Cutaneous MelanomaPhase 3NCT02288897
PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
A Phase 3 study testing PV-10 (10% rose bengal disodium) and Dacarbazine, temozolomide or talimogene laherparepvec in people with Cutaneous Melanoma, run by Provectus Biopharmaceuticals, Inc. at 23 sites in 5 countries.
Trial summary
This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- PV-10 (10% rose bengal disodium) and Dacarbazine, temozolomide or talimogene laherparepvec
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 23 sitesin 5 countries
- Study dates
- Apr 2015to Sep 2019
- Phase
- Phase 3
- 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
- Age 18 years or older, male or female
- Histologically or cytologically confirmed melanoma
- Recurrent, satellite or in-transit locally advanced cutaneous or subcutaneous melanoma metastases (i.e., American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC or Stage IV M1a with no active nodal metastases)
- At least 1 measurable Target Lesion that can be accurately measured by calipers or computed tomography (CT) consisting of:
- at least one cutaneous lesion (each lesion ≥ 10 mm in longest diameter or up to 5 lesions having a sum of longest diameters ≥ 10 mm); and/or
- at least one subcutaneous lesion (each lesion ≥ 10 mm in longest diameter by CT);
Show all 22Show fewer
- where Target Lesions should be at least 10 mm from any other lesion
- No lesion > 50 mm in longest diameter; and no more than 50 lesions
- Calculated required PV-10 dose ≤ 15 mL (based on total tumor burden)
- Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2
- Not a candidate for treatment with an immune checkpoint inhibitor (e.g., failed or did not tolerate prior therapy, or due to co-morbidities, pre-existing autoimmune disease, drug unavailability or standard of care)
- Not a candidate for targeted therapy with BRAF or combined BRAF/MEK inhibitors (e.g., failed or did not tolerate prior therapy, BRAF V600 wild-type or due to drug unavailability or standard of care)
- Clinical Laboratories:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelet count ≥100 x 10^9/L
- Creatinine ≤ 3 times the upper limit of normal (ULN)
- Estimated creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
- Total bilirubin ≤ 3 times the upper limit of normal (ULN)
- Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal (ULN)
- Lactate dehydrogenase (LDH) ≤ 2 times the upper limit of normal (ULN).
- Thyroid function abnormality ≤ Grade 2
- Candidate for at least one comparator drug:
- Subjects must be candidates for at least one of the designated comparator drugs
Who cannot join
- Presence or history of visceral melanoma metastasis
- Presence of active nodal metastases (e.g., radiologic or clinical evidence of current nodal disease)
- Presence of more than 50 melanoma lesions
- Radiation therapy to any Study Lesion within 6 weeks of initial study treatment.
- Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
- Immunotherapy for cancer within 4 weeks of initial study treatment
Show all 21Show fewer
- Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4 weeks of initial study treatment
- Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
- Investigational agents within 4 weeks of initial study treatment.
- Concurrent or Intercurrent Illness:
- Impaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremity
- Severe peripheral vascular disease in subjects whose Study Lesions are located in an extremity
- Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise the subject's safety or compliance or interfere with interpretation of study results.
- Uncontrolled thyroid disease or cystic fibrosis
- Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders
- Pregnancy:
- Female subjects who are pregnant or lactating
- Female subjects who have positive serum pregnancy test taken within 14 days of study treatment
- Female subjects of child-bearing potential who are unwilling to use highly effective contraception (e.g., combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives, intrauterine devices, bilateral tubal ligation, vasectomized partner, sexual abstinence or equivalent measures) for the duration of study treatment
- Contraindication for all comparators:
- Subjects with contraindications to all of the designated comparator drugs
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
United States12 sites
St Luke's University Hospital and Health Network
Easton, Pennsylvania, 18045
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
M.D. Anderson Cancer Center
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Atlantic Health System
Morristown, New Jersey, 07960
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Sharp Memorial Hospital - Clinical Oncology Research
San Diego, California, 92123
Washington University School of Medicine - Dermatology
St Louis, Missouri, 63110
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Germany4 sites
Klinik für Dermatologie, Venerologie und Allergologie Charite Universitätsmedizin Berlin
Berlin
Klinik für Dermatologie Universitätsklinikum Essen Studienzentrum
Essen
Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein Hautkrebszentrum
Kiel
Hautklinik Klinikum der Johannes Gutenberg Universität Hautkrebszentrum
Mainz
Italy3 sites
IRCCS Instituto Nazionale Tumori "Fondazione Giovanni Pascale"
Naples
Istituto Dermopatico dell'Immacolata (IDI IRCCS)
Rome
Azienda Sanitaria Azienda Ospedaliera Universitaria Senese
Siena
France2 sites
Unité Cancéro-Dermatologie, Hôtel-Dieu CHU Nantes
Nantes
Institut Claudius Regaud, IUCT ONCOPOLE
Toulouse, 31059
Mexico2 sites
Neurociencias Estudios Clínicos S.C.
