Non-Small Cell Lung CancerPhase 2NA_00084192NCT01928576
Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.
A Phase 2 study testing Azacitidine, Entinostat and Nivolumab in people with Non-Small Cell Lung Cancer and Epigenetic Therapy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 5 sites in United States.
Trial summary
Response Rate Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Epigenetic Therapy
- What is being tested?
- Azacitidine, Entinostat and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Nov 2013to 4 Apr 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically proven stage IIIB, IV or recurrent non-small cell lung cancer. Patients must be willing to undergo a pre-treatment biopsy, either core needle biopsy or equivalent amount or via excisional specimen. (cytology specimen not acceptable for this purpose).
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. A CT scan of the abdomen and pelvis is not required for patients with no disease in these areas.
- Age >18 years. Because no dosing or adverse event data are currently available on the use of azacitidine with entinostat, or of Nivolumab, in patients <18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Life expectancy of greater than 12 weeks.
- Patients must have adequate organ and marrow function.
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- The effects of entinostat, azacitidine, and Nivolumab, on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for up to 23 weeks after the last dose of nivolumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men who are sexually active with women of childbearing potential must also use an adequate contraceptive method for up to 31 weeks after fhe last dose of nivolumab.
- Ability to understand and the willingness to sign a written informed consent document.
- All adenocarcinoma patients must be tested for ALK rearrangements and EGFR (Exon 19 Deletion and Exon 21 L8585R Substitution) mutations and must have been treated with EGFR or ALK TKI therapy if found to have an actionable alteration. If patients are KRAS positive, testing for ALK rearrangements and EGFR mutations is not applicable.
- All patients should have been offered a platinum-based chemotherapy. For EGFR/ALK wild type patients, no more than two prior chemotherapy-based lines of therapy for advanced or metastatic NSCLC is permitted. For EGFR mutated or ALK translocated patients, no more than three prior lines of therapy for advanced or metastatic NSCLC is permitted. Patients who refuse platinum based chemotherapy, may be allowed to enroll if they meet all other criteria.
- Patients who received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are eligible and the adjuvant or neoadjuvant chemotherapy will count as a line of therapy as above.
- Subjects with recurrent disease > 6 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen given to treat the recurrences, are eligible and do not count as another line of therapy for advanced disease.
- Subjects who received pemetrexed, bevacizumab, or erlotinib as maintenance therapy (nonprogressors with platinum-based doublet chemotherapy) and subsequently progressed after maintenance therapy, are eligible and do not count as a line of therapy. However, subject who received a tyrosine kinase inhibitor after failure of a prior platinum-based therapy, that tyrosine kinase inhibitor therapy would count as an additional line of therapy.
- Patients who have been treated with prior standard of care PD-1/L1 agents, alone or in combination with chemotherapy, are eligible. Patients previously treated on clinical trials with non PD-1/PD-L1 immunotherapy agents are eligible. Patients who have been treated with a PD-1/L1 agent in more than 1 line of therapy (as standard of care or in clinical trial) are not eligible.
- Arm-specific eligibility criteria
- Arm D: Anti-PD-1/PD-L1 treatment naïve patients only
- Arm E \& F: Anti-PD-1/PD-L1 treatment experienced patients: Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) or recurrent (Arm F=more than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
- Patients must have disease amenable to biopsy at the time of enrollment as biopsies are required for study participation.
Who cannot join
- Any active history of a known autoimmune disease. Subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a history of interstitial lung disease that has required intubation in the past (i.e. such as Asthma or COPD).
- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- Patients who are receiving any other anticancer therapy.
- Patients with uncontrolled brain metastases. Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks without the use of steroids or on stable or decreasing dose of < 10mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of carcinomatous meningitis are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to entinostat, azacitidine, or Nivolumab.
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- Known or suspected hypersensitivity to azacitidine or mannitol
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because entinostat, azacitidine, and Nivolumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with entinostat, azacitidine, or Nivolumab breastfeeding should be discontinued if the mother is treated on this protocol.
- HIV-positive patients are excluded. (Patients cannot have known history of HIV. Testing for it at baseline is not required unless it is suspected they may have it).
- Patients with active hepatitis B or hepatitis C are excluded. (Patients cannot have known history of hepatitis B or hepatitis C. Testing for it at baseline is not required unless it is suspected they may have it).
- Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Patients with malabsorption in the small intestine or other conditions that would preclude administration of oral medication.
- Prior therapy with DNA methyltransferase therapy or HDAC inhibitor therapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Julie Brahmer, MD
Baltimore, Maryland, 21224
Julie Brahmer, MD
Baltimore, Maryland, 21287
University of Southern California
Los Angeles, California, 90033
UPMC Cancer Center- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: A Phase II Study of Epigenetic Therapy With Azacitidine and Entinostat With Concurrent Nivolumab in Subjects With Metastatic Non-Small Cell Lung Cancer.
Response Rate
Read the detailed description
Objective response rate to Nivolumab preceded by epigenetic priming. Response will be assessed by RECIST 1.1 criteria, baseline scans for this assessment will be the baseline scans done within 4 weeks of enrollment.
- Conditions
- Non-Small Cell Lung Cancer, Epigenetic Therapy
- Being tested
- Azacitidine, Entinostat, Nivolumab, CC-486 300
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5-AZA, Vidaza
EntinostatDrug
NivolumabDrug
Also called Opdivo
CC-486 300Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm C | Experimental | Nivolumab 3mg/kg every 2 weeks until progression Receives: Drug: Nivolumab |
| Arm D | Experimental | Anti-PD-1/PD-L1 treatment naïve patients only
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg. Receives: Drug: Azacitidine; Drug: Entinostat; Drug: Nivolumab |
| Arm E | Experimental | Patients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg. Receives: Drug: Azacitidine; Drug: Entinostat; Drug: Nivolumab |
| Arm F | Experimental | Patients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy.
Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression
After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg. Receives: Drug: Azacitidine; Drug: Entinostat; Drug: Nivolumab |
| Arm A | Experimental | Anti-PD-1/PD-L1 treatment naïve patients only Every 28 days for 2 cycles Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10 Entinostat 7mg by mouth Days 3 and 10
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg Receives: Drug: Azacitidine; Drug: Entinostat; Drug: Nivolumab |
| Arm B | Experimental | Every 28 days for 2 cycles CC-486 300 mg by mouth days 1 - 21
Followed by:
Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg. Receives: Drug: Nivolumab; Drug: CC-486 300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response
Percentage of participants with response to combination Nivolumab and epigenetic therapy. Response will be assessed by RECIST 1.1 criteria, where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measured: 2 years
Secondary outcomes (4)
Progression Free Survival
Number of months from the time of randomization until radiologic (per RECIST 1.1) or clinical progression or death, whichever comes first.
Measured: 2 years
Time to Progression
Number of months from the time nivolumab begins until radiologic (per RECIST 1.1) or clinical progression is noted.
Measured: 2 years
Overall Survival
Number of months from the time of randomization until death. Estimation will be by the Kaplan-Meier method.
Measured: 2 years
Safety and Tolerability as Assessed by Number of Participants With Dose-limiting Toxicities
Number of participants who experience adverse events as defined by CTCAE v4.0 that require a dose reduction.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2013 (estimated)
- Study start6 Nov 2013
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
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 Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Rising Tide Foundation, Stand Up To Cancer, Bristol-Myers Squibb, Celgene, Syndax Pharmaceuticals, Rhone-Poulenc Rorer
- Responsible party
- Sponsor
- Investigators
- Julie Brahmer, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928576
- Sponsor's protocol ID
- J1353
- Other IDs
- NA_00084192, 119134, 117207, 121445, 119134, CA209-117
- Acronym
- NA_00084192
- Status last verified
- May 2024
- First submitted
- 21 Aug 2013
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Epigenetic Therapy With Azacitidine and Entinostat With Concurrent Nivolumab in Subjects With Metastatic Non-Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT01928576
- Acronym / sponsor ID
- NA_00084192 / J1353
- Conditions
- Non-Small Cell Lung Cancer, Epigenetic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Rising Tide Foundation, Stand Up To Cancer, Bristol-Myers Squibb, Celgene, Syndax Pharmaceuticals, Rhone-Poulenc Rorer
- Study start
- 6 Nov 2013 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 26 Aug 2013 (estimated)
- Results
- Posted 3 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Response Rate
Detailed description
