MelanomaPhase 2/3NCT04695977
CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
A Phase 2/3 study testing CMP-001 and Nivolumab in people with Melanoma and Advanced Melanoma, run by Regeneron Pharmaceuticals at 20 sites in United States.
Trial summary
CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma. The study is divided into two phases: Phase 2 and Phase 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Advanced Melanoma, Metastatic Melanoma
- What is being tested?
- CMP-001 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 20 sitesUnited States
- Study dates
- 24 Feb 2021to 22 Jul 2024
- Phase
- Phase 2/3
- 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
- Subjects enrolled in the study must meet all of the following inclusion criteria to be eligible:
- Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma per AJCC Cancer Staging Manual Eighth Edition.
- Measurable disease, as defined by RECIST v1.1 and both of the following:
- At least 1 accessible lesion amenable to repeated IT injection
- One or more measurable lesions at least 1 cm in diameter that are not intended for CMP-001 injection and can be followed as target lesions per RECIST v1.1
- Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the first dose of study treatment) is preferred, but an archival sample is acceptable if no intervening therapy for melanoma/cancer was received. Note: for tissue sampling details, please refer to the Laboratory Manual.
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- Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study treatment on Week 1 Day 1 (W1D1):
- Bone marrow function:
- neutrophil count ≥1500/mm3
- platelet count ≥ 100 000/mm3
- hemoglobin concentration ≥9 g/dL
- white blood cells ≥2000/mm3
- Liver function:
- total bilirubin ≤1.5 × the upper limit of normal (ULN) with the following exception: subjects with Gilbert Disease total serum bilirubin ≤3 × ULN
- aspartate aminotransferase and alanine aminotransferase ≤3 ×ULN
- Lactate dehydrogenase ≤2 × ULN
- Renal function: estimated (Cockcroft-Gault) or measured creatinine clearance ≥30 mL/min
- Coagulation
- International normalized ratio or prothrombin time (PT) ≤ 1.5 × ULN, unless subject is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time or PTT ≤1.5 × ULN, unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Eastern Cooperative Oncology Group Performance Status of 0 to 1 at Screening.
- Age ≥18 years at time of consent.
- Capable of understanding and complying with protocol requirements.
- Women of childbearing potential must have negative serum pregnancy test prior to dosing at W1D1 and be willing to use an adequate method of contraception from the time of consent until at least 150 days after the last dose of study treatment.
- Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 210 days after the last dose of study treatment.
- Able and willing to provide written informed consent and to follow study instructions.
- Subjects unable to provide written informed consent on their own behalf will not be eligible for the study.
Who cannot join
- Subjects presenting with any of the following will not qualify for entry into the study:
- Uveal, acral, or mucosal melanoma.
- Received prior systemic treatment for melanoma in the unresectable or metastatic setting. Prior adjuvant therapy is acceptable if the treatment course (of approximately 1 year duration) was completed and there was no recurrence within 6 months of the last dose of adjuvant treatment.
- Received prior therapy with CMP-001.
- Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study treatment on W1D1.
- Subjects who are currently receiving steroids at a prednisone-equivalent dose of ≤10 mg/day do not need to discontinue steroids prior to enrollment.
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- Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
- History of CTCAE v5.0 Grade 4 immune-related AE due to adjuvant CTLA-4 or PD-1 blocking antibody.
- Not fully recovered from adverse events (to Grade 1 or less [per CTCAE v5.0], with the exception of persistent alopecia, adrenal insufficiency, and hypothyroidism) due to prior treatment.
- Active pneumonitis, history of pneumonitis that required steroids, or history of interstitial lung disease.
- Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, and implanted or continuous use of a pacemaker or defibrillator.
- Known history of immunodeficiency.
- Known additional malignancy that has progressed or required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, curatively treated localized prostate cancer with prostate-specific antigen level below 4.0 ng/mL, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, thyroid cancer (except anaplastic), and adjuvant hormonal therapy for breast cancer >3 years from curative-intent surgical resection.
- Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
- Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).
- Prior allogenic tissue/solid organ transplant.
- Known or suspected active infection with severe acute respiratory syndrome coronavirus 2 virus (SARS-CoV-2).
- Active infection requiring systemic therapy.
- Known or suspected infection with HIV, hepatitis B virus, or hepatitis C virus; testing is not required unless suspected.
- Received a live/attenuated virus vaccination within 30 days prior to the first dose of study treatment on W1D1.
