MelanomaPhase 2NCT04577807
LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma
A Phase 2 study testing Lerapolturev and Anti-PD-1 Checkpoint Inhibitor in people with Melanoma, run by Istari Oncology, Inc. at 12 sites in United States.
Trial summary
A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Lerapolturev and Anti-PD-1 Checkpoint Inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 12 sitesUnited States
- Study dates
- 17 Nov 2020to 15 Nov 2024
- 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
- ≥ 18 years of age
- Prior CDC-recommended vaccination series against PV, and has received a boost immunization with trivalent IPOL® (Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to Day 1
- NOTE: Patients who are unsure of their vaccination status must provide evidence of anti-PV immunity prior to enrollment, as applicable
- Has biopsy proven unresectable cutaneous melanoma and is willing to undergo tumor biopsy prior to the first dose of study drugs and at prespecified intervals during the study
- Patients with ocular, acral or mucosal melanoma are not eligible
- Patients with M1c or M1d disease are NOT eligble.
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- Submission of an archival biopsy sample is allowed in lieu of the baseline tumor biopsy, provided the tissue is ≤4 months old and the participant received no intervening systemic/intratumoral anti-cancer therapy since the biopsy was acquired.
- Must have at least 1 lesion that is amenable to biopsy. The lesion must be safely accessible as determined by the investigator and should not be located at sites that require significant risk procedures to biopsy. Examples of sites considered to be of significant risk include but are not limited to the following: the brain, lung, mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel wall.
- Has ≥ 2 melanoma lesions that are accurately measurable by caliper or a radiological method according to RECIST 1.1 criteria
- One lesion must be injectable- defined as a visible or palpable cutaneous, subcutaneous, or nodal melanoma lesion ≥10 mm in longest diameter or multiple injectable melanoma lesions which in aggregate have a longest diameter of ≥10 mm and where the minimum lesion size is ≥5 mm
- Note that visceral lesions (eg, liver, lung, retroperitoneal, subpleural lesions) are not considered injectable for the purposes of this trial.
- Has had confirmed progression of disease (PD) while receiving at least 6 weeks (> 1 dose) of an FDA-approved anti-PD-1/L1 therapy (as monotherapy or in combination) for the treatment of melanoma. Note the following details:
- Initial PD as defined by RECIST v1.1
- Confirmation of PD per iRECIST must occur by repeat assessment ≥ 4 weeks from initial evidence of PD, in the absence of rapid clinical progression.
- Those who discontinue anti-PD-1/L1 therapy after at least 6 weeks (> 1 dose) and have confirmed PD per iRECIST within 12 weeks of their last anti-PD-1/L1 dose are also eligible, provided the anti-PD-1/L1 was not stopped due to toxicity requiring permanent discontinuation
- Those treated with anti-PD-1/L1 in the adjuvant setting and who have biopsy-confirmed progression either while receiving anti-PD-1/L1-based therapy or ≤ 12 weeks after their last dose of anti-PD-1/L1 therapy are allowed NOTE: Adjuvant is defined as therapy received after surgical resection of disease such that the patient has no evidence of disease when the anti-PD-1/L1 therapy is initiated. Patients with known BRAF mutation must have also failed or refused to receive BRAF-targeted therapy (alone or in combination with MEK inhibitor) to be eligible.
- Eastern Cooperative Oncology Group (ECOG) status of 0-1
- Serum lactate dehydrogenase (LDH) levels ≤ 3 x upper limit of normal (ULN)
- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin ≥ 9.0 g/dl, patients may be transfused
- Lymphocyte count ≥ 0.5 x 10^9/L (500 µL)
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1500 µL)
- Platelet count ≥ 100 x 10^9/L (100,000 µL) without transfusion
- AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN), with the following exceptions: Patients with documented liver metastases: AST and ALT ≤ 5 x ULN; Patients with documented liver or bone metastases: ALP ≤ 5 x ULN
- Serum bilirubin ≤ 1.5 x ULN with the following exception: Patients with known Gilbert disease: serum bilirubin level ≤ 3 x ULN
- Measured or calculated (per institutional standards) creatinine clearance ≥ 30 ml/min (GRF can also be used in place of creatinine clearance)
- For patients not receiving therapeutic anticoagulation: INR, PT, PTT (or aPTT) ≤ 1.5 x ULN
- Life expectancy of >12 weeks
- Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for the study, and is willing/able to participate in the study
Who cannot join
- Has biopsy-proven ocular, acral or mucosal melanoma
- Has M1c or M1d disease
- No more than one prior systemic anti-cancer regimen (monotherapy or combination) for management of melanoma. Additional details noted below:
- Adjuvant anti-cancer therapy administered ≥ 6 months prior to the first injection of lerapolturev does NOT count as a line of treatment.
