Hepatocellular CarcinomaPhase 2NCT05620771
Therasphere® and Systemic Therapy for Patients With Hepatocellular Carcinoma That is High-risk
A Phase 2 study testing Y90 + Atezolizumab and Bevacizumab and Y90 + TKI in people with Hepatocellular Carcinoma, run by Northwestern University at 7 sites in United States.
Trial summary
The purpose of this research is to compare progression free survival between two available systemic therapies - immunotherapy and tyrosine kinase inhibitors - after Therasphere® (yttrium-90) treatment in adult patients with advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Y90 + Atezolizumab and Bevacizumab and Y90 + TKI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Nov 2022to 1 Jul 2040
- 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
- 3.1.1 Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD) guidelines with a Childs-Pugh score of A or B7 [Appendix 5] NOTE: If the patient does not have histological confirmation of disease by biopsy, diagnosis of HCC must be documented with approval by a tumor board or other multidisciplinary conference. Please refer to the appropriate source documents.
- 3.1.2 Patients must have at least 1 lesion that is measurable using RECIST guidelines. NOTE: A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST, and has clearly progressed.
- 3.1.3 Patients may be treatment -naïve or have received any number of prior therapies. NOTE: Prior cancer targeted immunotherapy for any other cancer is contraindicated and not permitted.
- 3.1.4 Adults ≥18 years old of either gender are eligible.
- 3.1.5 Patients must exhibit an ECOG performance status of 0, 1, or 2 [Appendix 1]
- 3.1.6 Patients must have adequate organ function prior to registration as determined by: Hemoglobin (HgB) ≥ 8.5 g/dL (without the use of growth factors, transfusion permitted), Absolute Neutrophil Count (ANC) ≥ 50 x 109/L (without use of growth factors [i.e., IL-11], transfusion permitted to achieve this value), Prothrombin time (PT)/ International normalized ratio ≤ 2.3 or PT ≤ 6 seconds above control, Calculated creatinine clearance (CrCl) or 24-hour urine CrCl > 30 mL/min, Serum Bilirubin ≤ 3 times the upper limit of normal (ULN), AST 10X ULN, ALT 10X ULN
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- 3.1.7 Females of childbearing potential (FOCBP), and non-sterilized males who are sexually active must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed in Appendix 3. They must also refrain from egg and/or sperm cell donation and breastfeeding for 90 days after the final dose of investigational product(s). FOCBP are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause) FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment. Men who are sexually active with FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment.
- 3.1.8 FOCBP must have a negative pregnancy test (Serum or urine pregnancy test per site investigator discretion) prior to registration.
- 3.1.9 Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.
Who cannot join
- 3.2.1 Patients who are concurrently enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study.
- 3.2.2 Patients who are receiving any other investigational agents within 28 days of registration.
- 3.2.3 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y-90, PD-1 \&PD-L1 antagonists and TKI's. Note: Patients must not have a history of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of initiation of supportive care) to any unknown allergens or any components of the systemic therapy
- 3.2.4 Patients must not have had prior treatment any PDL1 or PD-1 antagonists.
- 3.2.5 Patients who have known additional malignancy that progressed or required treatment within the last 3 years. Note: Exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years.
- 3.2. 6 Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded.
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- 3.2.7 Patients with renal failure currently requiring dialysis of any kind.
- 3.2.8 Patients with untreated central nervous system (CNS) metastatic disease (including spinal cord and leptomeningeal disease) are excluded. Note: Subjects with previously treated CNS metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management are permitted to enroll.
- 3.2.9 Patients with chronic Hepatitis B with evidence of ongoing viral replication (detectable HBsAg, HBeAg, or HBV DNA). They must have HBV DNA viral load >100 IU/mL at screening. Note: One viral load is sufficient as long as it meets this criterion. However, patient may need another viral load done per treating physician's discretion to confirm eligibility. Note:. Both HBeAg positive and negative patients will are eligible.
- 3.2.10 Patients with a known history of Human immunodeficiency virus(HIV) who are not on effective anti-retroviral therapy.
- 3.2.11 Patients with a known history of hepatitis C virus (HCV) infection who have not been treated and cured. Note: For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral.
