Adult Nasal Type Extranodal NK/T-cell LymphomaPhase 1NCT01769222
Ipilimumab and Local Radiation for Selected Solid Tumors
A Phase 1 study testing Ipilimumab and Radiation therapy in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by Stanford University at 1 site in United States.
Trial summary
This pilot phase 1-2 trial studies the side effects and best of dose ipilimumab when given together with local radiation therapy and to see how well it works in treating patients with recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- Ipilimumab and Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2015
- Phase
- Phase 1
- 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
- Willing and able to give written informed consent
- Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel
- Histologically confirmed malignancy
- In Phase 1, histologically confirmed melanoma.
- In Phase 2, histologically confirmed melanoma, non-Hodgkin lymphoma, or colorectal carcinoma
- Must have failed at least 1 systemic therapy or be intolerant to at least one prior systemic treatment
Show all 25Show fewer
- Must have at least 2 lesions of evaluable size by modified World Health Organization (mWHO)/Cheson criteria; 1 of 2 lesions must be amenable to biopsy (core or fine needle aspirate) and intratumoral injection of up to 5 mL (diameter ≥ 10mm)
- Subjects with asymptomatic brain metastases are eligible; (systemic steroids should be avoided if possible, or the subject should be stable on the lowest clinically effective dose, as steroids as they may interfere with the activity of ipilimumab if administered at the time of the first ipilimumab dose)
- Must be at least 28 days since treatment with standard or investigational chemotherapy, biochemotherapy, surgery, radiation, cytokine therapy, or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of ≥ 16 weeks
- Subjects must have baseline (screening/baseline) radiographic images, (e.g. brain, chest, abdomen, pelvis, and bone scans with specific imaging tests to be determined by the attending physician) within 6 weeks of initiation of ipilimumab
- White blood cell (WBC) ≥ 2000/uL (~2 x 10^9/L)
- Absolute neutrophil count (ANC) ≥ 1000/uL (~0.5 x 10^9/L)
- Platelets ≥ 75 x 10^3/uL (~75 x 10^9/L)
- Hemoglobin ≥ 9 g/dL (may be transfused)
- Creatinine ≤ 2.0 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x ULN for subjects without liver metastasis ≤ 5 times for liver metastases
- Bilirubin ≤ 2.0 x ULN (except for subjects with Gilbert's syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
- No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:
- Amenorrhea ≥ 12 consecutive months without another cause, or
- For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level ≥ 35 mIU/mL
- Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of ipilimumab
- Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
Who cannot join
- Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
- Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis)
- Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
- Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
- A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist
Show all 17Show fewer
- Concomitant therapy with any of the following: interleukin-2 (IL 2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids
- A history of AEs with prior IL-2 or Interferon will not preclude subjects from entering the current study
- Any investigational agents
- Immunosuppressive agents (unless required for treating potential AEs)
- Chronic systemic corticosteroids (unless required for treating treatment emergent AEs or required for management of signs or symptoms due to brain metastases, upon discussion with Bristol-Myers Squibb [BMS] medical monitor)
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness
- Women of childbearing potential (WOCBP) who:
- Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 8 weeks after cessation of study drug, or
- Have a positive pregnancy test at baseline, or
- Are pregnant or breastfeeding
- Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 8 weeks after ipilimumab is stopped; sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Intratumoral Injection of Ipilimumab in Combination With Local Radiation in Melanoma, Non-Hodkgkin Lymphoma and Colorectal Carcinoma
This pilot phase 1-2 trial studies the side effects and best of dose ipilimumab when given together with local radiation therapy and to see how well it works in treating patients with recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer cells. Giving monoclonal antibody therapy together with radiation therapy may be an effective treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer.
- The phase 1 component ("safety") of this study is ipilimumab 25 mg monotherapy.
- The phase 2 component ("treatment-escalation") of this study is ipilimumab 25 mg plus radiation combination therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety of combining intratumoral anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) immunotherapy with local radiation therapy in patients with melanoma, non-Hodgkin lymphoma, and colorectal carcinoma with a monotherapy ipilimumab safety lead-in.
SECONDARY OBJECTIVES:
- To assess the induction of an anti-tumor immune responses using laboratory correlative studies.
- To determine tumor response rates and duration of response at unirradiated tumor sites in patients with advanced malignancies.
- To identify putative immunologic biomarkers of tumor response.
OUTLINE: This is a phase I safety study of ipilimumab monotherapy, followed by a phase 2 study. Only a few subjects participated in the phase 1 portion of this study. The phase 2 treatment-escalation portion of this study (ipilimumab plus radiation combination therapy) was not conducted.
Patients receive ipilimumab intratumorally on day 1 and undergo local radiation therapy within 48 hours for at least 3 fractions.
After completion of study treatment, patients are followed up at 4 and 8 weeks, and then every 24 weeks for 5 years.
- Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma
- Being tested
- Ipilimumab, Radiation therapy
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Lymphoma, T-Cell, Peripheral, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody, MDX-010, MDX-CTLA-4, Monoclonal antibody CTLA-4
Given intratumorally
Radiation therapyRadiation
Also called Irradiation, Radiotherapy, Therapy, radiation
Undergo local radiation therapy, 10 Gy x 3 fractions
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab 25 mg (Phase 1) | Experimental | Participants receive ipilimumab intratumorally on Day 1 Receives: Biological: Ipilimumab |
| Ipilimumab 25 mg and radiation therapy (Phase 2) | Experimental | Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Receives: Biological: Ipilimumab; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity
Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 4 weeks
Secondary outcomes (5)
Immune Response (Phase 2 Only)
Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Measured: 4 weeks
Immune Response (Phase 2 Only)
Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Measured: 8 weeks
Response Rate (Phase 2 Only)
Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Measured: 8 weeks
Overall Survival (Phase 2 Only)
Data will be summarized using Kaplan-Meier estimates for time to event data.
Measured: Up to 5 years
Duration of Response (Phase 2 Only)
Data will be summarized using Kaplan-Meier estimates for time to event data.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionJun 2015
Why it stopped: Planned Future Study
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 Adult Nasal Type Extranodal NK/T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Phase 1 ipilimumab 25 mg safety only. Subsequent Phase 2 ipilimumab 25 mg and radiation combination (treatment-escalation) was not conducted.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Albert Fisher, Stanford University
- Investigators
- George A. Fisher, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769222
- Sponsor's protocol ID
- IRB-25597
- Other IDs
- NCI-2012-02988, VAR0090, 5136
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2013
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Intratumoral Injection of Ipilimumab in Combination With Local Radiation in Melanoma, Non-Hodkgkin Lymphoma and Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT01769222
- Acronym / sponsor ID
- IRB-25597
- Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Planned Future Study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Posted 3 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot phase 1-2 trial studies the side effects and best of dose ipilimumab when given together with local radiation therapy and to see how well it works in treating patients with recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer cells. Giving monoclonal antibody therapy together with radiation therapy may be an effective treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer.
- The phase 1 component ("safety") of this study is ipilimumab 25 mg monotherapy.
- The phase 2 component ("treatment-escalation") of this study is ipilimumab 25 mg plus radiation combination therapy.
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety of combining intratumoral anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) immunotherapy with local radiation therapy in patients with melanoma, non-Hodgkin lymphoma, and colorectal carcinoma with a monotherapy ipilimumab safety lead-in.
SECONDARY OBJECTIVES:
- To assess the induction of an anti-tumor immune responses using laboratory correlative studies.
- To determine tumor response rates and duration of response at unirradiated tumor sites in patients with advanced malignancies.
- To identify putative immunologic biomarkers of tumor response.
OUTLINE: This is a phase I safety study of ipilimumab monotherapy, followed by a phase 2 study. Only a few subjects participated in the phase 1 portion of this study. The phase 2 treatment-escalation portion of this study (ipilimumab plus radiation combination therapy) was not conducted.
Patients receive ipilimumab intratumorally on day 1 and undergo local radiation therapy within 48 hours for at least 3 fractions.
After completion of study treatment, patients are followed up at 4 and 8 weeks, and then every 24 weeks for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 ipilimumab 25 mg safety only. Subsequent Phase 2 ipilimumab 25 mg and radiation combination (treatment-escalation) was not conducted.
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab 25 mg (Phase 1) | Experimental | Biological: IpilimumabParticipants receive ipilimumab intratumorally on Day 1 |
| Ipilimumab 25 mg and radiation therapy (Phase 2) | Experimental | Biological: Ipilimumab, Radiation: Radiation therapyParticipants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Willing and able to give written informed consent
- Histologically confirmed malignancy
- Must have failed at least 1 systemic therapy or be intolerant to at least one prior systemic treatment
- Must have at least 2 lesions of evaluable size by modified World Health Organization (mWHO)/Cheson criteria; 1 of 2 lesions must be amenable to biopsy (core or fine needle aspirate) and intratumoral injection of up to 5 mL (diameter ≥ 10mm)
- Subjects with asymptomatic brain metastases are eligible; (systemic steroids should be avoided if possible, or the subject should be stable on the lowest clinically effective dose, as steroids as they may interfere with the activity of ipilimumab if administered at the time of the first ipilimumab dose)
Key exclusion criteria (17 listed)
- Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
- Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis)
- Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
- Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
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 |
|---|---|---|
| IpilimumabAlso: Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody, MDX-010, MDX-CTLA-4, Monoclonal antibody CTLA-4Given intratumorally | Biological | Ipilimumab 25 mg (Phase 1), Ipilimumab 25 mg and radiation therapy (Phase 2) |
| Radiation therapyAlso: Irradiation, Radiotherapy, Therapy, radiationUndergo local radiation therapy, 10 Gy x 3 fractions | Radiation | Ipilimumab 25 mg and radiation therapy (Phase 2) |
Primary outcome
Dose-limiting Toxicity
Time frame: 4 weeks
Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
5 secondary outcomes
Immune Response (Phase 2 Only)
Time frame: 4 weeks
Immune Response (Phase 2 Only)
Time frame: 8 weeks
Response Rate (Phase 2 Only)
Time frame: 8 weeks
Overall Survival (Phase 2 Only)
Time frame: Up to 5 years
Duration of Response (Phase 2 Only)
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- 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.
George A. Fisher, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ipilimumab and Radiation therapy in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by Stanford University at 1 site 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 25 inclusion and 17 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Mar 2017). 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?
Dose-limiting Toxicity (time frame: 4 weeks). 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 24 Jan 2024.