • Billings Clinic Cancer Center
    Billings, Montana 59101, United States
    Recruiting
  • Community Medical Center
    Missoula, Montana 59804, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

3 registry updates since Sep 25, 2026
Sites
8 sites added
Show 8 added (8 United States)
  • Kootenai Health - Coeur d'Alene · Coeur d'Alene, United States
  • Kootenai Clinic Cancer Services - Post Falls · Post Falls, United States
  • Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, United States
  • Highlands Oncology Group - Fayetteville · Fayetteville, United States
  • Highlands Oncology Group - Rogers · Rogers, United States
  • Highlands Oncology Group · Springdale, United States
  • Billings Clinic Cancer Center · Billings, United States
  • Community Medical Center · Missoula, United States
across 3 updates, Sep 28, 2026 – Oct 5, 2026
Start date
Jun 1, 2027→Sep 24, 2026 (actual)
Sep 29, 2026
Show all 3 updates
  1. Oct 5, 2026
    2 sites added
    Show 2 added (2 United States)
    • Billings Clinic Cancer Center · Billings, United States
    • Community Medical Center · Missoula, United States
  2. Sep 29, 2026
    3 sites added
    Show 3 added (3 United States)
    • Highlands Oncology Group - Fayetteville · Fayetteville, United States
    • Highlands Oncology Group - Rogers · Rogers, United States
    • Highlands Oncology Group · Springdale, United States
    Start date Jun 1, 2027→Sep 24, 2026 (now actual)
  3. Sep 28, 2026
    3 sites added
    Show 3 added (3 United States)
    • Kootenai Health - Coeur d'Alene · Coeur d'Alene, United States
    • Kootenai Clinic Cancer Services - Post Falls · Post Falls, United States
    • Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07504588
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 1, 2026
Start date
Sep 24, 2026
Primary completion
Apr 12, 2029 (estimated)
Completion
Apr 12, 2029 (estimated)
Last update
Oct 5, 2026

Study contacts

Rebecca L Porter
principal investigator · NRG Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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