- 3.2.12 Patients receiving any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 28 days of registration. Note: Prior cancer immunotherapy for any other cancer is not permitted. Note: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
- 3.2.13 Patients who have unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v 5 [Appendix 6] Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Note: Subjects with any grade irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss) after consultation with the PI and NU QAM.
- 3.2.14 Patients receiving radiation therapy within 14 days of registration.
- 3.2.15 Patients receiving live vaccines within 28 days of study registration.
- 3.2.16 No systemic glucocorticoids will be permitted within 48 hours prior to study registration. Note: Topical steroids, bronchodilators and local steroid injections are permitted if clinically required.
- 3.2.17 Patients with cardiac disease defined as one of the following are not eligible: Congestive heart failure > class II NYHA.[Appendix 4], Unstable angina (anginal symptoms at rest) or new onset angina (began within the last 90 days ), Myocardial infarction within the past 180 days.
- 3.2.18 Patients who have had major surgery within 4 weeks prior to registration.
- 3.2.19 Patients with prior transplant of any kind
- 3.2.20 Patients who are pregnant or nursing.
- 3.2.21 Patients who have an uncontrolled intercurrent illness.
- 3.2.22 Active alcohol use, drug use, or a psychiatric disease that would, in the opinion of the PI or a subinvestigator (sub-I), prevent the subject from complying with the study protocol and/or endanger the subject during their participation in the study.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Aparna Kalyan, MD, 312-472-1234
Aparna Kalyan, MD
- Recruiting
Northwestern Medicine Kishwaukee Hospital
DeKalb, Illinois, 60115
Aparna Kalyan, MD, 312-472-1234, cancer@northwestern.edu
- Recruiting
Northwestern Medicine Delnor Hospital
Geneva, Illinois, 60134
Aparna Kalyan, MD, 312-472-1234, cancer@northwestern.edu
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Aparna Kalyan, 312-472-1234, cancer@northwestern.edu
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Aparna Kalyan, MD, 312-472-1234, cancer@northwestern.edu
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Aparna Kalyan, 312-472-1234, cancer@northwestern.edu
- Recruiting
Northwestern Medicine Warrenville
Warrenville, Illinois, 60555
Aparna Kalyan, MD, 312-472-1234, cancer@northwestern.edu
About this study
Official title: Phase II Study Therasphere® (Yttrium-90) in Combination With Systemic Therapy in Patients With High-risk Hepatocellular Carcinoma
The purpose of this research is to compare progression free survival between two available systemic therapies - immunotherapy and tyrosine kinase inhibitors - after Therasphere® (yttrium-90) treatment in adult patients with advanced hepatocellular carcinoma. The immunotherapy consists of a standard-of-care treatment with Atezolizumab and Bevacizumab. Treatment with tyrosine kinase inhibitors consists of standard-of-care Lenvatinib or Cabozantinib.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare Progression Free Survival (PFS) in patients with advanced HCC who receive Y90 followed by immunotherapy (atezolizumab + bevacizumab, Arm A) or Y90 followed by TKI treatment ( lenvatinib or cabozantinib, Arm B). For ARM B, [patients will receive Lenvatinib. If they have prior history of treatment with Lenvatinib, then can be given Cabozantinib]..
SECONDARY OBJECTIVES:
- To compare the Time to Progression (TTP) in patients with advanced HCC who receive Immunotherapy combination compared to TKI following Y90.
II. To compare the Objective Response Rate (ORR) as assessed by RECIST v1.1 in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90.
III. To compare the Duration of Response (DOR) in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90.
IV. To compare the Clinical Benefit Rates (CBR) [CR, PR,SD] as assessed by RECIST v1.1 in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90.
- To compare the Overall Survival (OS) in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90.
VI. To compare the safety and tolerability of patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90, as defined by NCI CTCAEv5.
OUTLINE:
Patients will first be treated one time with liver directed therapy, Therasphere® (Y-90), following institutional procedures. After completion of Y- 90, patients will have some recovery time (14-21 days) prior to starting systemic therapy.
