Advanced Lung Non-Small Cell CarcinomaPhase 2NCT07543172
CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer
A Phase 2 study testing Adagrasib, Biospecimen Collection and Computed Tomography in people with Advanced Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase II trial tests how well giving CIMAvax-EGF with KRAS G12C inhibitor (sotorasib or adagrasib) for the treatment of patients with KRAS G12C mutated non small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- What is being tested?
- Adagrasib, Biospecimen Collection and Computed Tomography
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 1 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at the time of study treatment initiation
- Have pathologically (cytology or histology) confirmed diagnosis of NSCLC. Non-small cell carcinoma diagnosis without specific tissue of origin confirmation may be eligible with approval from primary investigator (PI) review
- Must be eligible for treatment with standard of care KRAS G12C inhibitors
- Documented KRAS G12C mutation. Testing will occur by standard of care next generation sequencing (NGS) testing and results will be available in the medical record
- Have at least 6-month life expectancy
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- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
- Platelets ≥ 70 x 10^9/L
- Hemoglobin ≥ 9 g/dL
- Plasma creatinine ≤ 1.5 x institution upper limit of normal (ULN)
- ALT (alanine aminotransferase) and aspartate aminotransferase (AST) ≤ 3 x ULN (ALT and AST ≤ 5 x ULN is acceptable if liver metastases are present)
- Total plasma bilirubin ≤ 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin ≤ 3 x ULN with direct bilirubin within normal range
- Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. 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
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Participant agrees to provide blood samples at the start of treatment and at multiple times during the study as well as research specimen allocation at the time of standard of care rebiopsy at the time of disease progression
Who cannot join
- Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug (see exception allowed for #2)
- Previously treated with KRAS G12C inhibitor (exception allowed for patients who started KRAS G12C inhibitor within 4 weeks of study enrollment)
- Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities
- Active/untreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 2 weeks prior to first administration of study drug. Previously treated brain metastasis allowed as long as not requiring steroids
- Leptomeningeal involvement regardless of treatment status
- Active, clinically serious infections or other serious uncontrolled medical conditions (exception allowed: patients taking prophylactic anti-viral, anti-fungal or antibiotics. Patients on long-term treatment for acid-fast or fungal organisms must have been on stable dosing of ant-infective regimen for at least 4 weeks of uninterrupted treatment and without associated common toxicity criteria (CTC) grade 2 or higher drug-related lab abnormalities within 4 weeks of study enrollment)
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- Had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery
- Currently receiving or has received systemic corticosteroids within 4 weeks prior to starting study drug for management of brain metastases, or who have not fully recovered from side effects of such treatment. Steroids for endocrine replacement or receipt of short course of steroids during this preceding 4-week period as supportive medication such as for drug allergy, anti-emetic, etc. is allowed
- Pregnant or nursing female participants
- Patients diagnosed with a secondary invasive cancer within 2 years prior to starting protocol therapy with the following exceptions: non-melanoma skin cancers, in-situ cancers, and prostate cancer Gleason ≤ to 6 (under surveillance or treated), early-stage node-negative estrogen receptor (ER) +/ progesterone receptor (PR) + breast cancer with Oncotype Dx score < 25 (adjuvant hormonal therapy allowed)
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:
- Myocardial infarction or arterial thromboembolic events within 30 days prior to enrollment or with severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease
- Patient has known hypersensitivity to the components of the study drugs or any analogs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
Grace K. Dy, 716-845-3099, Grace.Dy@RoswellPark.org
Grace K. Dy
About this study
Official title: Phase II Study of CIMAVAX-EGF in Combination With KRAS G12C Inhibitors as Treatment for Advanced Stage KRAS G12C Mutated NSCLC
This phase II trial tests how well giving CIMAvax-EGF with KRAS G12C inhibitor (sotorasib or adagrasib) for the treatment of patients with KRAS G12C mutated non small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Vaccines, such as CIMAvax-EGF, made from specific peptides or antigens may help the body build an effective immune response to kill tumor cells. Sotorasib and adagrasibare in a class of medications called kinase inhibitors. They work by blocking the signals that cause tumor cells to multiply. This helps to stop the spread of tumor cells. Giving CIMAvax-EGF with a KRAS G12C inhibitor may be effective for treating advanced, KRAS G12C mutated non small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To identify the 12-month progression free survival (PFS) of patients with advanced stage KRAS G12C mutated non small cell lung cancer (NSCLC) treated with Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine (CIMAvax-EGF) in combination with KRAS G12C inhibitor.
SECONDARY OBJECTIVE:
- To assess response rate, 6-month PFS, safety profile and overall survival of patients treated with the combination of CIMAvax-EGF and KRAS G12C inhibitor.
