Unresectable Pleural or Peritoneal Malignant MesotheliomaPhase 2TremelimumabNCT01843374
Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma
A Phase 2 study testing Tremelimumab in people with Unresectable Pleural or Peritoneal Malignant Mesothelioma, run by MedImmune LLC at 104 sites in 19 countries.
Trial summary
This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Unresectable Pleural or Peritoneal Malignant Mesothelioma
- What is being tested?
- Tremelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 571 participants
- Where
- 104 sitesin 19 countries
- Study dates
- 17 May 2013to 31 May 2027
- Phase
- Phase 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma;
- Disease not amenable to curative surgery;
- Age 18 and over at the time of consent;
- ECOG Performance status 0-1;
- Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.
- Recovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or 1, except for toxicities not considered a safety risk,
Show all 12Show fewer
- Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma;
- Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as:
- Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C.
- Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations;
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician.
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product.
Who cannot join
- Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma;
- Received any prior mAb against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1);
- History of chronic inflammatory or autoimmune disease with symptomatic disease within the last 3 years prior to randomization.
- Active, untreated central nervous system (CNS) metastasis
- Any serious uncontrolled medical disorder or active infection that would impair the subject's ability to receive investigational product;
- History of other malignancy unless the subject has been disease-free for at least 3 years;
Show all 19Show fewer
- Pregnant or breast feeding at time of consent;
- Any condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocol;
- Active or history of diverticulitis;
- Active or history of inflammatory bowel disease, irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea. Active or history of systemic lupus erythematosus or granulomatosis with polyangiitis;
- History of sarcoidosis syndrome;
- Currently receiving systemic corticosteroids or other immunosuppressive medications or has a medical condition that requires the chronic use of corticosteroids.
- Subjects should not be vaccinated with live attenuated vaccines within one month prior to starting tremelimumab treatment;
- The last dose of prior chemotherapy or radiation therapy was received less than 2 weeks prior to randomization;
- Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of vitiligo and alopecia;
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results;
- Concurrent enrollment in another clinical study or receipt of an investigational product within the last 4 weeks
- Employees of the study site directly involved with the conduct of the study, or immediate family members of any such individuals;
- Subjects with a history of hypersensitivity to compounds of similar biologic composition to tremelimumab or any constituent of the product.
Trial locations and contacts
104 sites in 19 countries.
104 sites in 19 countries
United States21 sites
Research Site
Augusta, Georgia, 30912
Research Site
Baltimore, Maryland, 21201
Research Site
Baltimore, Maryland, 21231
Research Site
Canton, Ohio, 44710
Research Site
Chicago, Illinois, 60637
Research Site
Dallas, Texas, 75390
Research Site
Durham, North Carolina, 27710
Research Site
Houston, Texas, 77030
Research Site
La Jolla, California, 92093
Research Site
Los Angeles, California, 90025
Research Site
Minneapolis, Minnesota, 55445
Research Site
New Haven, Connecticut, 06511
Research Site
New York, New York, 10065
Research Site
Newark, Delaware, 19718
Research Site
Peoria, Illinois, 61615
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Rochester, New York, 14642
Research Site
San Francisco, California, 94143
Research Site
Santa Monica, California, 90404
Research Site
Scottsdale, Arizona, 85259
Research Site
Tampa, Florida, 33612
Italy12 sites
Research Site
Alessandria, 15100
Research Site
Aviano, 33081
Research Site
Bergamo, 24125
Research Site
Bologna, 40138
Research Site
Candiolo, 10060
Research Site
Genova, 16132
Research Site
