Head and Neck Squamous Cell CarcinomaPhase 2FOCUSNCT05075122
Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab
A Phase 2 study testing UV1, Sargramostim for Injection and Pembrolizumab injection in people with Head and Neck Squamous Cell Carcinoma, run by Martin-Luther-Universität Halle-Wittenberg at 10 sites in Germany.
Trial summary
The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1) head and neck squamous cell carcinoma. 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?
- UV1, Sargramostim for Injection and Pembrolizumab injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 10 sitesGermany
- Study dates
- 2 Aug 2021to Feb 2025
- Phase
- Phase 2
- 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
- Histologically confirmed diagnosis of a non-resectable recurrent or metastatic head and neck squamous cell carcinoma (not necessarily reconfirmed at time of enrolment)
- At least one measurable tumor lesion as per RECIST v1.1, (Scan not older than 4 weeks before randomization)
- Eligible for pembrolizumab monotherapy (PD-L1 CPS >/= 1% and adequate laboratory parameters for pembrolizumab monotherapy as assessed by the investigator)
- ECOG-performance score 0-2
- Written informed consent obtained according to international guidelines and local laws
- Ability to understand and give informed consent.
- Safe contraception measures for males and females. Procedures with a pearl index of less than 1% apply as safe pregnancy prevention measures.
Who cannot join
- Patients for whom a combination therapy of a checkpoint inhibitor and a chemotherapy is deemed necessary in the opinion of the investigator
- Participation in another interventional study simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed)
- Concurrent malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome
- Active, known, or suspected autoimmune disease requiring systemic treatment.
- A concomitant therapy with systemic immune suppression: use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed; patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible)
- History of severe autoimmune disorder or history of organ transplant
Show all 14Show fewer
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug.
- Significant acute or chronic infections including, among others (test not older than 4 weeks prior to randomization): Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
- Pregnancy or lactation
- (Bacterial) infections requiring systemic antibiotic treatment within 2 weeks prior to first dose of study treatment (depending on group assignment: either prior to first UV1 or prior to first pembrolizumab administration).
- History of allergy or hypersensitivity to study drug or human granulocyte-macrophage colony stimulating factor, yeast-derived products or any constituent of the products
- Receipt of a live vaccine within 30 days prior to start of therapy
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical study and therefore cannot form a rational intention in the light of the facts.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites, 10 recruiting
- Not yet recruiting
Universitätsklinikum Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie
Aachen
- Not yet recruiting
Charité Universitätsmedizin, Comprehensive Cancer Center, Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie
Berlin
- Not yet recruiting
Universitätsklinikum Greifswald, Klinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
Greifswald
- Recruiting
Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin IV
Halle
- Not yet recruiting
Universitätsklinikum Hamburg, Universitäres Cancer Center Hamburg UCCH, Hubertus Wald Tumorzentrum
Hamburg
- Not yet recruiting
Klinikum St. Georg gGmbH
Leipzig
- Recruiting
Universitätsklinikum Leipzig, Klinik und Poliklinik für HNO Heilkunde
Leipzig
- Recruiting
Universitätsklinikum Mainz, III. Medizinische Klinik und Poliklinik
Mainz
- Recruiting
Klinikum Stuttgart, Klinik für Hämatologie, Onkologie und Palliativmedizin
Stuttgart
- Not yet recruiting
Universitätsklinikum Würzburg, Comprehensive Cancer Center Mainfranken
Würzburg
About this study
Official title: Phase 2 Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic PD-L1 Positive (CPS≥1) Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab
The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1) head and neck squamous cell carcinoma. Secondary objectives are to determine the efficacy in terms of overall survival ,objective response rate and duration of response. Moreover, this study will explore patient subgroups most likely deriving benefit from a targeted immunotherapy approach combining a checkpoint inhibitor with a cancer vaccine and help to establish liquid biopsy tumor monitoring in HNSCC.