- Patients with BRAF mutant melanoma may enroll if they have received ≤ 2 prior lines of systemic anti-cancer therapy only if one of those lines of therapy was a BRAF-targeted regimen (alone or in combination with MEK inhibitor).
- A line of therapy is defined as a regimen in which at least 2 doses of systemic anti-cancer therapy (monotherapy or combination) was administered, and the regimen was discontinued because of progressive disease
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- Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry.
- Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period
- Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment
- Grade ≥2 pleural effusion, pericardial effusion, or ascites
- Active or history of autoimmune disease or immune deficiency within previous 2 years, with the following exceptions:
- History of autoimmune-related endocrinopathy (e.g. adrenal insufficiency, hypothyroidism, Type 1 diabetes mellitus, etc.) that is managed by hormone replacement therapy (e.g. hydrocortisone, thyroid hormone, insulin, etc.)
- Eczema, psoriasis, or lichen simplex chronicus with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded), provided all of the following conditions are met:
- Rash must cover <10% of body surface area
- Disease is well-controlled at baseline and requires only low-potency topical corticosteroids
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within 12 months of Day 1
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- History of radiation pneumonitis in the radiation field (fibrosis) is allowed.
- History of a positive HIV RNA test (HIV 1 or 2 RNA by PCR)
- Known active hepatitis B virus (HBV) infection (chronic or acute)
- NOTE: Participants with a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test are allowed.
- Known active hepatitis C virus (HCV) infection
- NOTE: History of a positive HCV antibody test, but negative HCV RNA test is allowed.
- Active tuberculosis
- Significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months of Day 1, unstable arrhythmia, or unstable angina
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 elimination half-lives- whichever is shorter, prior to treatment, or has not recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy are eligible
- Note: Anti-PD-1/L1 within 4 weeks prior to Day 1 is allowed
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- History of other malignancy within 2 years prior to Day 1, with the exception of those with a negligible risk of metastasis or death (e.g., resected cutaneous basal cell carcinoma, or other cancers with 5-year OS of >90%)
- Severe infection within 4 weeks prior to Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are allowed.
- Prior allogeneic stem cell or solid organ transplantation
- Treatment with a live, attenuated vaccine within 4 weeks prior to Day 1
- Treatment with systemic immunosuppressive medication within 4 weeks prior to Day 1, with the following exceptions:
- Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible
- Patients receiving mineralocorticoids (e.g., fludrocortisone), or systemic prednisone equivalent corticosteroid doses of <10mg per day are eligible for the study
- Known hypersensitivity to pembrolizumab, nivolumab, or any of the respective excipients
- Requires therapeutic anticoagulation and cannot discontinue anticoagulation safely during the day prior, day of, and day after each lerapolturev injection
- NOTE: Participants receiving anticoagulation with warfarin at the time of study entry are allowed if they can be transitioned to an alternative anticoagulant (eg, low molecular weight heparin or direct oral anticoagulants) prior to the first dose of lerapolturev. Anyone transitioned from warfarin to an oral anticoagulant prior to the first dose of lerapolturev should have an INR <1.5x upper limit of normal in order to participate. Antiplatelet agents (eg, aspirin, clopidogrel, etc.) are not considered anticoagulants for the purposes of this study (ie, are allowed)
- A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception starting from signed ICF through 150 days after last anti-PD-1 dose
- History of human serum albumin allergy
- History of neurological complications due to polio virus infection
- History of agammaglobulinemia
- Concurrent participation in a separate interventional clinical trial during this study.
