NeuroblastomaPhase 1NCT04239040
GVAX Plus Checkpoint Blockade in Neuroblastoma
A Phase 1 study testing Tissue collection, GVAX vaccine and Nivolumab in people with Neuroblastoma and Pediatric Solid Tumor, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research clinical trial is studying the creation and administration of GVAX, an irradiated GM-CSF secreting, autologous neuroblastoma cell vaccine (GVAX) in combination with nivolumab and ipilimumab as a possible treatment for neuroblastoma. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Neuroblastoma, Pediatric Solid Tumor
- What is being tested?
- Tissue collection, GVAX vaccine and Nivolumab
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2020to 29 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligibility Criteria for neuroblastoma cell collection and vaccine manufacture
- Patients with histologically confirmed neuroblastoma, who meet the Children's Oncology Group (COG) high-risk group assignment criteria
- Lansky/Karnofsky performance status ≥50% (see Appendix A)
- Participants must have clinical indication for surgical resection of their neuroblastoma and undergo resection at Boston Children's Hospital
- Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.
- Eligibility Criteria to commence to receive study treatment with irradiated GM-CSF secreting autologous tumor vaccine, nivolumab, and ipilimumab
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- Histologically confirmed high-risk neuroblastoma based on COG assignment criteria
- Residual disease at the end of standard therapy or relapsed neuroblastoma in any disease state (including CR) by clinical criteria (histologic confirmation of relapse or residual disease is not required).
- Age > 1 year of age
- Lansky/Karnofsky performance status ≥50% (see Appendix A)
- Prior Therapy - Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimal duration from prior anti-cancer directed therapy prior to enrollment
- Myelosuppressive Chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy
- Small molecule biologic therapy: At least 7 days following the last dose of a biologic agent.
- Monoclonal antibodies ≥ 7 days or 3 half-lives whichever is longer but no longer than 30 days (with recovery of any associated toxicities)
- External beam irradiation: ≥ 14 days after small port XRT, ≥ 12 weeks after large port radiation (≥ 50% of the marrow space) including total body irradiation, craniospinal radiation, whole abdomen and whole lung radiation
- 131I- MIBG therapy ≥ 6 weeks
- Autologous stem cell infusion following myeloablative therapy ≥ 6 weeks
- Any other investigational agents ≥ 14 days
- Organ function requirements
- Adequate bone marrow function defined as:
- ANC >/= 500/µL
- Hgb >8 (may not be transfused)
- Platelet count ≥30,000 (may not be transfused)
- Hepatic Function:
- Total bilirubin ≤ 1.5 x upper limit of normal for age
- ALT (SGPT) ≤ 3 x upper limit of normal (135 U/L) For the purpose of this study, the ULN for ALT is 45 U/L
- Renal Function, a serum creatinine based on age/sex as follows:
- Maximum Serum Creatinine (mg/dL)
- Age 1 to <2 years Male: 0.6 Female: 0.6
- Age 2 to < 6 years Male:0.8 Female 0.8
- Age 6 to < 10 years Male:1 Female: 1
- Age 10 to < 13 years Male: 1.2 Female: 1.2
- Age 13 to < 16 years Male: 1.5 Female: 1.4
- Age ≥ 16 years Male: 1.7 Female: 1.4
- OR Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels greater than the above age/sex maximum allowed values
- Adequate Pulmonary Function Defined as:
- No evidence of dyspnea at rest
- No exercise intolerance due to pulmonary insufficiency
- Pulse oximetry > 92% while breathing room air
- Adequate pancreatic function defined as
- Serum lipase </= ULN at baseline.
- No ≥ Grade 2 non-hematologic toxicity
- Absolute eosinophil count ≤ 5000/ul
- Negative B-HCG pregnancy test in females of childbearing potential. Must be drawn or repeated within 24 hours prior to initial administration of study drugs
- Women of childbearing potential (WOCBP) receiving nivolumab will be agree to adhere to contraception for a period of 5 months after the last dose of nivolumab. Men receiving nivolumab and who are sexually active with WOCBP will agree to adhere to contraception for a period of 7 months after the last dose of nivolumab.
Who cannot join
- Participants who are receiving any other investigational agents.