Read the detailed description
Overall survival of patients with metastatic or recurrent HNSCC has improved over the past decade but remains poor overall. Median overall survival is limited to less than 15 months, with the current standard of care (immune checkpoint blockade with or without chemotherapy). Many patients with HNSCC are frail and therefore cannot tolerate chemotherapy, reducing their treatment options to checkpoint inhibitor. Therefore, the development of effective and tolerable combination regimens is urgently needed, especially in first-line therapy. The FOCUS study will evaluate such a combination regimen in patients with metastatic or recurrent HNSCC. The experimental regimen evaluated in this study will test the first-line standard drug pembrolizumab in combination with the novel UV1 cancer vaccine. In the comparator arm, patients receive pembrolizumab as the standard of care. The aim is to assess whether the addition of UVI can increase the efficacy of the checkpoint inhibitor. Based on currently available data, a decrease in efficacy due to the combination of standard first-line therapy with pembrolizumab is unlikely. The FOCUS study could therefore establish a new 1st-line regimen with increased efficacy and acceptable tolerability, which would need to be compared with the standard of care in a larger phase III trial. Based on the biomarker data from the FOCUS study, a subsequent Phase 3 study would potentially test the regimen only in subpopulations with increased response probability. From the perspective of the individual patient, participants may benefit from the experimental combination through improved efficacy. On the other hand, this is a novel combination study for HNSCC, and there is a risk that efficacy may not improve.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- UV1, Sargramostim for Injection, Pembrolizumab injection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV1Biological
UV1 vaccination (300 μg) UV1 vaccination will be applied in a dense schedule with three vaccinations during one week before initiation of pembrolizumab, followed by 5 additional vaccinations every 3 weeks on d1 of each cycle (5 cycles in total, duration of treatment will be 13 weeks in total, regular EOT at week 14)
Sargramostim for InjectionDrug
75 μg GM-CSF as adjuvant per vaccination. Applied in a dense schedule with three injections during one week before initiation of pembrolizumab, followed by 5 additional injections every 3 weeks on d1 of each cycle (5 cycles in total, duration of treatment will be 13 weeks in total, regular EOT at week 14).
Pembrolizumab injectionDrug
200mg flat dose iv every 3 weeks. Pembrolizumab will be administered beyond the EOT visit at physician discretion until disease progression and up to a maximum of two years (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| Vaccination arm | Experimental | Pembrolizumab flat dose iv every 3 weeks + UV1 vaccination (UV1 plus GM-CSF/Sargramostim as adjuvant per vaccination) Receives: Biological: UV1; Drug: Sargramostim for Injection; Drug: Pembrolizumab injection |
| Calibration arm | Other | Pembrolizumab flat dose iv every 3 weeks Receives: Drug: Pembrolizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate
according to iRECIST
Measured: 6 months after first administration of study medication
Secondary outcomes (7)
Progression free survival
according to iRECIST
Measured: every three months, until progression of disease, maximum 12 months from the date of LPI (last patient in)
Overall survival
Measured: every three months, until death, maximum 12 months from the date of LPI (last patient in)
Objective Response Rate
Complete Remission (CR) + Partial Remission (PR) according to iRECIST
Measured: every three months, until death, maximum 12 months from the date of LPI (last patient in)
Duration of Response
according to iRECIST
Measured: every three months, until death, maximum 12 months from the date of LPI (last patient in)
Rate of immune responses against hTERT peptides
measured by 3H-Thymidine proliferation and IFNgamma ELISPOT assays
Measured: Baseline, up to 8 weeks, time of progression (max. 12 months after LPI)
Rate of clearance of ctDNA from blood on treatment
Measured: Baseline, week 5, week 8 and 1, 3, 6 months after EOT (max. 14 weeks), time of progression (max. 12 months after LPI)
Adverse Events
according to NCI CTC AE v5.0
Measured: 3 months after EOT (maximum 25 weeks after start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start2 Aug 2021
- Primary completionAug 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Ultimovacs ASA, Apotheke der Universitätsmedizin der Johannes Gutenberg-Universität Mainz (Germany), Axel Hinke. CCRC Cancer Clinical Research Consulting (Düsseldorf, Germany
- Responsible party
- Principal investigator, Mascha Binder, MD, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Mascha Binder, MD, Principal investigator, University Medical Center Halle, Department of Hematology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075122
- Sponsor's protocol ID
- KKSH176
- Other IDs
- 2020-005910-17
- Acronym
- FOCUS
- Status last verified
- Mar 2022
- First submitted
- 21 Jul 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paschold L, Schultheiss C, Schmidt-Barbo P, Klinghammer K, Hahn D, Tometten M, Schafhausen P, Blaurock M, Brandt A, Westgaard I, Kowoll S, Stein A, Hinke A, Binder M. Inflammation and limited adaptive immunity predict worse outcomes on immunotherapy in head and neck cancer. NPJ Precis Oncol. 2025 Aug 5;9(1):272. doi: 10.1038/s41698-025-01020-6.
