Metastatic Renal Cell CarcinomaPhase 2CYTOSHRINKNCT04090710
SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
A Phase 2 study testing Ipilimumab/ Nivolumab and SBRT + Ipilimumab/Nivolumab in people with Metastatic Renal Cell Carcinoma, run by Ontario Clinical Oncology Group (OCOG) at 7 sites in 2 countries.
Trial summary
This trial will evaluate the addition of cytoreductive stereotactic body radiation therapy (SBRT) to standard of care combination ipilimumab and nivolumab (I/N) versus I/N alone for the treatment of metastatic kidney cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Ipilimumab/ Nivolumab and SBRT + Ipilimumab/Nivolumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 29 Jan 2020to 30 Jun 2026
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy proven renal cell carcinoma of any histology.
- Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening.
- Intermediate/poor risk disease based on IMDC criteria (see Appendix II).
- Primary kidney lesion amenable to SBRT.
- Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph.
Who cannot join
- A maximum primary renal lesion size of 20 cm or greater.
- Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient refusal must be documented).
- Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma.
- Previous abdominal radiation precluding SBRT.
- Kanofsky Performance (KPS) score below 60 (see Appendix III).
- History of auto-immune disorder precluding treatment with ipilimumab or nivolumab.
Show all 13Show fewer
- History of ataxia telangiectasia or other radiation sensitivity disorders.
- Chronic corticosteroid use or other chronic immune suppressive therapy. (Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses of prednisone ≤ 10 mg daily are permitted).
- Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician.
- Inability to lie flat for at least 30 minutes without moving.
- Pregnant or lactating women.
- Geographic inaccessibility for follow-up.
- Inability to provide informed consent.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada6 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre
Hamilton, Ontario
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G1G3
London Regional Cancer Centre
London, Ontario, N2G1G3
The Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H8L6
Sunnybrook Health Sciences Centre- Odette Cancer Centre
Toronto, Ontario, M4N3M5
About this study
Official title: Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
This trial will evaluate the addition of cytoreductive stereotactic body radiation therapy (SBRT) to standard of care combination ipilimumab and nivolumab (I/N) versus I/N alone for the treatment of metastatic kidney cancer.
Read the detailed description
This is a multi-centre, open label, phase II randomized clinical trial evaluating SBRT as upfront cytoreductive therapy to the primary renal mass along with combination I/N therapy in patients with intermediate/poor risk mRCC who are not candidates for cytoreductive nephrectomy. Eligible and consenting, newly diagnosed and histologically confirmed intermediate/poor risk mRCC patients based on IMDC criteria with primary disease in-situ will be randomized in a 2:1 fashion to either induction I/N followed by SBRT prior to the second cycle (experimental arm) versus I/N alone (standard arm). Patients will be stratified based on IMDC criteria (intermediate 1-2 versus poor 3-6).
- Standard Arm: induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.
- Experimental Arm: induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. Approximately one week following completion of SBRT, patients will start cycle 2 of I/N as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.
During treatment (standard and experimental arm) participants will be assessed for radiation toxicity and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months, for a period of 1 year. Progression free survival will be assessed by CT scan (chest; abdomen and pelvis), which is performed after the final I/N treatment and every 3 months as per standard of care. Participants will be followed for one additional year, seen at 18 and 24 months to assess survival. The planned sample size is 78 study participants.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Ipilimumab/ Nivolumab, SBRT + Ipilimumab/Nivolumab
- Keywords
- SBRT, Ipilimumab, Nivolumab
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipilimumab/ NivolumabDrug
Also called Yervoy/Opdivo
induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression
SBRT + Ipilimumab/NivolumabRadiation
SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care I/N alone | Active comparator | induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Receives: Drug: Ipilimumab/ Nivolumab |
| Standard of Care I/N plus primary disease SBRT | Experimental | induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. Approximately one week following completion of SBRT, patients will start cycle 2 of immunotherapy as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Receives: Radiation: SBRT + Ipilimumab/Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The primary outcome of this study is the hazard ratio for progression-free survival (PFS), defined from the date of randomization until the date of progression (PFS truncated at subsequent systemic therapy) as determined by RECIST 1.1, or death due to any cause, whichever comes first. All attempts will be made to follow-up patients for the primary outcome measure for at least one year, even if a patient stops treatment. Patients who do not have a primary outcome event at the time of analysis will be censored on the last date the patient can be confirmed as alive and progression-free.
Measured: 2 years
Secondary outcomes (9)
Subject safety
Incidence and attribution of deaths
Measured: Date of randomization until 1year post treatment
Overall Survival
- Overall survival, defined from the date of randomization to the date of death due to any cause. Patients with no known death date at the time of analysis will be censored on the last date they are confirmed alive.
Measured: 2 years
Objective response rate
- Objective response rate, which is defined as the proportion of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria.
Measured: 1 year
Quality of Life: EORTC QLQ-C30 questionnaire
- Quality of life, which will be evaluated using the EORTC QLQ-C30 questionnaire.
Measured: 1 year
Subject safety
Number of Adverse Events and Serious Adverse Events using NCI CTCAE v5.0
Measured: 1 Year
Ipilimumab/ Nivolumab drug tolerability
Ipilimumab/Nivolumab treatment discontinuation rates
Measured: From the date of randomization until date of first documented disease progression up to 1 year.
Ipilimumab/ Nivolumab drug tolerability
Number of doses of Ipilimumab/Nivolumab combination treatment
Measured: From the date of randomization until date of first documented disease progression, up to 1 year.
Ipilimumab/ Nivolumab drug tolerability
Number of Nivolumab maintenance doses
Measured: From the date of randomization until date of first documented disease progression, up to 1 year.