OUTLINE:
LOADING PHASE: Patients receive CIMAvax-EGF intramuscularly (IM) every 2 weeks for 4 doses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM every 4 weeks for a total of 1 year of treatment, in the absence of disease progression or unacceptable toxicity. Patients who remain on study beyond 12 months and with antibody titer ≥ 1:4000 at the end of the loading phase may receive CIMAvax-EGF IM every 2 months as long as titer levels continue to be maintained > 1:4000. After the first 6 months of alternate dosing, may receive CIMAvax-EGF IM every 3 months in the absence of disease progression or unacceptable toxicity.
Patients also receive sotorasib orally (PO) once daily (QD) or adagrasib PO twice daily (BID) per their physician choice on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo magnetic resonance imaging (MRI) at baseline and as clinically indicated and undergo computed tomography (CT) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 30 days for 120 days then every 3 months thereafter.
- Conditions
- Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Being tested
- Adagrasib, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdagrasibDrug
Also called KRAS G12C Inhibitor MRTX849, Krazati, MRTX 849, MRTX-849
Given PO
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Recombinant Human EGF-rP64K/Montanide ISA 51 VaccineBiological
Also called Center of Molecular Immunology (CIMA) Epidermal Growth Factor (EGF) Vaccine, Center of Molecular Immunology Epidermal Growth Factor Vaccine, CimaVax, CIMAvax EGF
Given IM
SotorasibDrug
Also called AMG 510, AMG-510, AMG510, Lumakras
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CIMAvax-EGF and KRAS G12C inhibitor) | Experimental | LOADING PHASE: Patients receive CIMAvax-EGF IM every 2 weeks for 4 doses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM every 4 weeks for a total of 1 year of treatment, in the absence of disease progression or unacceptable toxicity. Patients who remain on study beyond 12 months and with antibody titer ≥ 1:4000 at the end of the loading phase may receive CIMAvax-EGF IM every 2 months as long as titer levels continue to be maintained > 1:4000. After the first 6 months of alternate dosing, may receive CIMAvax-EGF IM every 3 months in the absence of disease progression or unacceptable toxicity.
Patients also receive sotorasib PO QD or adagrasib PO BID per their physician choice on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo MRI at baseline and as clinically indicated and undergo CT scan and blood sample collection throughout the study. Receives: Drug: Adagrasib; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine; Drug: Sotorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Will be calculated as the binomial proportion of patients who have not experienced a PFS event within 12 months of study enrollment. The 95% confidence intervals for 12-month PFS will be estimated using Jeffreys method.
Measured: From enrollment to the loading phase and documentation of disease progression or death, at 12 months
Dose limiting toxicity (Safety lead in)
Measured: Up to 3 years
Secondary outcomes (5)
Objective response rate (ORR)
Will be based on Response Evaluation Criteria in Solid Tumors. Will be calculated as the number of patients with a confirmed complete or partial response divided by the total number of patients. The 95% confidence intervals for ORR will be estimated using Jeffreys method.
Measured: Up to 3 years
Progression free survival (PFS)
Will also be presented using Kaplan-Meier product limit estimators.
Measured: From enrollment to the loading phase and documentation of disease progression or death, at 6 months
Median PFS
Will also be presented using Kaplan-Meier product limit estimators.
Measured: From enrollment to the loading phase and documentation of disease progression or death, up to 3 years
Overall survival
Will also be presented using Kaplan-Meier product limit estimators.
Measured: From study enrollment to the Loading Phase and death from any cause, up to 3 years
Incidence of adverse events (AEs)
The maximum grade for each type of AEs will be recorded for each patient based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The frequency of AEs will be tabulated by maximum grade per event across all dose levels and cycles.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace K Dy, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543172
- Sponsor's protocol ID
- I-4697425
- Other IDs
- NCI-2026-02049, I-4697425
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of CIMAVAX-EGF in Combination With KRAS G12C Inhibitors as Treatment for Advanced Stage KRAS G12C Mutated NSCLC
- ClinicalTrials.gov ID
- NCT07543172
- Acronym / sponsor ID
- I-4697425
- Conditions
- Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 21 Apr 2026 (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 phase II trial tests how well giving CIMAvax-EGF with KRAS G12C inhibitor (sotorasib or adagrasib) for the treatment of patients with KRAS G12C mutated non small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Vaccines, such as CIMAvax-EGF, made from specific peptides or antigens may help the body build an effective immune response to kill tumor cells. Sotorasib and adagrasibare in a class of medications called kinase inhibitors. They work by blocking the signals that cause tumor cells to multiply. This helps to stop the spread of tumor cells. Giving CIMAvax-EGF with a KRAS G12C inhibitor may be effective for treating advanced, KRAS G12C mutated non small cell lung cancer.
Detailed description
PRIMARY OBJECTIVE:
- To identify the 12-month progression free survival (PFS) of patients with advanced stage KRAS G12C mutated non small cell lung cancer (NSCLC) treated with Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine (CIMAvax-EGF) in combination with KRAS G12C inhibitor.