Culiacán, Sinaloa, 80020
Centro de Estudios y Prevención del Cancer A.C.
Juchitán de Zaragoza, Oaxaca, 70000
About this study
Official title: PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
Read the detailed description
Subjects will be randomized using a 2:1 treatment allocation (i.e. two-thirds of the subjects will receive PV-10).
Subjects in the comparator arm who have completed at least 1 cycle of study treatment and who meet the study protocol definition of disease progression but do not have evidence of visceral metastases will be eligible to enter the crossover portion of the study and receive PV-10. Subjects crossing over must meet all study inclusion and exclusion criteria for clinical laboratories, thyroid function, concurrent or intercurrent illness and pregnancy at the time of crossover.
Assessment of progression will be performed by an Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1 criteria. Events signaling progression include increase in size and/or number of lesions, distant or nodal disease progression, or death. All secondary endpoints involving disease response and progression will be based on the IRC determination.
An interim assessment of efficacy and safety will be performed by the IRC when 50% of the events required for the primary endpoint have occurred.
- Conditions
- Cutaneous Melanoma
- Being tested
- PV-10 (10% rose bengal disodium), Dacarbazine, temozolomide or talimogene laherparepvec
- Keywords
- Stage III, Stage IIIB, Stage IIIC, Stage IV (M1a), Stage 3, Stage 4, IVM1a, IV(M1a), IV-M1a, in-transit, in transit, intransit, satellite, recurrent
- Medical subject headings
- Melanoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PV-10 (10% rose bengal disodium)Drug
Dacarbazine, temozolomide or talimogene laherparepvecDrug
| Study group | Role | What they receive |
|---|---|---|
| PV-10 | Experimental | Subjects will receive intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination occurs. Receives: Drug: PV-10 (10% rose bengal disodium) |
| Chemotherapy or Oncolytic Viral Therapy | Active comparator | Subjects will receive (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination occurs. Receives: Drug: Dacarbazine, temozolomide or talimogene laherparepvec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS was estimated via Kaplan-Meier analysis using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Subjects who did not have an event of progression or death were censored at their last assessment date.
Assessment of progression was performed by the sponsor based on review of lesion measurement and clinical progression data reported by each investigator. Events signaling progression included increase in size and/or number of study lesions, onset of visceral metastatic disease, and death. For target lesions (assigned prior to randomization), complete response (CR) required disappearance of all target lesions; partial response (PR) required >= 30% decrease in sum of the longest diameter (SLD) of all target lesions; progressive disease (PD) required >=20% increase in SLD of target lesions. Non-target lesions were followed for CR, PD, or non-CR/non-PD status using equivalent thresholds. Progression occurred when PD was observed in either target or non-target lesion.
Measured: Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; progression detected between formal assessments was documented at the time of detection; median follow-up time for PFS was 26.6 weeks, maximum was 125.8 weeks.
Secondary outcomes (4)
Complete Response Rate (CRR)
CRR was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions.
Measured: Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; median follow-up time for CRR was 26.6 weeks, maximum was 125.8 weeks.
Duration of Complete Response (DCR)
DCR was estimated via Kaplan-Meier analysis for participants achieving a complete response, and was defined as the interval from first complete response to disease progression or death; responders who did not have an event of progression or death were censored at their last assessment date. Complete response was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions.
Measured: Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; median follow-up time for DCR was 26.7 weeks, maximum was 77.7 weeks.
Overall Survival (OS)
OS was documented at 12 week intervals commencing on withdrawal from active study participation. Documentation was made by subject clinic visit or other personal contact, telephonic contact, review of medical records, or other unequivocal evidence of survival status. OS was estimated via Kaplan-Meier analysis, and was defined as the interval from randomization to death; subjects who did not have an event of death were censored at their last assessment date.
Measured: Assessed every 12 weeks upon withdrawal from active study participation until death, withdrawal of consent, or study termination; median follow-up time for survival was 82.4 weeks, maximum was 167.0 weeks.
Number of Participants With Adverse Events
Safety and tolerability were assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs.
Measured: Assessed every 4 weeks until 28 days after last treatment; median duration of treatment was 11.8 and 9.5 weeks in each treatment group, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionApr 2019
- Study completionSep 2019
Why it stopped: Inadequate rate of enrollment
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 Cutaneous 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provectus Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Wachter, Ph.D., Study director, Provectus Biopharmaceuticals, Inc.Sanjiv Agarwala, M.D., Principal investigator, St Luke's University Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288897
- Sponsor's protocol ID
- PV-10-MM-31
- Status last verified
- Jan 2022
- First submitted
- 4 Nov 2014
- Last updated
- 19 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT02288897
- Acronym / sponsor ID
- PV-10-MM-31
- Conditions
- Cutaneous Melanoma
- Keywords
- Stage III, Stage IIIB, Stage IIIC, Stage IV (M1a), Stage 3, Stage 4, IVM1a, IV(M1a)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate rate of enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Provectus Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Posted 19 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
Detailed description
Subjects will be randomized using a 2:1 treatment allocation (i.e. two-thirds of the subjects will receive PV-10).
