LeukemiaPhase 2NCT02599649
Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)
A Phase 2 study testing Lirilumab, Nivolumab and Azacitidine in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab), alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of these drug combinations will also be studied. This is an investigational study. Lirilumab is not FDA approved or commercially available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Lirilumab, Nivolumab and Azacitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2016to 30 Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with MDS (up to 20% blasts) of any risk. Patients with lower risk MDS (low and int-1 by IPSS) could have received prior non-hypomethylating agent therapy (ie growth factors or lenalidomide). Patients with higher risk MDS (int-2 or high by IPSS) should not have received prior therapy with a hypomethylating agent.
- Age 18 years or older.
- Adequate organ function: creatinine </=2.5 x Upper Limit of Normal (ULN); serum bilirubin </=2.5 x ULN; aspartate transaminase (AST) and alanine transaminase (ALT) </=2.5 x ULN.
- Eastern Cooperative Oncology Group (ECOG) performance status </=2.
- Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
- Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks after the last dose of nivolumab.
- Patients or their legally authorized representative must provide written informed consent.
Who cannot join
- History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
- Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs.
- Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association (NYHA) Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study.
- Patients unwilling or unable to comply with the protocol.
- Patients who are on high dose steroid (ie prednisone or equivalent more than 10 mg a day) or immune suppression medications.
- Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]).
Show all 13Show fewer
- Patients with a history of Inflammatory Bowel Disease such as Crohn's disease and ulcerative colitis
- Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months) or with a history of HIV disease.
- Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents.
- Females who are pregnant or lactating
- Prior treatment with stem cell transplantation.
- Prohibited Prior Treatments and/or Therapies: a) Prior therapy with an anti-KIR, anti-PD-1, or anti-PD-L1, antibody. b) Prior treatment regimens with any immune cell modulating antibody such as anti-CD137 and anti-OX40. However, prior anti-CTLA4 therapy is allowed if the last dose is 101 days or more from the first dose of study drug. c) Exposure to any other investigational drug within 2 weeks prior to the first dose of study drug (within 101 days for anti-CTLA4 therapy). d) Any anti-cancer therapy (e.g., chemotherapy, biologics, vaccines, radiotherapy with curative intent, or hormonal treatment) within 2 weeks prior to the first dose of study drug administration (within 101 days for anti-CTLA4 therapy administration.
- Continued from #12: e) Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to study drug. The use of the inactivated seasonal influenza vaccine (Fluzone®) is allowed. f) Systemic corticosteroid at immunosuppressive doses (> 10 mg/day of prednisone or equivalent), must be discontinued at least 2 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Combination of Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)
The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab), alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of these drug combinations will also be studied.
This is an investigational study. Lirilumab is not FDA approved or commercially available. It is currently being used for research purposes. Nivolumab is FDA approved and commercially available for the treatment of melanoma and non small cell lung cancer (NSCLC). Azacitidine is FDA approved and commercially available for the treatment of MDS. The study doctor can explain how the study drugs are designed to work.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
Read the detailed description
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups based on the status of the disease and then you will be assigned to a cohort based on when you join this study. Each study group will be made up of 2 cohorts. Group 1 is made up of Cohorts A and B. Group 2 is made up of Cohorts C and D. Each cohort will enroll up to 20 participants each.
Each study cycle is 4 weeks.
If you have low risk (low or intermediate-1) MDS, you will be enrolled in Group 1.
- If you are assigned to Cohort A, you will receive lirilumab by vein over about 1 hour 1 time each cycle.
- If you are assigned to Cohort B, you will receive nivolumab by vein over about 1 hour every 2 weeks during Cycles 1-9 and then 1 time each cycle after that. You will also receive lirilumab by vein over about 1 hour 1 time each cycle.
If you have high risk MDS, you will be enrolled in Group 2.
- If you are assigned to Cohort C, you will receive azacitidine by vein for up to 40 minutes on Days 1-7 of each cycle. You will also receive lirilumab by vein over about 1 hour on Day 7 of each cycle.
- If you are assigned to Cohort D, you will receive azacitidine by vein for up to 40 minutes on Days 1-7 of each cycle. You will receive lirilumab by vein over about 1 hour on Day 7 of each cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, you will also receive nivolumab by vein over about 1 hour.
If you are assigned to Cohorts B or D, you will need to stay in the clinic for up to 1 hour after your dose of nivolumab so the study staff may check your vitals and monitor your health for any side effects.
Both you and the study doctor will know to which group you have been assigned.
Study Visits:
One (1) time each week during Cycle 1 and then 1 time during each cycle after that:
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests. These tests may be done more often if your doctor thinks it is needed.