Meldola, 47014
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Milan, 20133
Research Site
Orbassano, 10043
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Padova, 35128
Research Site
Rozzano, 20089
Research Site
Siena, 53100
Australia10 sites
Research Site
Adelaide, 5000
Research Site
Auchenflower, 4066
Research Site
Box Hill, 3128
Research Site
Chermside, 4032
Research Site
East Bentleigh, 3165
Research Site
Gosford, 2250
Research Site
Heidelberg, 3084
Research Site
Nedlands, 6009
Research Site
Saint Leonards, 2065
Research Site
Waratah, 2298
Germany10 sites
Research Site
Berlin, 13125
Research Site
Esslingen a.N., 73730
Research Site
Freiburg im Breisgau, 79106
Research Site
Gauting, 82131
Research Site
Großhansdorf, 22927
Research Site
Hamburg, 21075
Research Site
Hemer, 58675
Research Site
Karlsruhe, 76137
Research Site
Löwenstein, 74245
Research Site
Lübeck, 23538
United Kingdom9 sites
Research Site
Leeds, LS9 7TF
Research Site
Leicester, LE1 5WW
Research Site
London, EC1A 7BE
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London, SE1 9RT
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Maidstone, ME16 9QQ
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Manchester, M23 9LT
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Metropolitan Borough of Wirral, CH63 4JY
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Plymouth, PL6 8DH
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Southampton, SO16 6YD
France7 sites
Research Site
Caen, 14076
Research Site
Le Mans, 72037
Research Site
Lille, 59037
Research Site
Nice, 06189
Research Site
Rennes, 35033
Research Site
Toulouse, 31059
Research Site
Villejuif, 94805
Spain5 sites
Research Site
Barcelona, 08035
Research Site
Donostia / San Sebastian, 20014
Research Site
Madrid, 28040
Research Site
Sabadell (Barcelona), 08208
Research Site
Seville, 41013
Poland4 sites
Research Site
Gdansk, 80-952
Research Site
Poznan, 60-693
Research Site
Szczecin, 70-891
Research Site
Warsaw, 02-781
South Korea4 sites
Research Site
Jeonnam, 58128
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Belgium3 sites
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Netherlands3 sites
Research Site
Breda, 4818 CK
Research Site
Eindhoven, 5623EJ
Research Site
Rotterdam, 3015 GD
Russia3 sites
Research Site
Moscow, 115478
Research Site
Nizhny Novgorod, 603006
Research Site
Saint Petersburg, 197022
South Africa3 sites
Research Site
Kraaifontein, 7570
Research Site
Pretoria, 0081
Research Site
Pretoria, 0181
Sweden3 sites
Research Site
Linköping, 58185
Research Site
Lund, 22185
Research Site
Umeå, SE90185
Canada2 sites
Research Site
Sainte-Foy, Quebec, G1V 4G5
Research Site
Toronto, Ontario, M5G 2M9
Hungary2 sites
Research Site
Gyöngyös - Mátraháza, 3200
Research Site
Törökbálint, 2045
About this study
Official title: A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma
This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.
Read the detailed description
This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.
Randomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.
The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.
- Being tested
- Tremelimumab, Placebo
- Keywords
- tremelimumab, pleural, peritoneal, malignant mesothelioma, CTLA-4
- Medical subject headings
- Mesothelioma, Malignant, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
Tremelimumab is to be administered as an IV solution, followed by observation.
PlaceboDrug
Placebo is to be administered as an IV solution, followed by observation.
| Study group | Role | What they receive |
|---|---|---|
| Tremelimumab | Experimental | Tremelimumab Receives: Drug: Tremelimumab |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival (OS) by treatment arm
Measured: 3 years.
Secondary outcomes (9)
OS Rate at 18 Months by Treatment Arm
The percentage of patients still alive at 18 months
Measured: 18 months
Progression-free Survival by Treatment Arm
Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Overall Response Rate by Treatment Arm
Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
Measured: Time from randomization to best response to treatment, assessed up to 3 years.
Duration of Response by Treatment Arm
Duration of response will be defined as the duration from the first documentation of complete response (CR), partial response (PR) to the first documented disease progression.
Measured: Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.
