Head and Neck Squamous Cell CarcinomaNCT02999646
Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC
A study testing MVX-ONCO-1 in people with Head and Neck Squamous Cell Carcinoma, run by Maxivax SA at 4 sites in Switzerland.
Trial summary
The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1 in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead tumor cells from the patient itself and genetically modified cells within a capsule. The whole treatment takes 9 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- MVX-ONCO-1
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 25 Jul 2018to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Written informed consent according to ICH/GCP regulations before pre-registration
- Histologically confirmed diagnosis of head and neck squamous carcinoma (oral cavity, pharynx, larynx), Stage III/IV in recurrent or metastatic stage. Patients with local relapse for whom a curative treatment is available cannot be enrolled. Furthermore, all patients should have no other therapeutic option left.
- At least one line of prior anticancer therapy for recurrent or metastatic disease. Patients with locally advanced disease experiencing local relapse within 6 months of last dose of curative intended, platinum-based chemo-radiation with or without prior surgery can also be included.
- Primary tumor and/or metastasis amenable for partial/total surgery or tap
- Measurable or evaluable disease according to RECIST 1.1 criteria
- Patients age ≥ 18 years
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- WHO performance status 0-2
- Adequate hematological values: neutrophils ≥1x10^9/L, platelets ≥70x10^9/L
- Adequate hepatic function: bilirubin ≤2 x ULN; AST and ALT and AP ≤2.5 x ULN (except for patients with liver metastasis: ≤5 x ULN)
- Adequate renal function (creatinine clearance >40mL/min/1.73m^2, calculated according to the corrected formula of Cockcroft-Gault
- Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant after pre-registration, during trial treatment and during the 6 months thereafter. A negative blood pregnancy test before inclusion into the trial is required for all women with child-bearing potential
- Men agree not to father a child during trial treatment and during 6 months thereafter
- Primary tumor and/or metastasis amenable for partial/total surgery or tap and subsequent cell harvest > 26x10^6 cells
- Measurable or evaluable disease according to RECIST 1.1 criteria
- WHO performance status 0-2
- Baseline QoL forms have been completed
- Adequate hematological values: neutrophils ≥1x10^9/L, platelets ≥70x10^9/L
- Adequate hepatic function: bilirubin ≤2 x ULN; AST and ALT and AP ≤ 2.5 x ULN (except for patients with liver metastasis: ≤5 x ULN)
- Adequate renal function (creatinine clearance >40 mL/min/1.73m^2, calculated according to the corrected formula of Cockcroft-Gault
- Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant after registration, during trial treatment, and during the 6 months thereafter. A negative blood pregnancy
Who cannot join
- Known or suspected CNS metastases or active leptomeningeal disease
- History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of T1-2 prostate cancer Gleason score <6 (PSA<10 ng/mL), adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- Participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks of the pre-registration
- Concomitant use of other anti-cancer drugs
- Planned radiotherapy (other than symptom control)
- Severe or uncontrolled cardiovascular disease uncontrolled hypertension (sustained systolic blood pressure > 150 mm Hg and/or diastolic > 100 mm Hg despite antihypertensive therapy)
Show all 23Show fewer
- History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to pre-registration
- Any history of HIV
- Known history of HTLV-1, HTLV-2, or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment
- Known severe allergy to reagents in the study product (MVX-ONCO-1)
- Systemic disease other than cancer that is not controlled by approved medication
- Patient with active autoimmune disease
- Chronic immunosuppressive treatment exceeding 20 mg/day of prednisone or an equivalent corticosteroid. Note: In acute situations prednison exceeding 20mg/day or equivalent(day is allowed during 7 days)
- Women who are pregnant or breast feeding
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
- Known or suspected CNS metastases or active leptomeningeal disease
- Concomitant use of other anti-cancer drugs
- Planned radiotherapy (other than symptom control)
- Any one full cycle of anti-cancer chemotherapy treatment in the 3 preceding weeks of the registration
- Systemic disease other than cancer, that is not controlled by approved medication
- Chronic immunosuppressive treatment exceeding 20 mg/day of prednisone or an equivalent corticosteroid. Note: In acute situations prednisone exceeding 20 mg/day or equivalent is allowed during 7 days
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
- Women who are pregnant or breastfeeding
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
HUG Hôpitaux Universitaires Genève
Geneva, 1211
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, CH-1011
Kantonsspital St. Gallen
Sankt Gallen, CH-9007
Universitätsspital Zürich
Zurich, 8091
About this study
Official title: Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced Head and Neck Squamous Cell Carcinoma. A Single Arm, Open Label, Multicenter Phase II Trial.