- No systemic corticosteroid therapy, other than replacement therapy for adrenal insufficiency or transfusion premedication. Participants who are receiving or have received lympholytic steroid (>=40mg/m2 prednisone equivalent) therapy within 4 weeks of first anticipated vaccine administration are excluded, because high-dose steroid therapy is expected to significantly limit the ability of the immune system to respond to GVAX vaccination.
- Participants with known parenchymal brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to GM-CSF or DMSO.
- Participants with any form of primary immunodeficiency.
- Females who are pregnant are excluded from this study because GVAX is an investigational biologic 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 GVAX, breastfeeding should be discontinued if the mother is treated with GVAX
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- Uncontrolled intercurrent illness or serious uncontrolled medical disorder including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and/or pronounced disturbances of the electrical conduction system of the heart or psychiatric illness/social situations that would limit compliance with study requirements.
- Known HIV-positive participants on combination antiretroviral therapy are ineligible because of the effect of GVAX vaccination on the disease course is unknown and because the underlying disease is expected to limit the ability of the immune system to respond to GVAX vaccination.
- Clinically relevant known active infection including active hepatitis B or C or any other concurrent disease which in the judgment of the Investigator would make the subject inappropriate for enrollment on this study
- History of a malignancy other than neuroblastoma with exception of the following circumstances:
- Patients with a history of malignancy who have been adequately treated and have been disease-free for at least 2 years are not excluded.
- Patients with adequately treated active non-invasive cancers (such as non-melanomatous skin cancer or in-situ bladder, cervical and breast cancers) are not excluded.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2 or anti-CTLA4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. OX 40, CD137).
- Has active autoimmune disease that has required systemic treatment in the past 12 months, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are exceptions. Intermittent use of bronchodilators or local steroid injections are not excluded. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diagnoses not listed must be approved by the protocol chair.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institite
Boston, Massachusetts, 02115
About this study
Official title: A Phase 1 Study of Combination Nivolumab and Ipilimumab With Irradiated GM-CSF Secreting Autologous Neuroblastoma Cell Vaccine (GVAX) for Relapsed or Refractory Neuroblastoma
This research clinical trial is studying the creation and administration of GVAX, an irradiated GM-CSF secreting, autologous neuroblastoma cell vaccine (GVAX) in combination with nivolumab and ipilimumab as a possible treatment for neuroblastoma.
The names of the study drugs involved in this study are:
- GVAX Vaccine, an immunotherapy developed from surgically removed tumor tissue
- Nivolumab
- Ipilimumab
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved the GVAX vaccine as a treatment for any disease.
The U.S. Food and Drug Administration (FDA) has not approved nivolumab or ipilimumab for your specific disease but it has been approved for other uses.
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.
This phase 1 study will be conducted in 2 parts
- In the first part, participants will, as part of standard of care procedure to remove cancerous tissue, undergo neuroblastoma cell collection from a portion of resected tumor.
- Those cells will then be used to create the vaccine which will be stored for potential use during the second part of this research study.
- In the second part, participants who did not respond to standard therapy will receive the GVAX vaccine along with nivolumab and ipilimumab.
The study treatment will continue for up to 24 months and participants will be followed for 2 years after last study treatment (if received at least one vaccination).
- Conditions
- Neuroblastoma, Pediatric Solid Tumor
- Being tested
- Tissue collection, GVAX vaccine, Nivolumab, Ipilimumab
- Keywords
- Neuroblastoma, Pediatric Solid Tumor, Immunotherapy, GVAX Vaccine, Nivolumab, Ipilimumab
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue collectionProcedure or surgery
Collection of cancerous tissue to create GVAX vaccine or irradiated GMCSF-secreting autologous neuroblastoma cell vaccine at time of clinically indicated surgical procedure
GVAX vaccineBiological
Also called GMCSF-secreting autologous neuroblastoma cell vaccine
Vaccine injected weekly over initial 21 day cycle, biweekly for cycles 2-4 of 21 day cycle duration and cycles 5 and subsequent of 28 day cycle duration until vaccine supply is exhausted.
NivolumabDrug
Also called Opdivo
Intravenous infusion of nivolumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days
Intravenous infusion of nivolumab biweekly for cycle 5 and subsequent of 28 day cycle duration. Subsequent 28 day cycles will last up to 2 years.