- Received blood products (including platelets or red blood cells) or colony stimulating factors (including granulocyte colony stimulating factor, granulocyte/macrophage colony stimulating factor, or recombinant erythropoietin) within 30 days prior to the start of Screening.
- History of allergy or hypersensitivity to nivolumab and/or any of its excipients.
- Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.
- Participation in another clinical study of an investigational anticancer therapy or device within 30 days before the first dose of study treatment on W1D1.
- Note: Participation in the follow-up phase (receiving no study treatment) of a prior study is allowed.
- Requires prohibited treatment (ie, non-protocol specified anticancer pharmacotherapy, surgery, or radiotherapy) for treatment of malignant tumor.
- Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator.
- Pregnant or breast-feeding or expecting to conceive or donate eggs within the projected duration of the study, from the time of consent until at least 150 days after the last dose of study treatment for women.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University Cancer & Blood Center
Athens, Georgia, 30607
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Texas Oncology, Sammons Cancer Center
Dallas, Texas, 75246
Duke University Cancer Institute
Durham, North Carolina, 27710
Hartford Healthcare
Hartford, Connecticut, 06106
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Moores Cancer Center at UC San Diego Health
La Jolla, California, 92093
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of California, Los Angeles
Los Angeles, California, 90095
University of Louisville Health Care
Louisville, Kentucky, 40202
West Virginia University
Morgantown, West Virginia, 26506
Atlantic Health
Morristown, New Jersey, 07960
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic Arizona
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center / Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
California Cancer Associates for Research & Excellence, Inc.
San Marcos, California, 92069
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Cleveland Clinic
Weston, Florida, 33331
About this study
Official title: A Randomized, Open-label, Active-control, Phase 2/3 Study of First-line Intratumoral CMP-001 in Combination With Intravenous Nivolumab Compared to Nivolumab Monotherapy in Subjects With Unresectable or Metastatic Melanoma
CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma.
The study is divided into two phases: Phase 2 and Phase 3.
Read more
The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma.
The secondary objectives of Phase 3 are to:
- To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
- To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
Read the detailed description
Former Sponsor Checkmate Pharmaceuticals
- Being tested
- CMP-001, Nivolumab
- Keywords
- vidutolimod
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMP-001Drug
Also called vidutolimod
Subjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W).
NivolumabDrug
Also called OPDIVO
Nivolumab 360 mg IV is administered Q3W.
| Study group | Role | What they receive |
|---|---|---|
| CMP-001 and Nivolumab | Experimental | All enrolled subjects will receive CMP-001 IT and nivolumab IV according to the treatment schedule until a reason for treatment discontinuation is reached. Receives: Drug: CMP-001; Drug: Nivolumab |
| Nivolumab Monotherapy | Experimental | All enrolled subjects will receive nivolumab monotherapy IV according to the treatment schedule until a reason for treatment discontinuation is reached. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST vl.l) as assessed by Blinded Independent Central Review (BICR)
Measured: Up to approximately 39 months
Secondary outcomes (10)
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.
Measured: Up to approximately 28 months (122 weeks)
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living; Grade 4 Life-threatening consequences: urgent intervention indicated; Grade 5 Death related to adverse event.
Measured: Up to approximately 28 months (122 weeks)
Time to Response (TTR) by BICR
TTR, defined as the time from the date of randomization to the first time when criteria are first met for complete response (CR) or partial response (PR), whichever occurred first, per RECIST vl.1 by BICR.
Measured: Up to approximately 39 months
Time to Response (TTR) by Investigator
TTR, defined as the time from the date of randomization to the first time when criteria are first met for CR or PR, whichever occurred first, per RECIST vl.1 by Investigator.
Measured: Up to approximately 39 months
Duration of Response (DOR) by BICR
DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST vl.1 by BICR or death, whichever occurred first.
Measured: Up to approximately 39 months
Duration of Response (DOR) by Investigator
DOR, defined as time from the date of first documented response (CR or PR) to the date of documented progressive disease (PD), based on RECIST vl.1 by Investigator or death, whichever occurred first.
Measured: Up to approximately 39 months
Confirmed ORR in Non-injected Target Lesions by Investigator
Confirmed ORR, defined as the percentage of participants in the analysis set who had confirmed BOR of CR or PR based on RECIST vl.1 as assessed by Investigator.