Disease Control Rate by Treatment Arm
Disease control rate (DCR) is defined as the proportion of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 12 weeks duration
Measured: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Durable Disease Control Rate by Treatment Arm
Durable disease control rate (DDCR) is defined as the percentage of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 6 months duration
Measured: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Number of Participants Reporting Any Adverse Event
Any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Day 1- 90 days post dose
Number of Participants Reporting Any Serious Adverse Events
Measured: Day 1 to 90 days post dose
Number of Participants With Positive Anti-drug Antibodies
The immunogenicity titer is reported for samples confirmed positive for the presence of anti tremelimumab antibodies.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study start17 May 2013
- Primary completion24 Jan 2016
- Study completion31 May 2027 (estimated)
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable Pleural or Peritoneal Malignant MesotheliomaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843374
- Sponsor's protocol ID
- D4880C00003
- Other IDs
- 2012-003524-21
- Acronym
- Tremelimumab
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2013
- Last updated
- 27 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
Baverel P, Roskos L, Tatipalli M, Lee N, Stockman P, Taboada M, Vicini P, Horgan K, Narwal R. Exposure-Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status. Clin Transl Sci. 2019 Sep;12(5):450-458. doi: 10.1111/cts.12633. Epub 2019 Apr 12.
PubMed 30883000Maio M, Scherpereel A, Calabro L, Aerts J, Perez SC, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. doi: 10.1016/S1470-2045(17)30446-1. Epub 2017 Jul 17.
PubMed 28729154
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT01843374
- Acronym / sponsor ID
- Tremelimumab / D4880C00003
- Keywords
- tremelimumab, pleural, peritoneal, malignant mesothelioma, CTLA-4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 571 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 17 May 2013 (actual)
- Primary completion
- 24 Jan 2016 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Posted 17 Aug 2017
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 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.
Detailed description
This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.
Randomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.
The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tremelimumab | Experimental | Drug: TremelimumabTremelimumab |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma;
- Disease not amenable to curative surgery;
- Age 18 and over at the time of consent;
- ECOG Performance status 0-1;
- Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.
Key exclusion criteria (19 listed)
- Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma;
- Received any prior mAb against CTLA-4, programmed cell death 1 (PD1) or programmed cell death 1 ligand 1 (PD-L1);
- History of chronic inflammatory or autoimmune disease with symptomatic disease within the last 3 years prior to randomization.
- Active, untreated central nervous system (CNS) metastasis
- Any serious uncontrolled medical disorder or active infection that would impair the subject's ability to receive investigational product;
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 |
|---|---|---|
| TremelimumabTremelimumab is to be administered as an IV solution, followed by observation. | Drug | Tremelimumab |
| PlaceboPlacebo is to be administered as an IV solution, followed by observation. | Drug | Placebo |
Primary outcome
Overall Survival (OS)
Time frame: 3 years.
Overall survival (OS) by treatment arm
9 secondary outcomes
OS Rate at 18 Months by Treatment Arm
Time frame: 18 months
Progression-free Survival by Treatment Arm
Time frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Overall Response Rate by Treatment Arm
Time frame: Time from randomization to best response to treatment, assessed up to 3 years.
Duration of Response by Treatment Arm
Time frame: Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.
Disease Control Rate by Treatment Arm
Time frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Durable Disease Control Rate by Treatment Arm
Time frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Number of Participants Reporting Any Adverse Event
Time frame: Day 1- 90 days post dose
Number of Participants Reporting Any Serious Adverse Events
Time frame: Day 1 to 90 days post dose
Number of Participants With Positive Anti-drug Antibodies
Time frame: Week 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30883000Baverel P, Roskos L, Tatipalli M, Lee N, Stockman P, Taboada M, Vicini P, Horgan K, Narwal R. Exposure-Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status. Clin Transl Sci. 2019 Sep;12(5):450-458. doi: 10.1111/cts.12633. Epub 2019 Apr 12.
- Derived from this study: PubMed 28729154Maio M, Scherpereel A, Calabro L, Aerts J, Perez SC, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. doi: 10.1016/S1470-2045(17)30446-1. Epub 2017 Jul 17.
- FINAL Redacted PROTOCOL\_ 03Jan2017Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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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.
The record lists no contact. Use the official record to reach the sponsor.
104 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tremelimumab in people with Unresectable Pleural or Peritoneal Malignant Mesothelioma, run by MedImmune LLC at 104 sites in 19 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 12 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Italy, Australia, Germany, United Kingdom and 14 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2017). 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?
Overall Survival (OS) (time frame: 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843374, which also lists 2 linked publications.
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 27 Jul 2026.