MelanomaPhase 2iPREDICTNCT05013099
Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies
A Phase 2 study testing zirconium Zr 89 crefmirlimab berdoxam in people with Melanoma and Merkel Cell Carcinoma, Unspecified, run by ImaginAb, Inc. at 16 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Merkel Cell Carcinoma, Unspecified, Renal Cell Carcinoma
- What is being tested?
- zirconium Zr 89 crefmirlimab berdoxam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 9 Dec 2021to Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for enrollment in the study if they meet ONE criteria a, b or c in point 1 and ALL the criteria in points 2-9.
- Subjects must meet ONE of the criteria a, b or c below:
- For enrollment into Cohort A: Subjects with histologically confirmed advanced or metastatic non-uveal/non-mucosal melanoma or merkel cell carcinoma (MCPyV positive and negative) who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment.
- For enrollment into Cohort B: Subjects with histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma or Renal Cell Carcinoma with sarcomatoid features (regardless of subtype) as defined on pathologic examination by a component of clear cell or sarcomatoid, who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone or IOT in combination with VEGFR-directed or tyrosine kinase inhibitor (not to include cytotoxic chemotherapy) as first or second line treatment
- For enrollment into Cohort C: Subjects with histologically confirmed advanced or metastatic non-small cell lung cancer without non-smoker/driver mutations who are not amenable to surgical cure, and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment as per the label/prescribing information at the physicians discretion.
- Patients with driver mutations that are expected to show significant benefit from first line checkpoint inhibiter treatment (such as KRAS G12C mutations) are eligible if all other I/E criteria are met
Show all 15Show fewer
- Subjects must meet All of the criteria 2-9 below:
- At least 1 RECIST 1.1-measurable. non-irradiated, non-osseous (unless there is an associated measurable soft-tissue component) lesion documented on intravenous (IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to first zirconium Zr 89 crefmirlimab berdoxam administration.
- Has an adequate amount of time between their prior treatment/procedure and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months.
- Meeting all clinical safety lab values per institution's SOC, or investigator's discretion, for subjects receiving cancer treatment.
- Male or female age ≥18 years.
- Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board (IRB) approved informed consent form.
- Willingness and ability to comply with all protocol required procedures.
- For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
Who cannot join
- Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
- Bone-only disease without a measurable soft tissue component on conventional imaging (MRI, PET, CT).
- Subjects with skin-only (cutaneous) lesions will be excluded from the tumor biopsy assessment.
- Serious nonmalignant disease, additional active malignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- Subjects with splenic dysfunction or who are status post splenectomy. Post-splenectomy subjects who develop an accessory spleen with clinical and radiographic evidence of splenic function will be allowed with prior approval from the Sponsor.
- Corticosteroid therapy is prohibited if used for the treatment of inflammatory or autoimmune conditions. Patients with adrenal insufficiency from prior surgery or immunotherapy toxicity may be on standard chronic replacement doses of hydrocortisone that also require sporadic use of stress doses of steroid .
- Pregnant women or nursing mothers.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United States6 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
City of Hope
Duarte, California, 91010
CARTI Cancer Center
Little Rock, Arkansas, 72205
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Providence Saint John's Cancer Institute
Santa Monica, California, 90404
University of Washington
Seattle, Washington, 98109
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Olivia Newton-John Cancer Research Insititute
Heidelberg, Victoria, 3084
Macquarie University Hospital
Macquarie Park, New South Wales, 2109
Peter MacCallum Cancer Centre
Melbourne, Victoria
Princess Alexandra Hospital
Woolloongabba, Queensland
Netherlands2 sites
Leiden University Medical Center
Leiden
Radboud University Medical Center
Nijmegen, Gelderland, 6525
United Kingdom1 site
Northern Centre for Cancer Care and Newcastle University
Newcastle upon Tyne
About this study
Official title: A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies, Scheduled to Receive Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy
The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.
- Conditions
- Melanoma, Merkel Cell Carcinoma, Unspecified, Renal Cell Carcinoma, Non Small Cell Lung Cancer
- Being tested
- zirconium Zr 89 crefmirlimab berdoxam
- Medical subject headings
- Melanoma, Carcinoma, Merkel Cell, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zirconium Zr 89 crefmirlimab berdoxamBiological
Also called 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C
Up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with melanoma, Merkel cell, renal cell, or NSCLC | Experimental | Eligible subjects will receive up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First scan within 14 days prior to the onset of IOT, and a second scan 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion. Receives: Biological: zirconium Zr 89 crefmirlimab berdoxam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
Measured: Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.
Secondary outcomes (24)
Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI)
Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
Measured: Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.
Incidence and severity of AEs
Incidence and severity of AEs
Measured: Up to 48 weeks or end of treatment.
Incidence and severity of infusion or injection reactions
Incidence and severity of infusion or injection reactions reported during or shortly after administration of the investigational product.