Patients will be followed up for 2 years after completion of study treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Y90 + Atezolizumab and Bevacizumab, Y90 + TKI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y90 + Atezolizumab and BevacizumabDrug
Patients will receive Durvalumumab + Tremelimumab if Bevacizumab is contraindicated. Patients should begin systemic therapy anytime within 90 days after completion of Y-90 treatment. Treatment will continue until disease progression (clinical or radiological) or unacceptable toxicity/death. Patients will be continued on therapy till either progression is noted (clinical and/or radiological) or if patient is not tolerating therapy. However, there is the possibility of treatment beyond progression per PI discretion.
Y90 + TKIDrug
Patients should begin systemic therapy anytime within 90 days after completion of Y-90 treatment. Treatment will continue until disease progression (clinical or radiological) or unacceptable toxicity/death. Patients will be continued on therapy till either progression is noted (clinical and/or radiological) or if patient is not tolerating therapy. However, there is the possibility of treatment beyond progression per PI discretion.
| Study group | Role | What they receive |
|---|---|---|
| Y90 + Atezolizumab and Bevacizumab | Experimental | Not described Receives: Drug: Y90 + Atezolizumab and Bevacizumab |
| Y90 + TKI | Experimental | Not described Receives: Drug: Y90 + TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
To compare PFS by RECIST v1.1 criteria, with Y90 followed by immunotherapy (atezolizumab + bevacizumab, Arm A) or Y90 followed by TKI treatment (lenvatinib or cabozantinib, Arm B). Progression is defined as either radiological progression (with MRI or CT scan) OR clinical progression.
Measured: Up to 2 years
Secondary outcomes (6)
Time to Progression (TTP)
To compare the TTP in patients with advanced HCC who receive Immunotherapy combination compared to TKI following Y90. The TTP will be measured as the time of the last available radiographical or clinical disease assessment documenting lack of disease progression.
Measured: Up to 2 years
Objective Response Rate (ORR)
To compare the ORR as assessed by RECIST v1.1 in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90. This will be assessed based on imaging.
Measured: Up to 2 years
Duration of Response (DOR)
To compare the DOR in patients by RECIST v1.1 criteria and is defined as either radiological progression (with MRI or CT scan) OR clinical progression.
Measured: Up to 2 years
Clinical Benefit Rates (CBR)
To compare the CBR as assessed by RECIST v1.1, CBR is defined as the percentage of patients with best response documented as Complete Response (CR), plus those with Partial Response (PR) plus those with Stable Disease (SD).
Measured: Up to 2 years
Overall Survival (OS)
OS is defined from the date of randomization to the study until the date of death from any cause for up to 2 years.
Measured: Up to 2 years
Adverse Events
To compare the safety and tolerability of patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90, as defined by NCI CTCAEv5.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start30 Nov 2022
- Primary completion1 Jul 2040 (estimated)
- Study completion1 Jul 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aparna Kalyan, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620771
- Sponsor's protocol ID
- NU 22I07
- Other IDs
- NCI-2022-09476, P30CA060553, NU 22I07
- Status last verified
- May 2026
- First submitted
- 11 Nov 2022
- Last updated
- 26 May 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Therasphere® (Yttrium-90) in Combination With Systemic Therapy in Patients With High-risk Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05620771
- Acronym / sponsor ID
- NU 22I07
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Jul 2040 (estimated)
- Study completion
- 1 Jul 2040 (estimated)
- First posted
- 17 Nov 2022 (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.
The purpose of this research is to compare progression free survival between two available systemic therapies - immunotherapy and tyrosine kinase inhibitors - after Therasphere® (yttrium-90) treatment in adult patients with advanced hepatocellular carcinoma. The immunotherapy consists of a standard-of-care treatment with Atezolizumab and Bevacizumab. Treatment with tyrosine kinase inhibitors consists of standard-of-care Lenvatinib or Cabozantinib.
Detailed description
PRIMARY OBJECTIVES:
- To compare Progression Free Survival (PFS) in patients with advanced HCC who receive Y90 followed by immunotherapy (atezolizumab + bevacizumab, Arm A) or Y90 followed by TKI treatment ( lenvatinib or cabozantinib, Arm B). For ARM B, [patients will receive Lenvatinib. If they have prior history of treatment with Lenvatinib, then can be given Cabozantinib]..