SECONDARY OBJECTIVE:
- To assess response rate, 6-month PFS, safety profile and overall survival of patients treated with the combination of CIMAvax-EGF and KRAS G12C inhibitor.
OUTLINE:
LOADING PHASE: Patients receive CIMAvax-EGF intramuscularly (IM) every 2 weeks for 4 doses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM every 4 weeks for a total of 1 year of treatment, in the absence of disease progression or unacceptable toxicity. Patients who remain on study beyond 12 months and with antibody titer ≥ 1:4000 at the end of the loading phase may receive CIMAvax-EGF IM every 2 months as long as titer levels continue to be maintained > 1:4000. After the first 6 months of alternate dosing, may receive CIMAvax-EGF IM every 3 months in the absence of disease progression or unacceptable toxicity.
Patients also receive sotorasib orally (PO) once daily (QD) or adagrasib PO twice daily (BID) per their physician choice on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo magnetic resonance imaging (MRI) at baseline and as clinically indicated and undergo computed tomography (CT) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 30 days for 120 days then every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (CIMAvax-EGF and KRAS G12C inhibitor) | Experimental | Drug: Adagrasib, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine, Drug: SotorasibLOADING PHASE: Patients receive CIMAvax-EGF IM every 2 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM every 4 weeks for a total of 1 year of treatment, in the absence of disease progression or unacceptable toxicity. Patients who remain on study beyond 12 months and with antibody titer ≥ 1:4000 at the end of the loading phase may receive CIMAvax-EGF IM every 2 months as long as titer levels continue to be maintained > 1:4000. After the first 6 months of alternate dosing, may receive CIMAvax-EGF IM every 3 months in the absence of disease progression or unacceptable toxicity. Patients also receive sotorasib PO QD or adagrasib PO BID per their physician choice on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline and as clinically indicated and undergo CT scan and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years old
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at the time of study treatment initiation
- Have pathologically (cytology or histology) confirmed diagnosis of NSCLC. Non-small cell carcinoma diagnosis without specific tissue of origin confirmation may be eligible with approval from primary investigator (PI) review
- Must be eligible for treatment with standard of care KRAS G12C inhibitors
- Documented KRAS G12C mutation. Testing will occur by standard of care next generation sequencing (NGS) testing and results will be available in the medical record
Key exclusion criteria (13 listed)
- Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug (see exception allowed for #2)
- Previously treated with KRAS G12C inhibitor (exception allowed for patients who started KRAS G12C inhibitor within 4 weeks of study enrollment)
- Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities
- Active/untreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 2 weeks prior to first administration of study drug. Previously treated brain metastasis allowed as long as not requiring steroids
- Leptomeningeal involvement regardless of treatment status
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 |
|---|---|---|
| AdagrasibAlso: KRAS G12C Inhibitor MRTX849, Krazati, MRTX 849, MRTX-849Given PO | Drug | Treatment (CIMAvax-EGF and KRAS G12C inhibitor) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (CIMAvax-EGF and KRAS G12C inhibitor) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan | Procedure or surgery | Treatment (CIMAvax-EGF and KRAS G12C inhibitor) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (CIMAvax-EGF and KRAS G12C inhibitor) |
| Recombinant Human EGF-rP64K/Montanide ISA 51 VaccineAlso: Center of Molecular Immunology (CIMA) Epidermal Growth Factor (EGF) Vaccine, Center of Molecular Immunology Epidermal Growth Factor Vaccine, CimaVax, CIMAvax EGFGiven IM | Biological | Treatment (CIMAvax-EGF and KRAS G12C inhibitor) |
| SotorasibAlso: AMG 510, AMG-510, AMG510, LumakrasGiven PO | Drug | Treatment (CIMAvax-EGF and KRAS G12C inhibitor) |
Primary outcome
Progression free survival (PFS)
Time frame: From enrollment to the loading phase and documentation of disease progression or death, at 12 months
Will be calculated as the binomial proportion of patients who have not experienced a PFS event within 12 months of study enrollment. The 95% confidence intervals for 12-month PFS will be estimated using Jeffreys method.
Dose limiting toxicity (Safety lead in)
Time frame: Up to 3 years
5 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 3 years
Progression free survival (PFS)
Time frame: From enrollment to the loading phase and documentation of disease progression or death, at 6 months
Median PFS
Time frame: From enrollment to the loading phase and documentation of disease progression or death, up to 3 years
Overall survival
Time frame: From study enrollment to the Loading Phase and death from any cause, up to 3 years
Incidence of adverse events (AEs)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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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.
Grace K Dy principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adagrasib, Biospecimen Collection and Computed Tomography in people with Advanced Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, run by Roswell Park Cancer Institute 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 16 inclusion and 13 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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: From enrollment to the loading phase and documentation of disease progression or death, at 12 months). 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 2 Sep 2026.