Locally Advanced or Metastatic Urothelial Cell CarcinomaPhase 1/2FIERCE-22NCT03123055
A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
A Phase 1/2 study testing B-701 and Pembrolizumab in people with Locally Advanced or Metastatic Urothelial Cell Carcinoma and Urinary Bladder Disease, run by Rainier Therapeutics at 52 sites in 17 countries.
Trial summary
This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases
- What is being tested?
- B-701 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 52 sitesin 17 countries
- Study dates
- 20 Apr 2017to 1 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic transitional cell carcinoma of the urothelium, including of the urinary bladder, urethra, ureter, and/or renal pelvis. The diagnosis must be histologically or cytologically confirmed.
- Have progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- Have available archival tumor or be willing to undergo diagnostic biopsy at screening. Sample must be of suitable quality and quantity to satisfy group assignment and biomarker endpoints.
- Have measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
Who cannot join
- Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest CT scan.
- Prior therapy with an anti-programmed cell death 1 (PD-1) or anti-PD-Ligand 1 agent, or with an agent directed to another co-inhibitory T-cell receptor or FGFR inhibitor.
- Patients with autoimmune disease or medical conditions that required systemic corticosteroids (> 10 mg/day prednisone or its equivalent) or other immunosuppressive medications or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment. Note: Replacement therapy (e.g. physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Primary central nervous system (CNS) malignancy or CNS metastases.
- History of clinically significant coagulation or platelet disorder in the past 12 months.
Trial locations and contacts
52 sites in 17 countries.
52 sites in 17 countries
United States8 sites
Research Site
Cleveland, Ohio, 44195
Research Site
Fort Wayne, Indiana, 46845
Research Site
Germantown, Tennessee, 38138
Research Site
Greenbrae, California, 94904
Research Site
Houston, Texas, 77030
Research Site
Louisville, Kentucky, 40202
Research Site
Philadelphia, Pennsylvania, 19107
Washington University School of Medicine
St Louis, Missouri, 63110
Germany6 sites
Research Site
Dresden, 01307
Research Site
Frankfurt, 60488
Research Site
Heidelberg, 69120
Research Site
Kassel, 34125
Research Site
Munich, 81377
Research Site
Münster, 48149
Poland5 sites
Research Site
Katowice, 40-514
Research Site
Warsaw, 02-567
Research Site
Warsaw, 02-781
Research Site
Wieliszew, 05-135
Research Site
Wroclaw, 53-413
Serbia5 sites
Research Site
Belgrade, 11000
Research Site
Belgrade, 11070
Research Site
Kamenitz, 21204
Research Site
Kragujevac, 34000
Research Site
Niš, 18000
Spain5 sites
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Madrid, CA, 28050
Research Site
Madrid, 28034
Research Site
Madrid, 28041
South Korea4 sites
Research Site
Gwangju, 61469
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Belgium3 sites
Research Site
Brussels, 1000
Research Site
Leuven, 3000
Research Team
Yvoir, 5530
Russia3 sites
Research Site
Moscow, 125284
Research Site
Saint Petersburg, 197758
Research Team
Ufa, 450000
Turkey (Türkiye)2 sites
Research Site
Ankara, 06100
Research Site
Antalya, 07059
About this study
Official title: A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy
This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.
Read the detailed description
This is a Phase 1b/2 multi-center, open-label study to determine the safety, tolerability, and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor or FGFR inhibitor-targeted therapy. The study consists of 2 parts: a Phase 1b lead-in phase enrolling 6 to 18 subjects and a Phase 2 dose expansion phase enrolling up to a total of 74 subjects.
Subjects who discontinue B-701 (vofatamab) may continue on study and receive pembrolizumab alone until disease progression, death, withdrawal of patient consent, or study termination. Subjects who discontinue pembrolizumab may continue on study and receive B-701 (vofatamab) alone until disease progression, death, withdrawal of patient consent, or study termination.
- Conditions
- Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases
- Being tested
- B-701, Pembrolizumab
- Keywords
- Urothelial Cell Carcinoma, UCC, bladder cancer, B-701, FGFR3, invasive bladder cancer, Transitional Cell Carcinoma, TCC, second line therapy, monoclonal antibody, combination therapy, Phase 1b, pembrolizumab, checkpoint inhibitor, Phase 2, Urothelial Carcinoma, Vofatamab
- Medical subject headings
- Urinary Bladder Diseases, Urologic Diseases, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-701Drug
Also called MFGR1877S, Vofatamab
B-701 (vofatamab) is a human IgG1 monoclonal antibody that is highly specific for the FGFR3 receptor.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab is a humanized antibody used in cancer immunotherapy. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| B-701 (vofatamab) | Experimental | B-701 (vofatamab, 25 mg/kg) will be administered via IV infusion on Cycle 0 Day 1 for a single 14-day cycle. Receives: Drug: B-701 |
| B-701 (vofatamab) plus pembrolizumab | Experimental | B-701 (vofatamab, 25 mg/kg [or the recommended Phase 2 dose if different than 25 mg/kg]) plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks. Receives: Drug: B-701; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities Within a Period of 35 Days
Number of Participants with Dose Limiting Toxicities within a period of 35 days will be analyzed reviewing the aggregate of adverse events (AEs) and serious adverse events (SAEs) by the B-701 program Safety Oversight Committee and will result in a recommended Phase 2 dose. Six subjects at a time are enrolled and observed for 35 days after the initial dose. If 2 or more subjects experience a DLT that dose will be declared intolerable and de-escalation of the dose will occur.