- Any underlying medical condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromises the participant's well-being) or that could prevent, limit, or confound protocol-specified assessments
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rush University Medical Center
Chicago, Illinois, 60612
Texas Oncology -Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Henry Ford Health System
Detroit, Michigan, 48208
Hackensack University Medical Center
Hackensack, New Jersey, 07601
West Virginia University Medical Center
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Orlando Health U7 Health Cancer Center
Orlando, Florida, 32806
University of Pittsburgh Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University
Richmond, Virginia, 23298
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Cancer Treatment Centers of America
Zion, Illinois, 60099
About this study
Official title: Lerapolturev (Formerly Known as PVSRIPO) With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma
A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor.
Read the detailed description
This multi-center, open-label, randomized, Phase 2 will investigate the efficacy and safety of lerapolturev alone (Arm 1) or in combination with an anti-PD-1 inhibitor (Arm 2). Following a 6 participant safety run-in period, up to approximately 50 participants with cutaneous melanoma who previously failed anti-PD-1/L1-based therapy will be randomized 1:1 to receive either lerapolturev or lerapolturev plus an anti-PD-1.
- Conditions
- Melanoma
- Being tested
- Lerapolturev, Anti-PD-1 Checkpoint Inhibitor
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LerapolturevBiological
Lerapolturev administered via direct lesion injection
Anti-PD-1 Checkpoint InhibitorBiological
Anti-PD-1 Checkpoint Inhibitor administered per package insert instructions
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Lerapolturev | Experimental | Lerapolturev (up to 1.6x10^9 TCID50) administered via direct injection of up to 6 lesions Receives: Biological: Lerapolturev |
| Arm 2: Lerapolturev and anti-PD-1 | Experimental | Lerapolturev (up to 1.6x10^9 TCID50) administered via direct injection of up to 6 lesions. Anti-PD-1 therapy given as per the anti-PD-1 approved package insert. Receives: Biological: Lerapolturev; Biological: Anti-PD-1 Checkpoint Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response
The number of patients achieving confirmed complete (CR) or partial response (PR), per RECIST 1.1 criteria
Measured: 24 months
Number of Participants Experiencing a Treatment-emergent Adverse Event
The number of participants experiencing a treatment-emergent adverse event
Measured: 24 months
Number of Participants Experiencing an Adverse Event of Special Interest (AESI) or Anti-PD-1 Immune Related Adverse Events (irAEs)
The number of participants experiencing an AESI or irAE
Measured: 24 months
Number of Participants Discontinuing Study Treatment Due to Adverse Event(s)
Number of participants discontinuing study treatment due to adverse event(s)
Measured: 24 months
Changes From Baseline in the Number of CD8+ Tumor Infiltrating Lymphocytes (TILs)
Changes from baseline in the number of CD8+ tumor infiltrating lymphocytes (TILs)
Measured: 24 months
Changes From Baseline in PD-L1 Expression
Changes from baseline in PD-L1 expression
Measured: 24 months
Secondary outcomes (6)
Overall Survival
Overall survival (OS): time from treatment group assignment until death from any cause.
Measured: 24 months
Duration of Response
Duration of Response (DOR): time from confirmed objective response (CR or PR per RECIST 1.1) until unequivocal disease progression or death, whichever occurs first
Measured: 24 months
Disease Control Rate
The percentage of patients achieving confirmed CR, confirmed PR, or stable disease (SD) per RECIST1.1, as best response.
Measured: 24 months
DCR-6 Months
The number of patients achieving confirmed CR (any duration), confirmed PR (any duration) or SD (≥ 6 months) per RECIST 1.1 as best response.
Measured: 24 months
Durable Response Rate
The percentage of participants with confirmed CR or PR (per RECIST 1.1) lasting at least 6 months
Measured: 24 months
Progression-free Survival (PFS)
Progression-free survival (PFS): time (number of months) from treatment group assignment until date of documented radiologic disease progression per RECIST 1.1 or death due to any cause, whichever comes first
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start17 Nov 2020
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
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 MelanomaStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istari Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577807
- Sponsor's protocol ID
- LUMINOS-102
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2020
- Last updated
- 19 Sep 2025
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lerapolturev (Formerly Known as PVSRIPO) With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma
- ClinicalTrials.gov ID
- NCT04577807
- Acronym / sponsor ID
- LUMINOS-102
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Istari Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor.