PubMed 40764401Brandt A, Klinghammer K, Schultheiss C, Paschold L, Wickenhauser C, Bauer M, Bergqvist A, Hahn D, Schafhausen P, Tometten M, Blaurock M, Zech HB, Busch CJ, Dietz A, Muller-Richter U, Alt J, Boehm A, Kowoll S, Steighardt J, Lasch A, Westgaard IH, Westhrin M, Stein A, Hinke A, Binder M. UV1 vaccination in pembrolizumab-treated patients with recurrent or metastatic head and neck cancer: A randomized multicenter phase 2 trial. Med. 2025 Jul 11;6(7):100647. doi: 10.1016/j.medj.2025.100647. Epub 2025 Apr 11.
PubMed 40220758Brandt A, Schultheiss C, Klinghammer K, Schafhausen P, Busch CJ, Blaurock M, Hinke A, Tometten M, Dietz A, Muller-Richter U, Hahn D, Alt J, Stein A, Binder M. Tolerability and efficacy of the cancer vaccine UV1 in patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma planned for first-line treatment with pembrolizumab - the randomized phase 2 FOCUS trial. Front Oncol. 2024 Feb 7;14:1283266. doi: 10.3389/fonc.2024.1283266. eCollection 2024.
PubMed 38384801
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic PD-L1 Positive (CPS≥1) Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab
- ClinicalTrials.gov ID
- NCT05075122
- Acronym / sponsor ID
- FOCUS / KKSH176
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Ultimovacs ASA, Apotheke der Universitätsmedizin der Johannes Gutenberg-Universität Mainz (Germany), Axel Hinke. CCRC Cancer Clinical Research Consulting (Düsseldorf, Germany
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 12 Oct 2021 (actual)
- 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 primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1) head and neck squamous cell carcinoma. Secondary objectives are to determine the efficacy in terms of overall survival ,objective response rate and duration of response. Moreover, this study will explore patient subgroups most likely deriving benefit from a targeted immunotherapy approach combining a checkpoint inhibitor with a cancer vaccine and help to establish liquid biopsy tumor monitoring in HNSCC.
Detailed description
Overall survival of patients with metastatic or recurrent HNSCC has improved over the past decade but remains poor overall. Median overall survival is limited to less than 15 months, with the current standard of care (immune checkpoint blockade with or without chemotherapy). Many patients with HNSCC are frail and therefore cannot tolerate chemotherapy, reducing their treatment options to checkpoint inhibitor. Therefore, the development of effective and tolerable combination regimens is urgently needed, especially in first-line therapy. The FOCUS study will evaluate such a combination regimen in patients with metastatic or recurrent HNSCC. The experimental regimen evaluated in this study will test the first-line standard drug pembrolizumab in combination with the novel UV1 cancer vaccine. In the comparator arm, patients receive pembrolizumab as the standard of care. The aim is to assess whether the addition of UVI can increase the efficacy of the checkpoint inhibitor. Based on currently available data, a decrease in efficacy due to the combination of standard first-line therapy with pembrolizumab is unlikely. The FOCUS study could therefore establish a new 1st-line regimen with increased efficacy and acceptable tolerability, which would need to be compared with the standard of care in a larger phase III trial. Based on the biomarker data from the FOCUS study, a subsequent Phase 3 study would potentially test the regimen only in subpopulations with increased response probability. From the perspective of the individual patient, participants may benefit from the experimental combination through improved efficacy. On the other hand, this is a novel combination study for HNSCC, and there is a risk that efficacy may not improve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination arm | Experimental | Biological: UV1, Drug: Sargramostim for Injection, Drug: Pembrolizumab injectionPembrolizumab flat dose iv every 3 weeks + UV1 vaccination (UV1 plus GM-CSF/Sargramostim as adjuvant per vaccination) |
| Calibration arm | Other | Drug: Pembrolizumab injectionPembrolizumab flat dose iv every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of a non-resectable recurrent or metastatic head and neck squamous cell carcinoma (not necessarily reconfirmed at time of enrolment)
- At least one measurable tumor lesion as per RECIST v1.1, (Scan not older than 4 weeks before randomization)
- Eligible for pembrolizumab monotherapy (PD-L1 CPS >/= 1% and adequate laboratory parameters for pembrolizumab monotherapy as assessed by the investigator)
- ECOG-performance score 0-2
- Written informed consent obtained according to international guidelines and local laws
Key exclusion criteria (14 listed)
- Patients for whom a combination therapy of a checkpoint inhibitor and a chemotherapy is deemed necessary in the opinion of the investigator
- Participation in another interventional study simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed)
- Concurrent malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome
- Active, known, or suspected autoimmune disease requiring systemic treatment.