Measured: 1 year
Number of Subjects Experiencing Adverse Events (AEs and SAEs)
Evaluate the safety and tolerability of B-701 (vofatamab) plus pembrolizumab in subjects with UCC as assessed by number of subjects experiencing adverse events (AEs and SAEs), physical examination findings, laboratory test results, and vital signs over time. This outcome is measured by a safety monitoring committee who regularly met and reviewed aggregate trends of reports AEs, lab ranges, physical exams etc. and determined if the drug was safe to continue.
Measured: 2.5 years
Efficacy of B-701 (Vofatamab) Plus Pembrolizumab Measured by ORR
Evaluate the efficacy of B-701 (vofatamab) plus pembrolizumab in subjects with UCC as measured by objective response rate (ORR) by RECIST 1.1. ORR is defined as the percentage of subjects who have baseline measurable disease and who achieve a best response of either complete response (CR) or partial response (PR).
Measured: 2 years
Secondary outcomes (6)
Assessment of Changes in Biomarkers Induced by B-701 (Vofatamab)
Whole blood (PBMCs), serum, and plasma samples for biomarker analyses will be obtained prior to infusion of B-701 at pre-defined visit days.
The effects of B-701 on the downstream signaling of the FGFR3 pathway, tumor sub-type and on the immune surveillance of UCC tumors will be monitored using techniques that include gene expression profiling (such as whole transcriptome RNAseq), sequencing of T-cell receptors, and immunohistochemistry.
Measured: 2.5 years
Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by DOR
Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by duration of objective response (DOR), defined as the time from first occurrence of a documented, objective response until the time of relapse or death from any cause (RECIST 1.1).
Measured: 2 years
Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by DCR
Evaluate the efficacy of B-701 in combination with pembrolizumab in the treatment of subjects with UCC as measured by disease control rate (DCR), defined as the percentage of subjects who achieve either complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST 1.1.
Measured: 2 years
Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by PFS
Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by progression-free survival (PFS), defined as the time from a first study treatment dose to first occurrence of disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Measured: 2 years
Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by OS
Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by overall survival (OS), defined as the time from first study drug administration to death from any cause (RECIST 1.1)
Measured: 2.5 years
Change in Subject Reported Quality of Life
Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by the change over time in subject reported quality of life as measured by the European Organization for Research and Treatment Quality of Life Questionnaire (EORTC QLQ-C30).
Measured: 2 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 2017
- Study start20 Apr 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: program has been put on hold by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Locally Advanced or Metastatic Urothelial 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- B-701 (vofatamab) as monotherapy for first 2 weeks followed by B-701 (vofatamab) in combination with pembrolizumab thereafter.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rainier Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainier Therapeutics, Study chair, Rainier Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123055
- Sponsor's protocol ID
- B-701-U22
- Other IDs
- 2017-001292-23, 2017
- Acronym
- FIERCE-22
- Status last verified
- Feb 2020
- First submitted
- 11 Apr 2017
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT03123055
- Acronym / sponsor ID
- FIERCE-22 / B-701-U22
- Conditions
- Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases
- Keywords
- Urothelial Cell Carcinoma, UCC, bladder cancer, B-701, FGFR3, invasive bladder cancer, Transitional Cell Carcinoma, TCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: program has been put on hold by the sponsor
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Rainier TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 18 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.
Detailed description
This is a Phase 1b/2 multi-center, open-label study to determine the safety, tolerability, and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor or FGFR inhibitor-targeted therapy. The study consists of 2 parts: a Phase 1b lead-in phase enrolling 6 to 18 subjects and a Phase 2 dose expansion phase enrolling up to a total of 74 subjects.