If the doctor thinks it is needed, on Day 28 of Cycle 1 and then every 3 months after that, you will have a bone marrow aspiration to check the status of the disease and for cytogenetic testing.
Every 6 weeks, if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
Length of Study:
You may continue receiving the study drug(s) as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
You participation on this study, if you cannot become pregnant, will end after your last dose of study drug(s). If you can become pregnant, your participation on this study will be over after the follow-up pregnancy tests.
Follow-Up Pregnancy Tests:
If you can become pregnant, at 30 days and 70 days after you have stopped taking the study drug(s), blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
- Conditions
- Leukemia
- Being tested
- Lirilumab, Nivolumab, Azacitidine
- Keywords
- Myelodysplastic syndrome, MDS, Low or intermediate-1 MDS, High Risk MDS, Lirilumab, Nivolumab, BMS-936558, Opdivo, Azacitidine, 5-azacytidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816, Azacytidine
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LirilumabDrug
3 mg/kg by vein every 4 weeks.
NivolumabDrug
Also called BMS-936558, Opdivo
3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.
AzacitidineDrug
Also called 5-azacytidine, 5-aza, Vidaza, 5-AZC
75 mg/m^2 by vein for 7 days of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Low or Intermediate-1 MDS Group - Lirilumab | Experimental | Lirilumab by vein over about 60 minutes 1 time each 28 day cycle. Receives: Drug: Lirilumab |
| Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | Experimental | Nivolumab by vein over about 60 minutes every 2 weeks during Cycles 1-9. Lirilumab by vein over about 60 minutes 1 time each cycle. Cycle is 28 days. Receives: Drug: Lirilumab; Drug: Nivolumab |
| High Risk MDS Group - Azacitidine + Lirilumab | Experimental | Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. Receives: Drug: Lirilumab; Drug: Azacitidine |
| High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab | Experimental | Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, Nivolumab by vein over about 60 minutes. Receives: Drug: Lirilumab; Drug: Nivolumab; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall response rate (ORR) defined as complete response plus partial response (CR + PR) and hematological improvement (HI). MDS International Working Group criteria used to assess response.
Measured: 116 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start21 Mar 2016
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Why it stopped: Enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies.
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 (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Guillermo Garcia-Manero, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599649
- Sponsor's protocol ID
- 2014-0934
- Other IDs
- NCI-2015-02120
- Status last verified
- Jan 2020
- First submitted
- 5 Nov 2015
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yalniz FF, Daver N, Rezvani K, Kornblau S, Ohanian M, Borthakur G, DiNardo CD, Konopleva M, Burger J, Gasior Y, Pierce S, Kantarjian H, Garcia-Manero G. A Pilot Trial of Lirilumab With or Without Azacitidine for Patients With Myelodysplastic Syndrome. Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):658-663.e2. doi: 10.1016/j.clml.2018.06.011. Epub 2018 Jun 15.
PubMed 30001986
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Combination of Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)
- ClinicalTrials.gov ID
- NCT02599649
- Acronym / sponsor ID
- 2014-0934
- Conditions
- Leukemia
- Keywords
- Myelodysplastic syndrome, MDS, Low or intermediate-1 MDS, High Risk MDS, Lirilumab, Nivolumab, BMS-936558, Opdivo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab), alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of these drug combinations will also be studied.
This is an investigational study. Lirilumab is not FDA approved or commercially available. It is currently being used for research purposes. Nivolumab is FDA approved and commercially available for the treatment of melanoma and non small cell lung cancer (NSCLC). Azacitidine is FDA approved and commercially available for the treatment of MDS. The study doctor can explain how the study drugs are designed to work.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed description
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups based on the status of the disease and then you will be assigned to a cohort based on when you join this study. Each study group will be made up of 2 cohorts. Group 1 is made up of Cohorts A and B. Group 2 is made up of Cohorts C and D. Each cohort will enroll up to 20 participants each.
Each study cycle is 4 weeks.
If you have low risk (low or intermediate-1) MDS, you will be enrolled in Group 1.
- If you are assigned to Cohort A, you will receive lirilumab by vein over about 1 hour 1 time each cycle.
- If you are assigned to Cohort B, you will receive nivolumab by vein over about 1 hour every 2 weeks during Cycles 1-9 and then 1 time each cycle after that. You will also receive lirilumab by vein over about 1 hour 1 time each cycle.
If you have high risk MDS, you will be enrolled in Group 2.