Measured: 33 days post infusion
Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
Measured: Up to 48 weeks or end of treatment
12-lead ECG ventricular rate (bpm)
Ventricular rate (bpm) will be recorded from the 12-lead ECG
Measured: baseline to 48 weeks or end of study
12-lead ECG PR interval (msec)
PR interval (msec) will be recorded from the 12-lead ECG
Measured: baseline to 48 weeks or end of study
12-lead ECG QRS interval (msec)
QRS interval (msec) will be recorded from the 12-lead ECG
Measured: baseline to 48 weeks or end of study
12-lead ECG QT interval (msec)
QT interval (msec) will be recorded from the 12-lead ECG
Measured: baseline to 48 weeks or end of study
12-lead ECG QTc interval (msec)
QTc interval (msec) will be recorded from the 12-lead ECG
Measured: baseline to 48 weeks or end of study
12-lead ECG Overall Result
Investigator's overall assessment of the ECG reading will be recorded as normal or abnormal. If abnormal, as either "not clinically significant" or "clinically significant"
Measured: baseline to 48 weeks or end of study
Anti-drug antibody
Detection of anti-drug antibodies
Measured: baseline to 48 weeks or end of study
Change in blood AST levels (U/L) from baseline.
Blood AST levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood ALT levels (U/L) from baseline.
Blood ALT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood ALP levels (U/L) from baseline.
Blood ALP levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood bilirubin levels (mg/dL) from baseline.
Blood bilirubin levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood LDH levels (U/L) from baseline.
Blood LDH levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood BUN levels (mg/dL) from baseline.
Blood BUN levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood GGT levels (U/L) from baseline.
Blood GGT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in serum creatinine levels (mg/dL) from baseline.
Serum creatinine levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood uric acid levels (mg/dL) from baseline.
Blood uric acid levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood sodium levels (mmol/L) from baseline.
Blood sodium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood potassium levels (mmol/L) from baseline.
Blood potassium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood chloride levels (mmol/L) from baseline.
Blood chloride (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Change in blood glucose levels (mg/dL) from baseline.
Blood glucose (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Measured: Baseline through 48 weeks or end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start9 Dec 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImaginAb, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Margolin, MD, Principal investigator, Providence Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013099
- Sponsor's protocol ID
- IAB-CD8-203
- Acronym
- iPREDICT
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2021
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies, Scheduled to Receive Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy
- ClinicalTrials.gov ID
- NCT05013099
- Acronym / sponsor ID
- iPREDICT / IAB-CD8-203
- Conditions
- Melanoma, Merkel Cell Carcinoma, Unspecified, Renal Cell Carcinoma, Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- ImaginAb, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Aug 2021 (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 study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with melanoma, Merkel cell, renal cell, or NSCLC | Experimental | Biological: zirconium Zr 89 crefmirlimab berdoxamEligible subjects will receive up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First scan within 14 days prior to the onset of IOT, and a second scan 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects will be eligible for enrollment in the study if they meet ONE criteria a, b or c in point 1 and ALL the criteria in points 2-9.
Key exclusion criteria (7 listed)
- Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
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 |
|---|---|---|
| zirconium Zr 89 crefmirlimab berdoxamAlso: 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2CUp to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion. | Biological | Subjects with melanoma, Merkel cell, renal cell, or NSCLC |
Primary outcome
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)
Time frame: Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
24 secondary outcomes
Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI)
Time frame: Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.
Incidence and severity of AEs
Time frame: Up to 48 weeks or end of treatment.
Incidence and severity of infusion or injection reactions
Time frame: 33 days post infusion
Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
Time frame: Up to 48 weeks or end of treatment
12-lead ECG ventricular rate (bpm)
Time frame: baseline to 48 weeks or end of study
12-lead ECG PR interval (msec)
Time frame: baseline to 48 weeks or end of study
12-lead ECG QRS interval (msec)
Time frame: baseline to 48 weeks or end of study
12-lead ECG QT interval (msec)
Time frame: baseline to 48 weeks or end of study
12-lead ECG QTc interval (msec)
Time frame: baseline to 48 weeks or end of study
12-lead ECG Overall Result
Time frame: baseline to 48 weeks or end of study
Anti-drug antibody
Time frame: baseline to 48 weeks or end of study
Change in blood AST levels (U/L) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood ALT levels (U/L) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood ALP levels (U/L) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood bilirubin levels (mg/dL) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood LDH levels (U/L) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood BUN levels (mg/dL) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood GGT levels (U/L) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in serum creatinine levels (mg/dL) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood uric acid levels (mg/dL) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood sodium levels (mmol/L) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood potassium levels (mmol/L) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood chloride levels (mmol/L) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood glucose levels (mg/dL) from baseline.
Time frame: Baseline through 48 weeks or end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Margolin, MD principal investigator
Providence Saint John's Cancer Institute
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zirconium Zr 89 crefmirlimab berdoxam in people with Melanoma and Merkel Cell Carcinoma, Unspecified, run by ImaginAb, Inc. at 16 sites in 6 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 15 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, Netherlands, Belgium, Switzerland and 1 more country. 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?
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?
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT) (time frame: Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.). 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 22 Jul 2024.