The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1 in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead tumor cells from the patient itself and genetically modified cells within a capsule. The whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9 the capsules are removed again. The patients are then followed-up for 5 years.
Read the detailed description
Patients with advanced HNSCC after platinum-based palliative chemotherapy have a poor prognosis, with no well-defined standard treatment and a survival between 6 to 9 months.
MVX-ONCO-1 is a patient specific, cell-based, active immunotherapy, where the patient's immune response to tumor cells is stimulated and/or increased by triggering an immune response against the patients' cancer cells.
Rationale for this trial is:
- HNSCC: there is a clear medical need in this patient population,
- Relapsing HNSCC often have accessible tumor tissue,
- HNSCC is considered an immunogenic tumor.
This phase II study is a first step towards a potentially innovative immunotherapy for HNSCC.
MVX-ONCO-1 is composed of:
- An immune-modulator (GM-CSF: granulocyte-macrophage colony stimulating factor) released from an immuno-protected, encapsulated, allogeneic, genetically modified cell line (MVX-1), and
- Irradiated, autologous tumor cells as source of antigen.
Each treatment consists of two macrocapsules containing the MVX-1 cell line implanted subcutaneously and lethally irradiated autologous tumor cells injected subcutaneously. Eligible patients will receive a treatment once weekly starting on week 1 for 4 weeks followed by two additional treatments 2 weeks apart (total 6 treatments over 8 weeks). Each pair of macrocapsules is removed after 1 week, and the last implanted capsules are removed in week 9. The patients are then followed-up for 5 years.
The project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 880194.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- MVX-ONCO-1
- Keywords
- head and neck squamous cell carcinoma, cancer, HNSCC, immunotherapy, MVX-ONCO-1
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVX-ONCO-1Other
Autologous cells: 1 vial containing 4x10^6 irradiated tumor cells Capsules: 2 biocompatible capsules loaded with 8x10^5 MVX-1 cells
| Study group | Role | What they receive |
|---|---|---|
| MVX-ONCO-1 | Experimental | MVX-ONCO-1 vaccine treatment once weekly starting on week 1 for 4 weeks followed by two additional treatments 2 weeks apart (total 6 treatments over 8 weeks). Each treatment consists of two macrocapsules containing the MVX-1 cell line and lethally irradiated autologous tumor cells. Receives: Other: MVX-ONCO-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival at 26 weeks (OS)
The primary endpoint of the trial is Overall Survival (OS) at 26 weeks defined as percentage of patients alive 26 weeks from registration. Patients who are lost to follow-up with a date they were last known to be alive less than 26 weeks after registration will be counted as failures for this endpoint.
Measured: at 26 weeks from registration
Secondary outcomes (12)
Time to subsequent therapy (TST)
defined as time from registration until documented start of subsequent therapy. Patients who did not start a subsequent therapy will be censored at the last date they were known to be alive
Measured: assessed within 5 years
Duration of response (DOR)
defined as time from the date when a patient first meets the criteria for complete response (CR) or partial response (PR) until documented radiologic progression, relapse, or death due to disease progression, whichever occurs first. Patients not having an event at the time of analysis and patients starting a new anticancer therapy in the absence of an event will be censored at the date of their last tumor assessment showing non-progression before starting a new treatment. DOR will only be analyzed in the subgroup of patients achieving CR or PR during trial treatment based on RECIST 1.1.
Measured: assessed within 5 years
Objective response rate (ORR)
defined as the proportion of patients having CR or PR at the respective time point after registration plus/minus 1 week at week 6, 13, 26, and plus/minus 2 weeks at week 39 and 52 after registration.
The response rate will be analyzed based on RECIST 1.1. CR and PR will only be counted if the response is confirmed at least 4 weeks later
Measured: at 6, 13, 26, 39 and 52 weeks
Disease control rate (DCR)
defined as the proportion of patients having CR, PR, or stable disease (SD) at the respective time point after registration plus/minus 1 week at week 6, 13, 26, and plus/minus 2 weeks at week 39 and 52 after registration. The disease control rate will be analyzed based on RECIST 1.1. CR and PR will only be counted if the response is confirmed at least 4 weeks later.
Measured: at 6, 13, 26, 39 and 52 weeks
Best overall response
defined as best response achieved at any time during or after the trial treatment before starting a new anticancer treatment. Best overall response will be analyzed based on RECIST 1.1. CR and PR will only be counted if the response is confirmed at least 4 weeks later.