- If you are assigned to Cohort C, you will receive azacitidine by vein for up to 40 minutes on Days 1-7 of each cycle. You will also receive lirilumab by vein over about 1 hour on Day 7 of each cycle.
- If you are assigned to Cohort D, you will receive azacitidine by vein for up to 40 minutes on Days 1-7 of each cycle. You will receive lirilumab by vein over about 1 hour on Day 7 of each cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, you will also receive nivolumab by vein over about 1 hour.
If you are assigned to Cohorts B or D, you will need to stay in the clinic for up to 1 hour after your dose of nivolumab so the study staff may check your vitals and monitor your health for any side effects.
Both you and the study doctor will know to which group you have been assigned.
Study Visits:
One (1) time each week during Cycle 1 and then 1 time during each cycle after that:
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests. These tests may be done more often if your doctor thinks it is needed.
If the doctor thinks it is needed, on Day 28 of Cycle 1 and then every 3 months after that, you will have a bone marrow aspiration to check the status of the disease and for cytogenetic testing.
Every 6 weeks, if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
Length of Study:
You may continue receiving the study drug(s) as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
You participation on this study, if you cannot become pregnant, will end after your last dose of study drug(s). If you can become pregnant, your participation on this study will be over after the follow-up pregnancy tests.
Follow-Up Pregnancy Tests:
If you can become pregnant, at 30 days and 70 days after you have stopped taking the study drug(s), blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low or Intermediate-1 MDS Group - Lirilumab | Experimental | Drug: LirilumabLirilumab by vein over about 60 minutes 1 time each 28 day cycle. |
| Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab | Experimental | Drug: Lirilumab, Drug: NivolumabNivolumab by vein over about 60 minutes every 2 weeks during Cycles 1-9. Lirilumab by vein over about 60 minutes 1 time each cycle. Cycle is 28 days. |
| High Risk MDS Group - Azacitidine + Lirilumab | Experimental | Drug: Lirilumab, Drug: AzacitidineAzacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. |
| High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab | Experimental | Drug: Lirilumab, Drug: Nivolumab, Drug: AzacitidineAzacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, Nivolumab by vein over about 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with MDS (up to 20% blasts) of any risk. Patients with lower risk MDS (low and int-1 by IPSS) could have received prior non-hypomethylating agent therapy (ie growth factors or lenalidomide). Patients with higher risk MDS (int-2 or high by IPSS) should not have received prior therapy with a hypomethylating agent.
- Age 18 years or older.
- Adequate organ function: creatinine </=2.5 x Upper Limit of Normal (ULN); serum bilirubin </=2.5 x ULN; aspartate transaminase (AST) and alanine transaminase (ALT) </=2.5 x ULN.
- Eastern Cooperative Oncology Group (ECOG) performance status </=2.
- Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
Key exclusion criteria (13 listed)
- History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
- Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs.
- Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association (NYHA) Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study.
- Patients unwilling or unable to comply with the protocol.
- Patients who are on high dose steroid (ie prednisone or equivalent more than 10 mg a day) or immune suppression medications.
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 |
|---|---|---|
| Lirilumab3 mg/kg by vein every 4 weeks. | Drug | High Risk MDS Group - Azacitidine + Lirilumab, High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab, Low or Intermediate-1 MDS Group - Lirilumab, Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab |
| NivolumabAlso: BMS-936558, Opdivo3 mg/kg by vein on Days 7 and 21 of a 28 day cycle. | Drug | High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab, Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab |
| AzacitidineAlso: 5-azacytidine, 5-aza, Vidaza, 5-AZC75 mg/m^2 by vein for 7 days of a 28 day cycle. | Drug | High Risk MDS Group - Azacitidine + Lirilumab, High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab |
Primary outcome
Overall Response Rate (ORR)
Time frame: 116 days
Overall response rate (ORR) defined as complete response plus partial response (CR + PR) and hematological improvement (HI). MDS International Working Group criteria used to assess response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30001986Yalniz FF, Daver N, Rezvani K, Kornblau S, Ohanian M, Borthakur G, DiNardo CD, Konopleva M, Burger J, Gasior Y, Pierce S, Kantarjian H, Garcia-Manero G. A Pilot Trial of Lirilumab With or Without Azacitidine for Patients With Myelodysplastic Syndrome. Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):658-663.e2. doi: 10.1016/j.clml.2018.06.011. Epub 2018 Jun 15.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Guillermo Garcia-Manero, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lirilumab, Nivolumab and Azacitidine in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
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 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 6 Jan 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?
Overall Response Rate (ORR) (time frame: 116 days). 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 NCT02599649, which also lists 1 linked publication.
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 14 Jan 2020.