SECONDARY OBJECTIVES:
- To compare the Time to Progression (TTP) in patients with advanced HCC who receive Immunotherapy combination compared to TKI following Y90.
II. To compare the Objective Response Rate (ORR) as assessed by RECIST v1.1 in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90.
III. To compare the Duration of Response (DOR) in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90.
IV. To compare the Clinical Benefit Rates (CBR) [CR, PR,SD] as assessed by RECIST v1.1 in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90.
- To compare the Overall Survival (OS) in patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90.
VI. To compare the safety and tolerability of patients with advanced HCC who receive immunotherapy combination and those who receive TKI treatment after Y90, as defined by NCI CTCAEv5.
OUTLINE:
Patients will first be treated one time with liver directed therapy, Therasphere® (Y-90), following institutional procedures. After completion of Y- 90, patients will have some recovery time (14-21 days) prior to starting systemic therapy.
Patients will be followed up for 2 years after completion of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y90 + Atezolizumab and Bevacizumab | Experimental | Drug: Y90 + Atezolizumab and Bevacizumab |
| Y90 + TKI | Experimental | Drug: Y90 + TKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 3.1.1 Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD) guidelines with a Childs-Pugh score of A or B7 [Appendix 5] NOTE: If the patient does not have histological confirmation of disease by biopsy, diagnosis of HCC must be documented with approval by a tumor board or other multidisciplinary conference. Please refer to the appropriate source documents.
- 3.1.2 Patients must have at least 1 lesion that is measurable using RECIST guidelines. NOTE: A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST, and has clearly progressed.
- 3.1.3 Patients may be treatment -naïve or have received any number of prior therapies. NOTE: Prior cancer targeted immunotherapy for any other cancer is contraindicated and not permitted.
- 3.1.4 Adults ≥18 years old of either gender are eligible.
- 3.1.5 Patients must exhibit an ECOG performance status of 0, 1, or 2 [Appendix 1]
Key exclusion criteria (22 listed)
- 3.2.1 Patients who are concurrently enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study.
- 3.2.2 Patients who are receiving any other investigational agents within 28 days of registration.
- 3.2.3 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y-90, PD-1 \&PD-L1 antagonists and TKI's. Note: Patients must not have a history of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of initiation of supportive care) to any unknown allergens or any components of the systemic therapy
- 3.2.4 Patients must not have had prior treatment any PDL1 or PD-1 antagonists.
- 3.2.5 Patients who have known additional malignancy that progressed or required treatment within the last 3 years. Note: Exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years.
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 |
|---|---|---|
| Y90 + Atezolizumab and BevacizumabPatients will receive Durvalumumab + Tremelimumab if Bevacizumab is contraindicated. Patients should begin systemic therapy anytime within 90 days after completion of Y-90 treatment. Treatment will continue until disease progression (clinical or radiological) or unacceptable toxicity/death. Patients will be continued on therapy till either progression is noted (clinical and/or radiological) or if patient is not tolerating therapy. However, there is the possibility of treatment beyond progression per PI discretion. | Drug | Y90 + Atezolizumab and Bevacizumab |
| Y90 + TKIPatients should begin systemic therapy anytime within 90 days after completion of Y-90 treatment. Treatment will continue until disease progression (clinical or radiological) or unacceptable toxicity/death. Patients will be continued on therapy till either progression is noted (clinical and/or radiological) or if patient is not tolerating therapy. However, there is the possibility of treatment beyond progression per PI discretion. | Drug | Y90 + TKI |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 2 years
To compare PFS by RECIST v1.1 criteria, with Y90 followed by immunotherapy (atezolizumab + bevacizumab, Arm A) or Y90 followed by TKI treatment (lenvatinib or cabozantinib, Arm B). Progression is defined as either radiological progression (with MRI or CT scan) OR clinical progression.
6 secondary outcomes
Time to Progression (TTP)
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Clinical Benefit Rates (CBR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Adverse Events
Time frame: Up to 2 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 26 May 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.
Aparna Kalyan, MD principal investigator
Northwestern University
7 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 Y90 + Atezolizumab and Bevacizumab and Y90 + TKI in people with Hepatocellular Carcinoma, run by Northwestern University at 7 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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Contact Study Coordinator (3126951301, cancer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to 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 26 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.