Measured: assessed within 5 years
Objective response according to iRECIST (iOR)
defined as any complete response (CR/iCR) or partial response (PR/iPR) according to RECIST1.1 or iRECIST criteria achieved before new anti-cancer treatment is given. Any patient with CR/iCR or PR/iPR as best observed response under trial treatment will be considered as a success; otherwise they will be considered as a failure. Patients without any tumor assessment or with non-evaluable response (NE) under trial treatment will be considered as failures for this endpoint.
Measured: at 6, 13, 26, 39 and 52 weeks
Progression Free Survival (PFS)
defined as the time from registration until progression according to RECIST 1.1 or death from any cause, whichever occurs first. Patients not having an event at the time of analysis and patients starting a new anticancer therapy in the absence of an event will be censored at the date of their last tumor assessment showing non-progression before starting a new treatment.
Measured: assessed within 5 years
Progression-free survival according to iRECIST (iPFS)
defined as the time from registration until disease progression according to iRECIST criteria (iPD) or death due to any reason, whichever occurs first.
Measured: assessed within 5 years
PFS at 6, 13, 26, 39, and 52 weeks
will be estimated using the Kaplan-Meier estimator for PFS at the respective time point after registration plus/minus 1 week at week 6, 13, 26, and plus/minus 2 weeks at week 39 and 52 after registration.
Measured: at 6, 13, 26, 39, and 52 weeks
OS
defined as time from registration until death from any cause. Patients which are still alive will be censored at the date they were last known to be alive.
Measured: assessed within 5 years
PFS under the first subsequent treatment
defined as the time from start of the first subsequence treatment until progression according to RECIST 1.1 or death from any cause, whichever occurs first. Patients not having an event at the time of analysis and patients starting next line of anticancer therapy in the absence of an event will be censored at the date of their last tumor assessment showing non-progression before starting new treatment.
Measured: assessed within 5 years
Adverse and serious adverse events
All adverse events (AE) will be assessed according to NCI CTCAE v4.0
Measured: assessed within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start25 Jul 2018
- Primary completion25 Jan 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- antitumor immunization MVX-ONCO-1
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxivax SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Olivier Michielin, Prof, Study chair, CHUV Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999646
- Sponsor's protocol ID
- SAKK 11/16
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2016
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez E, Vernet R, Urwyler M, Von Rohr O, Charrier E, Belkouch MC, Saingier V, Courtout F, DeVito C, Ancrenaz V, Dulguerov N, Karenovics W, Grogg J, Renaux J, Gobat K, Muller G, Brezina T, Rordorf T, Joerger M, Michielin O, Villard J, Mach N. Overall survival of recurrent/metastatic head & neck squamous cell carcinoma patients progressing after >/= 1 line of systemic therapy, treated with MVX-ONCO-1, a novel, first in class cell encapsulation-based immunotherapy: results of SAKK 11/16, a phase IIa trial. Exp Hematol Oncol. 2025 Aug 31;14(1):113. doi: 10.1186/s40164-025-00703-x.
PubMed 40887652
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced Head and Neck Squamous Cell Carcinoma. A Single Arm, Open Label, Multicenter Phase II Trial.
- ClinicalTrials.gov ID
- NCT02999646
- Acronym / sponsor ID
- SAKK 11/16
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck squamous cell carcinoma, cancer, HNSCC, immunotherapy, MVX-ONCO-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maxivax SAIndustry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1 in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead tumor cells from the patient itself and genetically modified cells within a capsule. The whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9 the capsules are removed again. The patients are then followed-up for 5 years.
Detailed description
Patients with advanced HNSCC after platinum-based palliative chemotherapy have a poor prognosis, with no well-defined standard treatment and a survival between 6 to 9 months.
MVX-ONCO-1 is a patient specific, cell-based, active immunotherapy, where the patient's immune response to tumor cells is stimulated and/or increased by triggering an immune response against the patients' cancer cells.
Rationale for this trial is:
- HNSCC: there is a clear medical need in this patient population,
- Relapsing HNSCC often have accessible tumor tissue,
- HNSCC is considered an immunogenic tumor.
This phase II study is a first step towards a potentially innovative immunotherapy for HNSCC.
MVX-ONCO-1 is composed of:
- An immune-modulator (GM-CSF: granulocyte-macrophage colony stimulating factor) released from an immuno-protected, encapsulated, allogeneic, genetically modified cell line (MVX-1), and
- Irradiated, autologous tumor cells as source of antigen.
