MelanomaPhase 2NCT03300843
Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer
A Phase 2 study testing Peptide loaded dendritic cell vaccine in people with Melanoma and Gastrointestinal Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Exomes are the parts of deoxyribonucleic acid (DNA) that make proteins. Researchers are finding a way to read the letters in the exome. Incorrect letters are called mutations. Tumors contain specific mutations. Researchers can find these mutations in tumors to make treatments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma, Gastrointestinal Cancer, Breast Cancer
- What is being tested?
- Peptide loaded dendritic cell vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 16 Sep 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic melanoma or epithelial cancer with at least one lesion that is resectable or in selected cases, available peripheral blood mononuclear cells (PBMCs)
- Measurable and evaluable metastatic disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Confirmation of the diagnosis of metastatic cancer by the Laboratory of Pathology of National Cancer Institute (NCI).
- All patients must be refractory to approved standard systemic therapy.
- Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
- Greater than or equal to 18 years of age and less than or equal to 70 years of age.
Show all 25Show fewer
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, 2
- Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment.
- Serology:
- Seronegative for Human Immunodeficiency Virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.)
- Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcriptase polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative.
- Hematology
- Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
- White blood cell (WBC) greater than or equal to 3000/mm^3
- Platelet count greater than or equal to 100,000/mm^3
- Hemoglobin > 8.0 g/dl. Subjects may be transfused to reach this cut-off.
- Cluster of differentiation 4 (CD4) count > 200/uL
- Chemistry:
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 5.0 x ULN
- Serum Creatinine less than or equal to 1.6 mg/dl
- Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg/dl.
- More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the vaccine, and patients toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).
- Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Subjects must be co-enrolled On protocol 03-C-0277.
Who cannot join
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
- Active systemic infections (requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses.
- Patients who are receiving any other investigational agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Trial to Evaluate the Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer
Background:
Exomes are the parts of deoxyribonucleic acid (DNA) that make proteins. Researchers are finding a way to read the letters in the exome. Incorrect letters are called mutations. Tumors contain specific mutations. Researchers can find these mutations in tumors to make treatments. Researchers want to use pieces of participants tumors to find the tumor-specific mutations. They also will take participants white blood cells to make a vaccine that they hope will shrink the tumors.
Read more
Objectives:
To see if dendritic vaccine tumor-fighting cells are safe and can cause certain cancer tumors to shrink.
Eligibility:
Adults ages 18-70 who have metastatic melanoma or metastatic epithelial cancer
Design:
The first part of this study was done under protocol 03-C-0277. In that study, white blood cells and pieces of participants' tumors were taken to make a vaccine.
In this study, participants will get a vaccine every 2 weeks for 8 weeks. It will be given both in a vein and under the skin. At each visit, participants will have a physical exam and have blood taken. They will talk about any side effects they have.
After treatment ends, participants will have many follow-up visits for the first year, then once each year after that. Visits will last up to 2 days each. They will include lab tests, imaging studies, and a physical exam. Blood will be taken at each visit. At the first follow-up visit, participants may have leukapheresis, which they also had as part of protocol 03-C-0277. Participants may not have to return to the Clinical Center for these visits.
Read the detailed description
Background:
- Therapeutic vaccination against cancer has proven very challenging with little clinical benefit.
- Vaccines against non-viral tumors have mainly targeted differentiation antigens, cancer testis antigens, and overexpressed antigens. However negative selection in the thymus against these normal nonmutated antigens severely limits the ability to generate high avidity anti-cancer T cells. Such depletion can impair their antitumor activity and limit tumor elimination.
- The National Cancer Institute Surgery Branch (NCI SB) has developed a pipeline for the identification of immunogenic T cell epitopes derived from neoantigens.
- In recent studies, we identified the neoantigens recognized by tumor infiltrating lymphocytes (TIL) that mediated regression in patients with metastatic cancer. Using whole exome sequencing of a resected metastatic nodule followed by high throughput immunologic screening, we were able to demonstrate that tumor regressions were associated with the recognition by the administered TIL of unique somatic mutations that occurred in the cancer.
- We, therefore, aim to use this pipeline to identify immunogenic neoantigens from epithelial cancer patients and to use these defined epitopes for a personalized therapeutic dendritic cell (DC) vaccine.
Objectives:
-Primary objectives:
--To determine the clinical response rate in patients with metastatic melanoma or epithelial cancer who receive this DC vaccine
Eligibility:
- Age greater than or equal to 18 and less than or equal to 70 years
- Eastern Cooperative Oncology Group (ECOG) 0 - 2
- Evaluable metastatic melanoma or epithelial cancer refractory to standard treatment
- Metastatic melanoma or epithelial cancer lesion(s) that is resectable for TIL or in selected cases, available peripheral blood mononuclear cells (PBMC).