Subjects in the comparator arm who have completed at least 1 cycle of study treatment and who meet the study protocol definition of disease progression but do not have evidence of visceral metastases will be eligible to enter the crossover portion of the study and receive PV-10. Subjects crossing over must meet all study inclusion and exclusion criteria for clinical laboratories, thyroid function, concurrent or intercurrent illness and pregnancy at the time of crossover.
Assessment of progression will be performed by an Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1 criteria. Events signaling progression include increase in size and/or number of lesions, distant or nodal disease progression, or death. All secondary endpoints involving disease response and progression will be based on the IRC determination.
An interim assessment of efficacy and safety will be performed by the IRC when 50% of the events required for the primary endpoint have occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PV-10 | Experimental | Drug: PV-10 (10% rose bengal disodium)Subjects will receive intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination occurs. |
| Chemotherapy or Oncolytic Viral Therapy | Active comparator | Drug: Dacarbazine, temozolomide or talimogene laherparepvecSubjects will receive (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination occurs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age 18 years or older, male or female
- Histologically or cytologically confirmed melanoma
- Recurrent, satellite or in-transit locally advanced cutaneous or subcutaneous melanoma metastases (i.e., American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC or Stage IV M1a with no active nodal metastases)
- At least 1 measurable Target Lesion that can be accurately measured by calipers or computed tomography (CT) consisting of:
- No lesion > 50 mm in longest diameter; and no more than 50 lesions
Key exclusion criteria (21 listed)
- Presence or history of visceral melanoma metastasis
- Presence of active nodal metastases (e.g., radiologic or clinical evidence of current nodal disease)
- Presence of more than 50 melanoma lesions
- Radiation therapy to any Study Lesion within 6 weeks of initial study treatment.
- Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
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 |
|---|---|---|
| PV-10 (10% rose bengal disodium) | Drug | PV-10 |
| Dacarbazine, temozolomide or talimogene laherparepvec | Drug | Chemotherapy or Oncolytic Viral Therapy |
Primary outcome
Progression-free Survival (PFS)
Time frame: Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; progression detected between formal assessments was documented at the time of detection; median follow-up time for PFS was 26.6 weeks, maximum was 125.8 weeks.
PFS was estimated via Kaplan-Meier analysis using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Subjects who did not have an event of progression or death were censored at their last assessment date. Assessment of progression was performed by the sponsor based on review of lesion measurement and clinical progression data reported by each investigator. Events signaling progression included increase in size and/or number of study lesions, onset of visceral metastatic disease, and death. For target lesions (assigned prior to randomization), complete response (CR) required disappearance of all target lesions; partial response (PR) required >= 30% decrease in sum of the longest diameter (SLD) of all target lesions; progressive disease (PD) required >=20% increase in SLD of target lesions. Non-target lesions were followed for CR, PD, or non-CR/non-PD status using equivalent thresholds. Progression occurred when PD was observed in either target or non-target lesion.
4 secondary outcomes
Complete Response Rate (CRR)
Time frame: Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; median follow-up time for CRR was 26.6 weeks, maximum was 125.8 weeks.
Duration of Complete Response (DCR)
Time frame: Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; median follow-up time for DCR was 26.7 weeks, maximum was 77.7 weeks.
Overall Survival (OS)
Time frame: Assessed every 12 weeks upon withdrawal from active study participation until death, withdrawal of consent, or study termination; median follow-up time for survival was 82.4 weeks, maximum was 167.0 weeks.
Number of Participants With Adverse Events
Time frame: Assessed every 4 weeks until 28 days after last treatment; median duration of treatment was 11.8 and 9.5 weeks in each treatment group, respectively.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Eric Wachter, Ph.D. study director
Provectus Biopharmaceuticals, Inc.
Sanjiv Agarwala, M.D. principal investigator
St Luke's University Hospital and Health Network
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PV-10 (10% rose bengal disodium) and Dacarbazine, temozolomide or talimogene laherparepvec in people with Cutaneous Melanoma, run by Provectus Biopharmaceuticals, Inc. at 23 sites in 5 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 22 inclusion and 21 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Germany, Italy, France, Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Jan 2022). 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?
Progression-free Survival (PFS) (time frame: Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; progression detected between formal assessments was documented at the time of detection; median follow-up time for PFS was 26.6 weeks, maximum was 125.8 weeks.). 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 19 Jan 2022.