Subjects who discontinue B-701 (vofatamab) may continue on study and receive pembrolizumab alone until disease progression, death, withdrawal of patient consent, or study termination. Subjects who discontinue pembrolizumab may continue on study and receive B-701 (vofatamab) alone until disease progression, death, withdrawal of patient consent, or study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- B-701 (vofatamab) as monotherapy for first 2 weeks followed by B-701 (vofatamab) in combination with pembrolizumab thereafter.
| Arm | Type | Receives |
|---|---|---|
| B-701 (vofatamab) | Experimental | Drug: B-701B-701 (vofatamab, 25 mg/kg) will be administered via IV infusion on Cycle 0 Day 1 for a single 14-day cycle. |
| B-701 (vofatamab) plus pembrolizumab | Experimental | Drug: B-701, Drug: PembrolizumabB-701 (vofatamab, 25 mg/kg [or the recommended Phase 2 dose if different than 25 mg/kg]) plus pembrolizumab (200 mg) will be administered by IV infusion on Cycle 1 Day 1 once every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic transitional cell carcinoma of the urothelium, including of the urinary bladder, urethra, ureter, and/or renal pelvis. The diagnosis must be histologically or cytologically confirmed.
- Have progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- Have available archival tumor or be willing to undergo diagnostic biopsy at screening. Sample must be of suitable quality and quantity to satisfy group assignment and biomarker endpoints.
- Have measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
Key exclusion criteria (5 listed)
- Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest CT scan.
- Prior therapy with an anti-programmed cell death 1 (PD-1) or anti-PD-Ligand 1 agent, or with an agent directed to another co-inhibitory T-cell receptor or FGFR inhibitor.
- Patients with autoimmune disease or medical conditions that required systemic corticosteroids (> 10 mg/day prednisone or its equivalent) or other immunosuppressive medications or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment. Note: Replacement therapy (e.g. physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Primary central nervous system (CNS) malignancy or CNS metastases.
- History of clinically significant coagulation or platelet disorder in the past 12 months.
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 |
|---|---|---|
| B-701Also: MFGR1877S, VofatamabB-701 (vofatamab) is a human IgG1 monoclonal antibody that is highly specific for the FGFR3 receptor. | Drug | B-701 (vofatamab), B-701 (vofatamab) plus pembrolizumab |
| PembrolizumabAlso: KeytrudaPembrolizumab is a humanized antibody used in cancer immunotherapy. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells. | Drug | B-701 (vofatamab) plus pembrolizumab |
Primary outcome
Number of Participants With Dose Limiting Toxicities Within a Period of 35 Days
Time frame: 1 year
Number of Participants with Dose Limiting Toxicities within a period of 35 days will be analyzed reviewing the aggregate of adverse events (AEs) and serious adverse events (SAEs) by the B-701 program Safety Oversight Committee and will result in a recommended Phase 2 dose. Six subjects at a time are enrolled and observed for 35 days after the initial dose. If 2 or more subjects experience a DLT that dose will be declared intolerable and de-escalation of the dose will occur.
Number of Subjects Experiencing Adverse Events (AEs and SAEs)
Time frame: 2.5 years
Evaluate the safety and tolerability of B-701 (vofatamab) plus pembrolizumab in subjects with UCC as assessed by number of subjects experiencing adverse events (AEs and SAEs), physical examination findings, laboratory test results, and vital signs over time. This outcome is measured by a safety monitoring committee who regularly met and reviewed aggregate trends of reports AEs, lab ranges, physical exams etc. and determined if the drug was safe to continue.
Efficacy of B-701 (Vofatamab) Plus Pembrolizumab Measured by ORR
Time frame: 2 years
Evaluate the efficacy of B-701 (vofatamab) plus pembrolizumab in subjects with UCC as measured by objective response rate (ORR) by RECIST 1.1. ORR is defined as the percentage of subjects who have baseline measurable disease and who achieve a best response of either complete response (CR) or partial response (PR).
6 secondary outcomes
Assessment of Changes in Biomarkers Induced by B-701 (Vofatamab)
Time frame: 2.5 years
Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by DOR
Time frame: 2 years
Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by DCR
Time frame: 2 years
Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by PFS
Time frame: 2 years
Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by OS
Time frame: 2.5 years
Change in Subject Reported Quality of Life
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced or Metastatic Urothelial Cell Carcinoma
RecruitingPhase 1/2
A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
Locally Advanced or Metastatic Malignant Solid Tumors
RecruitingPhase 1
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
Ovarian Cancer, Pancreas Cancer
RecruitingPhase 1/2
AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
Solid Tumor Cancer, Locally Advanced
RecruitingPhase 1/2
Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
Urothelial Cancer, Advanced/Metastatic Urothelial Cancer
RecruitingPhase 3
A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
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.
Rainier Therapeutics study chair
Rainier Therapeutics
52 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing B-701 and Pembrolizumab in people with Locally Advanced or Metastatic Urothelial Cell Carcinoma and Urinary Bladder Disease, run by Rainier Therapeutics at 52 sites in 17 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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Germany, Poland, Serbia, Spain and 12 more countries. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 18 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Dose Limiting Toxicities Within a Period of 35 Days (time frame: 1 year). The study lists 3 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 18 Mar 2020.