Design:
- Patients with metastatic melanoma or epithelial cancer will undergo surgical resection of tumor followed by exome and ribonucleic acid (RNA) sequencing to identify expressed mutations (CONDUCTED UNDER THE National Cancer Institute Surgery Branch (NCI SB) COMPANION PROTOCOL 03-c-0277).
- Patients will undergo apheresis and DC will be cryopreserved for vaccine preparation.
- Immunogenic neoantigens will be identified from TIL and PBMC by high throughput immunologic screening using long peptides and tandem minigenes covering all mutated epitopes.
- Patient will be vaccinated with autologous mature dendritic cells loaded with long peptides and minimal epitopes from defined neoantigens or highly expressed mutations in tumor suppressor or driver genes.
- DC will be administered intravenously and subcutaneously for four cycles at biweekly intervals.
- Blood samples will be taken every two weeks, and patients will be monitored for the quantity and quality of circulating neoantigen-specific T cells.
- Being tested
- Peptide loaded dendritic cell vaccine
- Keywords
- Cell Therapy, Immunotherapy, Vaccines
- Medical subject headings
- Melanoma, Gastrointestinal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide loaded dendritic cell vaccineBiological
On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
| Study group | Role | What they receive |
|---|---|---|
| Peptide loaded dendritic cell vaccine | Experimental | Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Receives: Biological: Peptide loaded dendritic cell vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Had a Clinical Response (Complete Response (CR) + Partial Response (PR)) to Treatment
Response was assessed by the RECIST v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: up to 6 months
Secondary outcomes (2)
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide
Enzyme-linked immunosorbent assay (ELISA) and enzyme-linked immune absorbent spot (ELISpot) assays assessed reactivity to the mutated peptide compared to the non-mutated peptide. Differences of 2-3 fold in these assays over the baseline measurement are indicative of true biologic differences.
Measured: Day 0, Day 14 (± 5 d), Day 28 (± 5 d), and Day 42 (± 5 d)
Number of Participants With Serious and Non-serious Adverse Events
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: Date treatment consent signed to date off study, approximately 6 months and 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start11 Apr 2018
- Primary completion9 Jul 2019
- Study completion16 Sep 2019
Why it stopped: slow accrual
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 (3)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Steven Rosenberg, M.D., National Cancer Institute (NCI)
- Investigators
- Steven A Rosenberg, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300843
- Sponsor's protocol ID
- 170177
- Other IDs
- 17-C-0177
- Status last verified
- Nov 2019
- First submitted
- 3 Oct 2017
- Last updated
- 13 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein L, Hinterberger M, Wirnsberger G, Kyewski B. Antigen presentation in the thymus for positive selection and central tolerance induction. Nat Rev Immunol. 2009 Dec;9(12):833-44. doi: 10.1038/nri2669.
PubMed 19935803Abramson J, Giraud M, Benoist C, Mathis D. Aire's partners in the molecular control of immunological tolerance. Cell. 2010 Jan 8;140(1):123-35. doi: 10.1016/j.cell.2009.12.030.
PubMed 20085707Bos R, Marquardt KL, Cheung J, Sherman LA. Functional differences between low- and high-affinity CD8(+) T cells in the tumor environment. Oncoimmunology. 2012 Nov 1;1(8):1239-1247. doi: 10.4161/onci.21285.
PubMed 23243587
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate the Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer
- ClinicalTrials.gov ID
- NCT03300843
- Acronym / sponsor ID
- 170177
- Keywords
- Cell Therapy, Immunotherapy, Vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Exomes are the parts of deoxyribonucleic acid (DNA) that make proteins. Researchers are finding a way to read the letters in the exome. Incorrect letters are called mutations. Tumors contain specific mutations. Researchers can find these mutations in tumors to make treatments. Researchers want to use pieces of participants tumors to find the tumor-specific mutations. They also will take participants white blood cells to make a vaccine that they hope will shrink the tumors.
Objectives:
To see if dendritic vaccine tumor-fighting cells are safe and can cause certain cancer tumors to shrink.
Eligibility:
Adults ages 18-70 who have metastatic melanoma or metastatic epithelial cancer
Design:
The first part of this study was done under protocol 03-C-0277. In that study, white blood cells and pieces of participants' tumors were taken to make a vaccine.
In this study, participants will get a vaccine every 2 weeks for 8 weeks. It will be given both in a vein and under the skin. At each visit, participants will have a physical exam and have blood taken. They will talk about any side effects they have.
After treatment ends, participants will have many follow-up visits for the first year, then once each year after that. Visits will last up to 2 days each. They will include lab tests, imaging studies, and a physical exam. Blood will be taken at each visit. At the first follow-up visit, participants may have leukapheresis, which they also had as part of protocol 03-C-0277. Participants may not have to return to the Clinical Center for these visits.
Detailed description
Background:
- Therapeutic vaccination against cancer has proven very challenging with little clinical benefit.