Objective response rate to Nivolumab preceded by epigenetic priming. Response will be assessed by RECIST 1.1 criteria, baseline scans for this assessment will be the baseline scans done within 4 weeks of enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm C | Experimental | Drug: NivolumabNivolumab 3mg/kg every 2 weeks until progression |
| Arm D | Experimental | Drug: Azacitidine, Drug: Entinostat, Drug: NivolumabAnti-PD-1/PD-L1 treatment naïve patients only Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15 Followed by: Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg. |
| Arm E | Experimental | Drug: Azacitidine, Drug: Entinostat, Drug: NivolumabPatients must have had refractory (Arm E=less than 24 weeks from first dose of anti-PD-1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy. Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15 Followed by: Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg. |
| Arm F | Experimental | Drug: Azacitidine, Drug: Entinostat, Drug: NivolumabPatients must have had recurrent (Arm F=more than 24 weeks from first dose of anti-PD1/PD-L1) disease during or after anti-PD-1 or anti-PD-L1 therapy and, in the opinion of the investigator, must be unlikely to benefit from nivolumab monotherapy. Every 28 days for 6 cycles Azacitidine 40mg/m2 days 1-5 and 8-10 Entinostat 5mg Days 3 and 10 Nivolumab 3mg/kg Days 1 and 15 Followed by: Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg. |
| Arm A | Experimental | Drug: Azacitidine, Drug: Entinostat, Drug: NivolumabAnti-PD-1/PD-L1 treatment naïve patients only Every 28 days for 2 cycles Azacitidine 40mg/m2 subcutaneous days 1-6 and 8-10 Entinostat 7mg by mouth Days 3 and 10 Followed by: Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg |
| Arm B | Experimental | Drug: Nivolumab, Drug: CC-486 300Every 28 days for 2 cycles CC-486 300 mg by mouth days 1 - 21 Followed by: Nivolumab 3mg/kg every 2 weeks until progression After a patient has completed 6 months of nivolumab, they can receive nivolumab every 4 weeks instead of every 2 weeks. The dose for Nivolumab every 4 weeks is 480mg. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have histologically proven stage IIIB, IV or recurrent non-small cell lung cancer. Patients must be willing to undergo a pre-treatment biopsy, either core needle biopsy or equivalent amount or via excisional specimen. (cytology specimen not acceptable for this purpose).
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. A CT scan of the abdomen and pelvis is not required for patients with no disease in these areas.
- Age >18 years. Because no dosing or adverse event data are currently available on the use of azacitidine with entinostat, or of Nivolumab, in patients <18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Life expectancy of greater than 12 weeks.
Key exclusion criteria (14 listed)
- Any active history of a known autoimmune disease. Subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a history of interstitial lung disease that has required intubation in the past (i.e. such as Asthma or COPD).
- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- Patients who are receiving any other anticancer therapy.
- Patients with uncontrolled brain metastases. Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks without the use of steroids or on stable or decreasing dose of < 10mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of carcinomatous meningitis are not eligible.
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 |
|---|---|---|
| AzacitidineAlso: 5-AZA, Vidaza | Drug | Arm A, Arm D, Arm E, Arm F |
| Entinostat | Drug | Arm A, Arm D, Arm E, Arm F |
| NivolumabAlso: Opdivo | Drug | Arm A, Arm B, Arm C, Arm D, Arm E, Arm F |
| CC-486 300 | Drug | Arm B |
Primary outcome
Objective Response
Time frame: 2 years
Percentage of participants with response to combination Nivolumab and epigenetic therapy. Response will be assessed by RECIST 1.1 criteria, where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
4 secondary outcomes
Progression Free Survival
Time frame: 2 years
Time to Progression
Time frame: 2 years
Overall Survival
Time frame: 2 years
Safety and Tolerability as Assessed by Number of Participants With Dose-limiting Toxicities
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julie Brahmer, MD principal investigator
Johns Hopkins University
5 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 Azacitidine, Entinostat and Nivolumab in people with Non-Small Cell Lung Cancer and Epigenetic Therapy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 5 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 18 inclusion and 14 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 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 3 May 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?
Objective Response (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 3 May 2024; AzTrials last refreshed its copy on 3 Nov 2026.