Ipilimumab/ Nivolumab drug tolerability
Time to treatment discontinuation from the date of randomization
Measured: From the date of randomization until date of first documented disease progression, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start29 Jan 2020
- Primary completion23 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible and consenting, newly diagnosed and histologically confirmed intermediate/poor risk metastatic renal cell carcinoma patients with primary disease in-situ will be randomized in a 2:1 fashion to either induction I/N followed by SBRT prior to the second cycle (experimental arm) versus I/N alone (standard arm). Patients will be stratified based on IMDC criteria (intermediate 1-2 versus poor 3-6).
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Aly-Khan Lalani, MD, Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090710
- Sponsor's protocol ID
- OCOG-2019-CYTOSHRINK
- Other IDs
- CA209-7DR
- Acronym
- CYTOSHRINK
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2019
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
- ClinicalTrials.gov ID
- NCT04090710
- Acronym / sponsor ID
- CYTOSHRINK / OCOG-2019-CYTOSHRINK
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- SBRT, Ipilimumab, Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Hamilton Health Sciences Corporation
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 16 Sep 2019 (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 trial will evaluate the addition of cytoreductive stereotactic body radiation therapy (SBRT) to standard of care combination ipilimumab and nivolumab (I/N) versus I/N alone for the treatment of metastatic kidney cancer.
Detailed description
This is a multi-centre, open label, phase II randomized clinical trial evaluating SBRT as upfront cytoreductive therapy to the primary renal mass along with combination I/N therapy in patients with intermediate/poor risk mRCC who are not candidates for cytoreductive nephrectomy. Eligible and consenting, newly diagnosed and histologically confirmed intermediate/poor risk mRCC patients based on IMDC criteria with primary disease in-situ will be randomized in a 2:1 fashion to either induction I/N followed by SBRT prior to the second cycle (experimental arm) versus I/N alone (standard arm). Patients will be stratified based on IMDC criteria (intermediate 1-2 versus poor 3-6).
- Standard Arm: induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.
- Experimental Arm: induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. Approximately one week following completion of SBRT, patients will start cycle 2 of I/N as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.
During treatment (standard and experimental arm) participants will be assessed for radiation toxicity and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months, for a period of 1 year. Progression free survival will be assessed by CT scan (chest; abdomen and pelvis), which is performed after the final I/N treatment and every 3 months as per standard of care. Participants will be followed for one additional year, seen at 18 and 24 months to assess survival. The planned sample size is 78 study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible and consenting, newly diagnosed and histologically confirmed intermediate/poor risk metastatic renal cell carcinoma patients with primary disease in-situ will be randomized in a 2:1 fashion to either induction I/N followed by SBRT prior to the second cycle (experimental arm) versus I/N alone (standard arm). Patients will be stratified based on IMDC criteria (intermediate 1-2 versus poor 3-6).
| Arm | Type | Receives |
|---|---|---|
| Standard of Care I/N alone | Active comparator | Drug: Ipilimumab/ Nivolumabinduction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. |
| Standard of Care I/N plus primary disease SBRT | Experimental | Radiation: SBRT + Ipilimumab/Nivolumabinduction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. Approximately one week following completion of SBRT, patients will start cycle 2 of immunotherapy as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy proven renal cell carcinoma of any histology.
- Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening.
- Intermediate/poor risk disease based on IMDC criteria (see Appendix II).
- Primary kidney lesion amenable to SBRT.
- Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph.
Key exclusion criteria (13 listed)
- A maximum primary renal lesion size of 20 cm or greater.
- Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient refusal must be documented).
- Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma.
- Previous abdominal radiation precluding SBRT.
- Kanofsky Performance (KPS) score below 60 (see Appendix III).
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 |
|---|---|---|
| Ipilimumab/ NivolumabAlso: Yervoy/Opdivoinduction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression | Drug | Standard of Care I/N alone |
| SBRT + Ipilimumab/NivolumabSBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. | Radiation | Standard of Care I/N plus primary disease SBRT |
Primary outcome
Progression free survival (PFS)
Time frame: 2 years
The primary outcome of this study is the hazard ratio for progression-free survival (PFS), defined from the date of randomization until the date of progression (PFS truncated at subsequent systemic therapy) as determined by RECIST 1.1, or death due to any cause, whichever comes first. All attempts will be made to follow-up patients for the primary outcome measure for at least one year, even if a patient stops treatment. Patients who do not have a primary outcome event at the time of analysis will be censored on the last date the patient can be confirmed as alive and progression-free.
9 secondary outcomes
Subject safety
Time frame: Date of randomization until 1year post treatment
Overall Survival
Time frame: 2 years
Objective response rate
Time frame: 1 year
Quality of Life: EORTC QLQ-C30 questionnaire
Time frame: 1 year
Subject safety
Time frame: 1 Year
Ipilimumab/ Nivolumab drug tolerability
Time frame: From the date of randomization until date of first documented disease progression up to 1 year.
Ipilimumab/ Nivolumab drug tolerability
Time frame: From the date of randomization until date of first documented disease progression, up to 1 year.
Ipilimumab/ Nivolumab drug tolerability
Time frame: From the date of randomization until date of first documented disease progression, up to 1 year.
Ipilimumab/ Nivolumab drug tolerability
Time frame: From the date of randomization until date of first documented disease progression, up to 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
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.
Aly-Khan Lalani, MD principal investigator
Juravinski Cancer Centre
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab/ Nivolumab and SBRT + Ipilimumab/Nivolumab in people with Metastatic Renal Cell Carcinoma, run by Ontario Clinical Oncology Group (OCOG) at 7 sites in 2 countries.
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 5 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: finished, as of the sponsor's last update on 28 Aug 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 Canada, Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.