- Vaccines against non-viral tumors have mainly targeted differentiation antigens, cancer testis antigens, and overexpressed antigens. However negative selection in the thymus against these normal nonmutated antigens severely limits the ability to generate high avidity anti-cancer T cells. Such depletion can impair their antitumor activity and limit tumor elimination.
- The National Cancer Institute Surgery Branch (NCI SB) has developed a pipeline for the identification of immunogenic T cell epitopes derived from neoantigens.
- In recent studies, we identified the neoantigens recognized by tumor infiltrating lymphocytes (TIL) that mediated regression in patients with metastatic cancer. Using whole exome sequencing of a resected metastatic nodule followed by high throughput immunologic screening, we were able to demonstrate that tumor regressions were associated with the recognition by the administered TIL of unique somatic mutations that occurred in the cancer.
- We, therefore, aim to use this pipeline to identify immunogenic neoantigens from epithelial cancer patients and to use these defined epitopes for a personalized therapeutic dendritic cell (DC) vaccine.
Objectives:
-Primary objectives:
--To determine the clinical response rate in patients with metastatic melanoma or epithelial cancer who receive this DC vaccine
Eligibility:
- Age greater than or equal to 18 and less than or equal to 70 years
- Eastern Cooperative Oncology Group (ECOG) 0 - 2
- Evaluable metastatic melanoma or epithelial cancer refractory to standard treatment
- Metastatic melanoma or epithelial cancer lesion(s) that is resectable for TIL or in selected cases, available peripheral blood mononuclear cells (PBMC).
Design:
- Patients with metastatic melanoma or epithelial cancer will undergo surgical resection of tumor followed by exome and ribonucleic acid (RNA) sequencing to identify expressed mutations (CONDUCTED UNDER THE National Cancer Institute Surgery Branch (NCI SB) COMPANION PROTOCOL 03-c-0277).
- Patients will undergo apheresis and DC will be cryopreserved for vaccine preparation.
- Immunogenic neoantigens will be identified from TIL and PBMC by high throughput immunologic screening using long peptides and tandem minigenes covering all mutated epitopes.
- Patient will be vaccinated with autologous mature dendritic cells loaded with long peptides and minimal epitopes from defined neoantigens or highly expressed mutations in tumor suppressor or driver genes.
- DC will be administered intravenously and subcutaneously for four cycles at biweekly intervals.
- Blood samples will be taken every two weeks, and patients will be monitored for the quantity and quality of circulating neoantigen-specific T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptide loaded dendritic cell vaccine | Experimental | Biological: Peptide loaded dendritic cell vaccinePeptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Metastatic melanoma or epithelial cancer with at least one lesion that is resectable or in selected cases, available peripheral blood mononuclear cells (PBMCs)
- Measurable and evaluable metastatic disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Confirmation of the diagnosis of metastatic cancer by the Laboratory of Pathology of National Cancer Institute (NCI).
- All patients must be refractory to approved standard systemic therapy.
- Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
Key exclusion criteria (5 listed)
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
- Active systemic infections (requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses.
- Patients who are receiving any other investigational agents.
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 |
|---|---|---|
| Peptide loaded dendritic cell vaccineOn days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield. | Biological | Peptide loaded dendritic cell vaccine |
Primary outcome
Percentage of Patients Who Had a Clinical Response (Complete Response (CR) + Partial Response (PR)) to Treatment
Time frame: up to 6 months
Response was assessed by the RECIST v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
2 secondary outcomes
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide
Time frame: Day 0, Day 14 (± 5 d), Day 28 (± 5 d), and Day 42 (± 5 d)
Number of Participants With Serious and Non-serious Adverse Events
Time frame: Date treatment consent signed to date off study, approximately 6 months and 11 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19935803Klein L, Hinterberger M, Wirnsberger G, Kyewski B. Antigen presentation in the thymus for positive selection and central tolerance induction. Nat Rev Immunol. 2009 Dec;9(12):833-44. doi: 10.1038/nri2669.
- Background: PubMed 20085707Abramson J, Giraud M, Benoist C, Mathis D. Aire's partners in the molecular control of immunological tolerance. Cell. 2010 Jan 8;140(1):123-35. doi: 10.1016/j.cell.2009.12.030.
- Background: PubMed 23243587Bos R, Marquardt KL, Cheung J, Sherman LA. Functional differences between low- and high-affinity CD8(+) T cells in the tumor environment. Oncoimmunology. 2012 Nov 1;1(8):1239-1247. doi: 10.4161/onci.21285.
- 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.
Steven A Rosenberg, M.D. principal investigator
National Cancer Institute (NCI)
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 Peptide loaded dendritic cell vaccine in people with Melanoma and Gastrointestinal Cancer, run by National Cancer Institute (NCI) 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 25 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 13 Dec 2019. 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 13 Dec 2019). 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?
Percentage of Patients Who Had a Clinical Response (Complete Response (CR) + Partial Response (PR)) to Treatment (time frame: up to 6 months). 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 NCT03300843, which also lists 3 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 13 Dec 2019.