Breast CancerPhase 2NCT03414658
The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer
A Phase 2 study testing Vinorelbine, Trastuzumab and Avelumab in people with Breast Cancer, run by Adrienne G. Waks at 17 sites in United States.
Trial summary
This research study is studying a combination of drugs as a possible treatment for breast cancer. The drugs involved in this study are: Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine) Group B: Trastuzumab + Vinorelbine + Avelumab Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vinorelbine, Trastuzumab and Avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 17 sitesUnited States
- Study dates
- 21 Jun 2018to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years or older
- Histologically confirmed breast adenocarcinoma that is unresectable loco-regionally advanced or metastatic
- HER2-positive (immunohistochemistry score 3+) or ERBB2- amplification (Ratio ERBB2/centromeres ≥ 2.0 or mean gene copy number ≥ 6) on primary tumor or of metastatic or unresectable loco-regional biopsy.
- Measurable disease per RECIST v1.1 (see Section 11)
- Patients must have previous treatment with ado-trastuzumab emtansine (Kadcyla, T-DM1) in any setting. Patients must have previously received trastuzumab and pertuzumab in the metastatic setting or within 12 months of neoadjuvant/adjuvant treatment.
- Patient must have progressed on their most recent line of therapy. Progression must have been demonstrated by radiological or clinical assessment.
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- Left ventricular ejection fraction (LVEF) ≥ 50%
- Willingness and availability to submit FFPE tissue for central confirmation of HER2 positivity and central assessment of PD-L1 status. This can be from archival tissue from unresectable loco-regional or metastatic disease obtained ≤ 1 year prior to enrollment or new tissue material from a recently obtained surgical or diagnostic biopsy. Tissue obtained for the biopsy must not have been previously irradiated. If a patient does not have any available archival tissue ≤ 1 year old and the treating investigator does not feel that it would be safe to perform a fresh biopsy, the requirement for a fresh biopsy may be waived after discussion with the Principal Investigator.
- Written informed consent for screening and trial participation procedures including biological material transfer and handling.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Hematopoietic status:
- Absolute neutrophil count ≥ 1.0 × 109/L,
- Platelet count ≥ 100 × 109/L,
- Hemoglobin ≥ 9 g/dL
- Hepatic status:
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (< 2 × ULN) is allowed.
- AST and ALT ≤ 2.5 × ULN; if the patient has liver metastases, ALT and AST must be ≤ 5 × ULN.
- Renal status:
- Creatinine ≤ 1.5 ×ULN or creatinine clearance > 60 ml/min
- Proteinuria < 1 g/day
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulant.
- If female of childbearing potential, must have a negative pregnancy test within 7 days of initiating treatment. Childbearing potential is defined by: those who have not been surgically sterilized and/or have had a menstrual period in the past year.
- Participants of childbearing potential (as defined above) must be willing to use effective contraception during treatment and up to 7 months after stop of trial treatment. Acceptable methods of contraception are intrauterine devices, bilateral tubal occlusion, vasectomized, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.
- Must not be breastfeeding/lactating.
Who cannot join
- Prior therapy with any anti-PD-1, anti-PD-L1, L2, anti-4-1BB (CD137), or anti-CTLA4 therapy
- Known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Positive for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA [qualitative]).
- History of interstitial lung disease
- Active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically stable for at least 4 weeks before first dose of investigational product and do not require high-dose steroid treatment).
- History of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association functional classification ≥3), angina, myocardial infarction or ventricular arrhythmia.
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- Previous severe hypersensitivity reaction to treatment with another monoclonal antibody.
- Active infection requiring systemic therapy.
- Chronic systemic therapy with immunosuppressive agents including corticosteroids.
- Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the trial.
- Concurrent disease or condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient's safety.
- No uncontrolled hypertension (≥180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen.
- Chemotherapy, radiotherapy, and/or biological cancer therapy within 3 weeks prior to the first trial dose or has not recovered to CTCAE v.4 grade 1 or better from adverse events (except alopecia).
- Unresolved or unstable, serious adverse events from prior administration of another investigational drug.