IpilimumabDrug
Also called Yervoy
Intravenous infusion of ipilimumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days
| Study group | Role | What they receive |
|---|---|---|
| Relapsed or Refractory High Risk Neuroblastoma | Experimental | Tissue Collection of Cancerous cells during primary or clinically indicated surgical resection.
Manufacture and cryopreservation of vaccine. Treatment with vaccine, nivolumab and ipilimumab.
* Vaccine injected weekly over initial 21 day cycle, biweekly for cycles 2-4 of 21 day cycle duration and cycles 5 and subsequent of 28 day cycle duration until vaccine supply is exhausted.
* Intravenous infusion of nivolumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days
* Intravenous infusion of ipilimumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days
* Intravenous infusion of nivolumab biweekly for cycle 5 and subsequent of 28 day cycle duration. Subsequent 28 day cycles will last up to 2 years. Receives: Procedure: Tissue collection; Biological: GVAX vaccine; Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with grade 4 toxicities
To assess safety, the number of grade 4 toxicities associated with vaccine and nivolumab/ipilimumab using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5
Measured: Up to 2 years
Number of Participants to receive 6 vaccinations
Feasibility will be assessed by the ability to make vaccine from available biopsy material in quantities sufficient for six vaccinations, for a given patient. A success rate (number of patients for whom quantity sufficient for six vaccinations exist / total number of eligible patients) under 65% may imply that the method needs further development or that the amount of tissue available in this population limits the feasibility of this strategy. Total number of vaccine doses administered per patient will also be counted
Measured: Up to 2 years
Secondary outcomes (3)
Progression-free survival (PFS)
Kaplan-Meier plots, 1-year PFS estimate will be calculated, along with the standard errors
Measured: time from receipt of first GVAX vaccine dose to the earlier of progression, relapse or death due to disease up to 48 months
Overall best response
Each patient will be categorized as a responder (≥PR) or a non-responder (<PR) by INRC criteria
Measured: Start of the treatment until disease progression/recurrence up to 48 months
Overall Survival
Kaplan-Meier plots, 1-year OS estimates will be calculated, along with the standard errors
Measured: Time from receipt of the first GVAX vaccine dose to death due to any cause up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start29 Jan 2020
- Primary completion27 Jan 2024
- Study completion29 Feb 2024
Why it stopped: Manufacturing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Collins, MD, Dana-Farber Cancer Institute
- Investigators
- Natalie B Collins, MD, PHD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239040
- Sponsor's protocol ID
- 19-680
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2020
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Combination Nivolumab and Ipilimumab With Irradiated GM-CSF Secreting Autologous Neuroblastoma Cell Vaccine (GVAX) for Relapsed or Refractory Neuroblastoma
- ClinicalTrials.gov ID
- NCT04239040
- Acronym / sponsor ID
- 19-680
- Conditions
- Neuroblastoma, Pediatric Solid Tumor
- Keywords
- Neuroblastoma, Pediatric Solid Tumor, Immunotherapy, GVAX Vaccine, Nivolumab, Ipilimumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manufacturing issues
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research clinical trial is studying the creation and administration of GVAX, an irradiated GM-CSF secreting, autologous neuroblastoma cell vaccine (GVAX) in combination with nivolumab and ipilimumab as a possible treatment for neuroblastoma.
The names of the study drugs involved in this study are:
- GVAX Vaccine, an immunotherapy developed from surgically removed tumor tissue
- Nivolumab
- Ipilimumab
Detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved the GVAX vaccine as a treatment for any disease.
The U.S. Food and Drug Administration (FDA) has not approved nivolumab or ipilimumab for your specific disease but it has been approved for other uses.
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.
This phase 1 study will be conducted in 2 parts
- In the first part, participants will, as part of standard of care procedure to remove cancerous tissue, undergo neuroblastoma cell collection from a portion of resected tumor.
- Those cells will then be used to create the vaccine which will be stored for potential use during the second part of this research study.
- In the second part, participants who did not respond to standard therapy will receive the GVAX vaccine along with nivolumab and ipilimumab.