Detailed description
This multi-center, open-label, randomized, Phase 2 will investigate the efficacy and safety of lerapolturev alone (Arm 1) or in combination with an anti-PD-1 inhibitor (Arm 2). Following a 6 participant safety run-in period, up to approximately 50 participants with cutaneous melanoma who previously failed anti-PD-1/L1-based therapy will be randomized 1:1 to receive either lerapolturev or lerapolturev plus an anti-PD-1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Lerapolturev | Experimental | Biological: LerapolturevLerapolturev (up to 1.6x10^9 TCID50) administered via direct injection of up to 6 lesions |
| Arm 2: Lerapolturev and anti-PD-1 | Experimental | Biological: Lerapolturev, Biological: Anti-PD-1 Checkpoint InhibitorLerapolturev (up to 1.6x10^9 TCID50) administered via direct injection of up to 6 lesions. Anti-PD-1 therapy given as per the anti-PD-1 approved package insert. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- ≥ 18 years of age
- Prior CDC-recommended vaccination series against PV, and has received a boost immunization with trivalent IPOL® (Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to Day 1
- Has biopsy proven unresectable cutaneous melanoma and is willing to undergo tumor biopsy prior to the first dose of study drugs and at prespecified intervals during the study
- Has ≥ 2 melanoma lesions that are accurately measurable by caliper or a radiological method according to RECIST 1.1 criteria
- Has had confirmed progression of disease (PD) while receiving at least 6 weeks (> 1 dose) of an FDA-approved anti-PD-1/L1 therapy (as monotherapy or in combination) for the treatment of melanoma. Note the following details:
Key exclusion criteria (45 listed)
- Has biopsy-proven ocular, acral or mucosal melanoma
- Has M1c or M1d disease
- No more than one prior systemic anti-cancer regimen (monotherapy or combination) for management of melanoma. Additional details noted below:
- Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry.
- Grade ≥2 pleural effusion, pericardial effusion, or ascites
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 |
|---|---|---|
| LerapolturevLerapolturev administered via direct lesion injection | Biological | Arm 1: Lerapolturev, Arm 2: Lerapolturev and anti-PD-1 |
| Anti-PD-1 Checkpoint InhibitorAnti-PD-1 Checkpoint Inhibitor administered per package insert instructions | Biological | Arm 2: Lerapolturev and anti-PD-1 |
Primary outcome
Overall Response
Time frame: 24 months
The number of patients achieving confirmed complete (CR) or partial response (PR), per RECIST 1.1 criteria
Number of Participants Experiencing a Treatment-emergent Adverse Event
Time frame: 24 months
The number of participants experiencing a treatment-emergent adverse event
Number of Participants Experiencing an Adverse Event of Special Interest (AESI) or Anti-PD-1 Immune Related Adverse Events (irAEs)
Time frame: 24 months
The number of participants experiencing an AESI or irAE
Number of Participants Discontinuing Study Treatment Due to Adverse Event(s)
Time frame: 24 months
Number of participants discontinuing study treatment due to adverse event(s)
Changes From Baseline in the Number of CD8+ Tumor Infiltrating Lymphocytes (TILs)
Time frame: 24 months
Changes from baseline in the number of CD8+ tumor infiltrating lymphocytes (TILs)
Changes From Baseline in PD-L1 Expression
Time frame: 24 months
Changes from baseline in PD-L1 expression
6 secondary outcomes
Overall Survival
Time frame: 24 months
Duration of Response
Time frame: 24 months
Disease Control Rate
Time frame: 24 months
DCR-6 Months
Time frame: 24 months
Durable Response Rate
Time frame: 24 months
Progression-free Survival (PFS)
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 Lerapolturev and Anti-PD-1 Checkpoint Inhibitor in people with Melanoma, run by Istari Oncology, Inc. at 12 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 29 inclusion and 45 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: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 19 Sep 2025). 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?
Overall Response (time frame: 24 months). The study lists 6 primary outcomes in all. 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 19 Sep 2025.