- Live vaccines within 30 days prior to the first dose of trial therapy and during trial treatment.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7305
University of Chicago Medical Center
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94158
University of Washington Fred Hutchinson Cancer Care
Seattle, Washington, 98109
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination With Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients With HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzumab
This research study is studying a combination of drugs as a possible treatment for breast cancer.
The drugs involved in this study are:
- Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine)
- Group B: Trastuzumab + Vinorelbine + Avelumab
- Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease. "Investigational" means that drug combination is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved Utomilumab as a treatment for any disease.
The FDA (the U.S. Food and Drug Administration) has approved Avelumab as a treatment for other diseases.
The FDA (the U.S. Food and Drug Administration) has approved trastuzumab as a treatment option for this disease.
The FDA (the U.S. Food and Drug Administration) has approved vinorelbine as a treatment for other diseases and is commonly used as a treatment option for this disease.
The immune system is the body's natural defense against disease. The immune system sends a type of cells called T cells throughout the body to detect and fight infections and diseases-including cancers. One way the immune system controls the activity of T cells is through the PD-1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1 pathway and this stops T cells from attacking cancer cells. Avelumab is a type of drug, known as an antibody which is designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells. An antibody is a protein produced by the body's immune system when it detects harmful substances. Previous studies show that the administration of antibodies which block the PD-1 pathway can lead to tumor destruction.
Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells. Previous studies have shown that the administration of this type of antibody may help to prevent tumors from growing.
In the laboratory, adding avelumab and Utomilumab to trastuzumab appears to improve effectiveness. It is not known whether this is true in humans.
In this research study, the investigators are evaluating the activity of 3 different combinations: (a)trastuzumab and vinorelbine combined, (b) trastuzumab, vinorelbine and avelumab combined, and (c) trastuzumab, vinorelbine, avelumab and utomilumab combined in participants with metastatic HER2- positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Vinorelbine, Trastuzumab, Avelumab, Utomilumab
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
work by interfering with cell division, which leaves the tumor unable to grow and spread
TrastuzumabDrug
trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.
AvelumabDrug
monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein
UtomilumabDrug
Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
| Study group | Role | What they receive |
|---|---|---|
| NH: Trastuzumab + Vinorelbine | Experimental | * Trastuzumab is administered intravenously twice per cycle
* Vinorelbine is administered intravenously 3 times per cycle Receives: Drug: Vinorelbine; Drug: Trastuzumab |
| NHA: Trastuzumab + Vinorelbine + Avelumab | Experimental | * Trastuzumab is administered intravenously twice per cycle
* Vinorelbine is administered intravenously 3 times per cycle
* Avelumab is administered intravenously twice per cycle
* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Receives: Drug: Vinorelbine; Drug: Trastuzumab; Drug: Avelumab |
| NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab | Experimental | * Trastuzumab is administered intravenously twice per cycle
* Vinorelbine is administered intravenously 3 times per cycle
* Avelumab is administered intravenously twice per cycle
* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab
* Utomilumab is administered intravenously once per cycle Receives: Drug: Vinorelbine; Drug: Trastuzumab; Drug: Avelumab; Drug: Utomilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression Free Survival is defined from the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs first.
Measured: 2 years
Secondary outcomes (3)
Objective Response Rate
Objective Response Rate is determined by Complete Response or Partial Response by RECIST 1.1. Per RECIST 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: 2 years
Duration of Response
Duration of Response is measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Per RECIST 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Measured: 3 years
Overall Survival
Overall survival is defined as the time from randomization to death from any cause, or is censored at date last known alive.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start21 Jun 2018
- Primary completion1 May 2023
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrienne G. Waks
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Breast Cancer Research Foundation, Johns Hopkins University
- Responsible party
- Sponsor-investigator, Adrienne G. Waks, Dana-Farber Cancer Institute
- Investigators
- Adrienne Waks, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414658
- Sponsor's protocol ID
- 17-455
- Other IDs
- TBCRC045
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2017
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination With Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients With HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzumab
- ClinicalTrials.gov ID
- NCT03414658
- Acronym / sponsor ID
- 17-455
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Adrienne G. WaksUniversity, hospital or other
- Collaborators
- Pfizer, Breast Cancer Research Foundation, Johns Hopkins University
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a combination of drugs as a possible treatment for breast cancer.