- A concomitant therapy with systemic immune suppression: use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed; patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible)
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 |
|---|---|---|
| UV1UV1 vaccination (300 μg) UV1 vaccination will be applied in a dense schedule with three vaccinations during one week before initiation of pembrolizumab, followed by 5 additional vaccinations every 3 weeks on d1 of each cycle (5 cycles in total, duration of treatment will be 13 weeks in total, regular EOT at week 14) | Biological | Vaccination arm |
| Sargramostim for Injection75 μg GM-CSF as adjuvant per vaccination. Applied in a dense schedule with three injections during one week before initiation of pembrolizumab, followed by 5 additional injections every 3 weeks on d1 of each cycle (5 cycles in total, duration of treatment will be 13 weeks in total, regular EOT at week 14). | Drug | Vaccination arm |
| Pembrolizumab injection200mg flat dose iv every 3 weeks. Pembrolizumab will be administered beyond the EOT visit at physician discretion until disease progression and up to a maximum of two years (standard of care) | Drug | Calibration arm, Vaccination arm |
Primary outcome
Progression free survival rate
Time frame: 6 months after first administration of study medication
according to iRECIST
7 secondary outcomes
Progression free survival
Time frame: every three months, until progression of disease, maximum 12 months from the date of LPI (last patient in)
Overall survival
Time frame: every three months, until death, maximum 12 months from the date of LPI (last patient in)
Objective Response Rate
Time frame: every three months, until death, maximum 12 months from the date of LPI (last patient in)
Duration of Response
Time frame: every three months, until death, maximum 12 months from the date of LPI (last patient in)
Rate of immune responses against hTERT peptides
Time frame: Baseline, up to 8 weeks, time of progression (max. 12 months after LPI)
Rate of clearance of ctDNA from blood on treatment
Time frame: Baseline, week 5, week 8 and 1, 3, 6 months after EOT (max. 14 weeks), time of progression (max. 12 months after LPI)
Adverse Events
Time frame: 3 months after EOT (maximum 25 weeks after start of treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 40764401Paschold L, Schultheiss C, Schmidt-Barbo P, Klinghammer K, Hahn D, Tometten M, Schafhausen P, Blaurock M, Brandt A, Westgaard I, Kowoll S, Stein A, Hinke A, Binder M. Inflammation and limited adaptive immunity predict worse outcomes on immunotherapy in head and neck cancer. NPJ Precis Oncol. 2025 Aug 5;9(1):272. doi: 10.1038/s41698-025-01020-6.
- Derived from this study: PubMed 40220758Brandt A, Klinghammer K, Schultheiss C, Paschold L, Wickenhauser C, Bauer M, Bergqvist A, Hahn D, Schafhausen P, Tometten M, Blaurock M, Zech HB, Busch CJ, Dietz A, Muller-Richter U, Alt J, Boehm A, Kowoll S, Steighardt J, Lasch A, Westgaard IH, Westhrin M, Stein A, Hinke A, Binder M. UV1 vaccination in pembrolizumab-treated patients with recurrent or metastatic head and neck cancer: A randomized multicenter phase 2 trial. Med. 2025 Jul 11;6(7):100647. doi: 10.1016/j.medj.2025.100647. Epub 2025 Apr 11.
- Derived from this study: PubMed 38384801Brandt A, Schultheiss C, Klinghammer K, Schafhausen P, Busch CJ, Blaurock M, Hinke A, Tometten M, Dietz A, Muller-Richter U, Hahn D, Alt J, Stein A, Binder M. Tolerability and efficacy of the cancer vaccine UV1 in patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma planned for first-line treatment with pembrolizumab - the randomized phase 2 FOCUS trial. Front Oncol. 2024 Feb 7;14:1283266. doi: 10.3389/fonc.2024.1283266. eCollection 2024.
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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.
Mascha Binder, MD principal investigator
University Medical Center Halle, Department of Hematology and Oncology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UV1, Sargramostim for Injection and Pembrolizumab injection in people with Head and Neck Squamous Cell Carcinoma, run by Martin-Luther-Universität Halle-Wittenberg at 10 sites in Germany.
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 14 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mascha Binder, MD (0049 345 557 ext. 2054, mascha.binder@uk-halle.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival rate (time frame: 6 months after first administration of study medication). 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 NCT05075122, 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 9 Mar 2022.