Measured: Up to approximately 39 months
Progression-free Survival (PFS) by BICR
PFS, defined as the time from the date of randomization to date of documented PD based on RECIST vl.1 by BICR or death, whichever occurred first.
Measured: Up to approximately 39 months
Progression-free Survival (PFS) by Investigator
PFS, defined as the time from the date of randomization to date of documented PD based on RECIST vl.1 by Investigator or death, whichever occurred first.
Measured: Up to approximately 39 months
Overall Survival (OS) by Investigator
OS, defined as the time from the date of randomization to the date of death from any cause.
Measured: Up to approximately 40 months (174 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start24 Feb 2021
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Why it stopped: Business Decision
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.
- More trials run by Regeneron PharmaceuticalsThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695977
- Sponsor's protocol ID
- CMP-001-011
- Status last verified
- May 2026
- First submitted
- 10 Dec 2020
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Active-control, Phase 2/3 Study of First-line Intratumoral CMP-001 in Combination With Intravenous Nivolumab Compared to Nivolumab Monotherapy in Subjects With Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT04695977
- Acronym / sponsor ID
- CMP-001-011
- Keywords
- vidutolimod
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Posted 5 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma.
The study is divided into two phases: Phase 2 and Phase 3.
The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma.
The secondary objectives of Phase 3 are to:
- To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
- To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
Detailed description
Former Sponsor Checkmate Pharmaceuticals
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMP-001 and Nivolumab | Experimental | Drug: CMP-001, Drug: NivolumabAll enrolled subjects will receive CMP-001 IT and nivolumab IV according to the treatment schedule until a reason for treatment discontinuation is reached. |
| Nivolumab Monotherapy | Experimental | Drug: NivolumabAll enrolled subjects will receive nivolumab monotherapy IV according to the treatment schedule until a reason for treatment discontinuation is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Subjects enrolled in the study must meet all of the following inclusion criteria to be eligible:
- Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma per AJCC Cancer Staging Manual Eighth Edition.
- Measurable disease, as defined by RECIST v1.1 and both of the following:
- Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the first dose of study treatment) is preferred, but an archival sample is acceptable if no intervening therapy for melanoma/cancer was received. Note: for tissue sampling details, please refer to the Laboratory Manual.
- Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study treatment on Week 1 Day 1 (W1D1):
Key exclusion criteria (28 listed)
- Uveal, acral, or mucosal melanoma.
- Received prior systemic treatment for melanoma in the unresectable or metastatic setting. Prior adjuvant therapy is acceptable if the treatment course (of approximately 1 year duration) was completed and there was no recurrence within 6 months of the last dose of adjuvant treatment.
- Received prior therapy with CMP-001.
- Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study treatment on W1D1.
- History of CTCAE v5.0 Grade 4 immune-related AE due to adjuvant CTLA-4 or PD-1 blocking antibody.
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 |
|---|---|---|
| CMP-001Also: vidutolimodSubjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W). | Drug | CMP-001 and Nivolumab |
| NivolumabAlso: OPDIVONivolumab 360 mg IV is administered Q3W. | Drug | CMP-001 and Nivolumab, Nivolumab Monotherapy |
Primary outcome
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 39 months
ORR, defined as the percentage of participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST vl.l) as assessed by Blinded Independent Central Review (BICR)
10 secondary outcomes
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Time frame: Up to approximately 28 months (122 weeks)
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: Up to approximately 28 months (122 weeks)
Time to Response (TTR) by BICR
Time frame: Up to approximately 39 months
Time to Response (TTR) by Investigator
Time frame: Up to approximately 39 months
Duration of Response (DOR) by BICR
Time frame: Up to approximately 39 months
Duration of Response (DOR) by Investigator
Time frame: Up to approximately 39 months
Confirmed ORR in Non-injected Target Lesions by Investigator
Time frame: Up to approximately 39 months
Progression-free Survival (PFS) by BICR
Time frame: Up to approximately 39 months
Progression-free Survival (PFS) by Investigator
Time frame: Up to approximately 39 months
Overall Survival (OS) by Investigator
Time frame: Up to approximately 40 months (174 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Summary is available on TrialSummaries.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CMP-001 and Nivolumab in people with Melanoma and Advanced Melanoma, run by Regeneron Pharmaceuticals at 20 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 27 inclusion and 28 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: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 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?
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) (time frame: Up to approximately 39 months). 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 15 Jun 2026.