Each treatment consists of two macrocapsules containing the MVX-1 cell line implanted subcutaneously and lethally irradiated autologous tumor cells injected subcutaneously. Eligible patients will receive a treatment once weekly starting on week 1 for 4 weeks followed by two additional treatments 2 weeks apart (total 6 treatments over 8 weeks). Each pair of macrocapsules is removed after 1 week, and the last implanted capsules are removed in week 9. The patients are then followed-up for 5 years.
The project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 880194.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- antitumor immunization MVX-ONCO-1
| Arm | Type | Receives |
|---|---|---|
| MVX-ONCO-1 | Experimental | Other: MVX-ONCO-1MVX-ONCO-1 vaccine treatment once weekly starting on week 1 for 4 weeks followed by two additional treatments 2 weeks apart (total 6 treatments over 8 weeks). Each treatment consists of two macrocapsules containing the MVX-1 cell line and lethally irradiated autologous tumor cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent according to ICH/GCP regulations before pre-registration
- Histologically confirmed diagnosis of head and neck squamous carcinoma (oral cavity, pharynx, larynx), Stage III/IV in recurrent or metastatic stage. Patients with local relapse for whom a curative treatment is available cannot be enrolled. Furthermore, all patients should have no other therapeutic option left.
- At least one line of prior anticancer therapy for recurrent or metastatic disease. Patients with locally advanced disease experiencing local relapse within 6 months of last dose of curative intended, platinum-based chemo-radiation with or without prior surgery can also be included.
- Primary tumor and/or metastasis amenable for partial/total surgery or tap
- Measurable or evaluable disease according to RECIST 1.1 criteria
Key exclusion criteria (23 listed)
- Known or suspected CNS metastases or active leptomeningeal disease
- History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of T1-2 prostate cancer Gleason score <6 (PSA<10 ng/mL), adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- Participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks of the pre-registration
- Concomitant use of other anti-cancer drugs
- Planned radiotherapy (other than symptom control)
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 |
|---|---|---|
| MVX-ONCO-1Autologous cells: 1 vial containing 4x10^6 irradiated tumor cells Capsules: 2 biocompatible capsules loaded with 8x10^5 MVX-1 cells | Other | MVX-ONCO-1 |
Primary outcome
Overall Survival at 26 weeks (OS)
Time frame: at 26 weeks from registration
The primary endpoint of the trial is Overall Survival (OS) at 26 weeks defined as percentage of patients alive 26 weeks from registration. Patients who are lost to follow-up with a date they were last known to be alive less than 26 weeks after registration will be counted as failures for this endpoint.
12 secondary outcomes
Time to subsequent therapy (TST)
Time frame: assessed within 5 years
Duration of response (DOR)
Time frame: assessed within 5 years
Objective response rate (ORR)
Time frame: at 6, 13, 26, 39 and 52 weeks
Disease control rate (DCR)
Time frame: at 6, 13, 26, 39 and 52 weeks
Best overall response
Time frame: assessed within 5 years
Objective response according to iRECIST (iOR)
Time frame: at 6, 13, 26, 39 and 52 weeks
Progression Free Survival (PFS)
Time frame: assessed within 5 years
Progression-free survival according to iRECIST (iPFS)
Time frame: assessed within 5 years
PFS at 6, 13, 26, 39, and 52 weeks
Time frame: at 6, 13, 26, 39, and 52 weeks
OS
Time frame: assessed within 5 years
PFS under the first subsequent treatment
Time frame: assessed within 5 years
Adverse and serious adverse events
Time frame: assessed within 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 40887652Fernandez E, Vernet R, Urwyler M, Von Rohr O, Charrier E, Belkouch MC, Saingier V, Courtout F, DeVito C, Ancrenaz V, Dulguerov N, Karenovics W, Grogg J, Renaux J, Gobat K, Muller G, Brezina T, Rordorf T, Joerger M, Michielin O, Villard J, Mach N. Overall survival of recurrent/metastatic head & neck squamous cell carcinoma patients progressing after >/= 1 line of systemic therapy, treated with MVX-ONCO-1, a novel, first in class cell encapsulation-based immunotherapy: results of SAKK 11/16, a phase IIa trial. Exp Hematol Oncol. 2025 Aug 31;14(1):113. doi: 10.1186/s40164-025-00703-x.
- 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.
Olivier Michielin, Prof study chair
CHUV Lausanne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MVX-ONCO-1 in people with Head and Neck Squamous Cell Carcinoma, run by Maxivax SA at 4 sites in Switzerland.
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 20 inclusion and 23 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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 at 26 weeks (OS) (time frame: at 26 weeks from registration). 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 NCT02999646, 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 28 Sep 2023.