The study treatment will continue for up to 24 months and participants will be followed for 2 years after last study treatment (if received at least one vaccination).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsed or Refractory High Risk Neuroblastoma | Experimental | Procedure: Tissue collection, Biological: GVAX vaccine, Drug: Nivolumab, Drug: IpilimumabTissue Collection of Cancerous cells during primary or clinically indicated surgical resection. Manufacture and cryopreservation of vaccine. Treatment with vaccine, nivolumab and ipilimumab. * Vaccine injected weekly over initial 21 day cycle, biweekly for cycles 2-4 of 21 day cycle duration and cycles 5 and subsequent of 28 day cycle duration until vaccine supply is exhausted. * Intravenous infusion of nivolumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days * Intravenous infusion of ipilimumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days * Intravenous infusion of nivolumab biweekly for cycle 5 and subsequent of 28 day cycle duration. Subsequent 28 day cycles will last up to 2 years. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (45 listed)
- Eligibility Criteria for neuroblastoma cell collection and vaccine manufacture
- Eligibility Criteria to commence to receive study treatment with irradiated GM-CSF secreting autologous tumor vaccine, nivolumab, and ipilimumab
- Organ function requirements
Key exclusion criteria (15 listed)
- Participants who are receiving any other investigational agents.
- No systemic corticosteroid therapy, other than replacement therapy for adrenal insufficiency or transfusion premedication. Participants who are receiving or have received lympholytic steroid (>=40mg/m2 prednisone equivalent) therapy within 4 weeks of first anticipated vaccine administration are excluded, because high-dose steroid therapy is expected to significantly limit the ability of the immune system to respond to GVAX vaccination.
- Participants with known parenchymal brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to GM-CSF or DMSO.
- Participants with any form of primary immunodeficiency.
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 |
|---|---|---|
| Tissue collectionCollection of cancerous tissue to create GVAX vaccine or irradiated GMCSF-secreting autologous neuroblastoma cell vaccine at time of clinically indicated surgical procedure | Procedure or surgery | Relapsed or Refractory High Risk Neuroblastoma |
| GVAX vaccineAlso: GMCSF-secreting autologous neuroblastoma cell vaccineVaccine injected weekly over initial 21 day cycle, biweekly for cycles 2-4 of 21 day cycle duration and cycles 5 and subsequent of 28 day cycle duration until vaccine supply is exhausted. | Biological | Relapsed or Refractory High Risk Neuroblastoma |
| NivolumabAlso: OpdivoIntravenous infusion of nivolumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days Intravenous infusion of nivolumab biweekly for cycle 5 and subsequent of 28 day cycle duration. Subsequent 28 day cycles will last up to 2 years. | Drug | Relapsed or Refractory High Risk Neuroblastoma |
| IpilimumabAlso: YervoyIntravenous infusion of ipilimumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days | Drug | Relapsed or Refractory High Risk Neuroblastoma |
Primary outcome
The number of participants with grade 4 toxicities
Time frame: Up to 2 years
To assess safety, the number of grade 4 toxicities associated with vaccine and nivolumab/ipilimumab using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5
Number of Participants to receive 6 vaccinations
Time frame: Up to 2 years
Feasibility will be assessed by the ability to make vaccine from available biopsy material in quantities sufficient for six vaccinations, for a given patient. A success rate (number of patients for whom quantity sufficient for six vaccinations exist / total number of eligible patients) under 65% may imply that the method needs further development or that the amount of tissue available in this population limits the feasibility of this strategy. Total number of vaccine doses administered per patient will also be counted
3 secondary outcomes
Progression-free survival (PFS)
Time frame: time from receipt of first GVAX vaccine dose to the earlier of progression, relapse or death due to disease up to 48 months
Overall best response
Time frame: Start of the treatment until disease progression/recurrence up to 48 months
Overall Survival
Time frame: Time from receipt of the first GVAX vaccine dose to death due to any cause up to 48 months
Results and safety
The study was stopped early (reason given: Manufacturing issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Natalie B Collins, MD, PHD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tissue collection, GVAX vaccine and Nivolumab in people with Neuroblastoma and Pediatric Solid Tumor, run by Dana-Farber Cancer Institute at 2 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 45 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
The study was stopped early (reason given: Manufacturing issues). Results are not available in the source record.
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?
The number of participants with grade 4 toxicities (time frame: Up to 2 years). The study lists 2 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 Mar 2025.