The drugs involved in this study are:
- Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine)
- Group B: Trastuzumab + Vinorelbine + Avelumab
- Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease. "Investigational" means that drug combination is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved Utomilumab as a treatment for any disease.
The FDA (the U.S. Food and Drug Administration) has approved Avelumab as a treatment for other diseases.
The FDA (the U.S. Food and Drug Administration) has approved trastuzumab as a treatment option for this disease.
The FDA (the U.S. Food and Drug Administration) has approved vinorelbine as a treatment for other diseases and is commonly used as a treatment option for this disease.
The immune system is the body's natural defense against disease. The immune system sends a type of cells called T cells throughout the body to detect and fight infections and diseases-including cancers. One way the immune system controls the activity of T cells is through the PD-1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1 pathway and this stops T cells from attacking cancer cells. Avelumab is a type of drug, known as an antibody which is designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells. An antibody is a protein produced by the body's immune system when it detects harmful substances. Previous studies show that the administration of antibodies which block the PD-1 pathway can lead to tumor destruction.
Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells. Previous studies have shown that the administration of this type of antibody may help to prevent tumors from growing.
In the laboratory, adding avelumab and Utomilumab to trastuzumab appears to improve effectiveness. It is not known whether this is true in humans.
In this research study, the investigators are evaluating the activity of 3 different combinations: (a)trastuzumab and vinorelbine combined, (b) trastuzumab, vinorelbine and avelumab combined, and (c) trastuzumab, vinorelbine, avelumab and utomilumab combined in participants with metastatic HER2- positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NH: Trastuzumab + Vinorelbine | Experimental | Drug: Vinorelbine, Drug: Trastuzumab* Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle |
| NHA: Trastuzumab + Vinorelbine + Avelumab | Experimental | Drug: Vinorelbine, Drug: Trastuzumab, Drug: Avelumab* Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab |
| NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab | Experimental | Drug: Vinorelbine, Drug: Trastuzumab, Drug: Avelumab, Drug: Utomilumab* Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥18 years or older
- Histologically confirmed breast adenocarcinoma that is unresectable loco-regionally advanced or metastatic
- HER2-positive (immunohistochemistry score 3+) or ERBB2- amplification (Ratio ERBB2/centromeres ≥ 2.0 or mean gene copy number ≥ 6) on primary tumor or of metastatic or unresectable loco-regional biopsy.
- Measurable disease per RECIST v1.1 (see Section 11)
- Patients must have previous treatment with ado-trastuzumab emtansine (Kadcyla, T-DM1) in any setting. Patients must have previously received trastuzumab and pertuzumab in the metastatic setting or within 12 months of neoadjuvant/adjuvant treatment.
Key exclusion criteria (15 listed)
- Prior therapy with any anti-PD-1, anti-PD-L1, L2, anti-4-1BB (CD137), or anti-CTLA4 therapy
- Known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Positive for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA [qualitative]).
- History of interstitial lung disease
- Active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically stable for at least 4 weeks before first dose of investigational product and do not require high-dose steroid treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinorelbinework by interfering with cell division, which leaves the tumor unable to grow and spread | Drug | NH: Trastuzumab + Vinorelbine, NHA: Trastuzumab + Vinorelbine + Avelumab, NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab |
| Trastuzumabtrastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. | Drug | NH: Trastuzumab + Vinorelbine, NHA: Trastuzumab + Vinorelbine + Avelumab, NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab |
| Avelumabmonoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein | Drug | NHA: Trastuzumab + Vinorelbine + Avelumab, NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab |
| UtomilumabUtomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells | Drug | NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab |
Primary outcome
Progression Free Survival
Time frame: 2 years
Progression Free Survival is defined from the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs first.
3 secondary outcomes
Objective Response Rate
Time frame: 2 years
Duration of Response
Time frame: 3 years
Overall Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Waks, MD, PhD principal investigator
Dana-Farber Cancer Institute
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine, Trastuzumab and Avelumab in people with Breast Cancer, run by Adrienne G. Waks at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.