Soft Tissue Sarcoma AdultPhase 2PROPANENCT05961761
Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients
A Phase 2 study testing Propranolol and Pembrolizumab in people with Soft Tissue Sarcoma Adult and Angiosarcoma, run by Niels Junker at 4 sites in 3 countries.
Trial summary
The goal of this phase 2 clinical trial is to test efficacy and tolerability of combining propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma Adult, Angiosarcoma, Undifferentiated Pleomorphic Sarcoma
- What is being tested?
- Propranolol and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 17 Aug 2021to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- Histologically confirmed diagnosis of unresectable locally advanced or metastatic Angiosarcoma or Undifferentiated Pleomorphic Sarcoma, who has progressed/failed to provide clinical benefit on first line standard chemotherapy.
- Age ≥18 years
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of ≤2 at the time of enrollment.
- Evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
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- Available material from archived formalin-fixed paraffin-embedded tumor tissue obtained within 3 months of study enrollment for biomarker related studies. If not sufficient or available, a newly obtained core or excisional biopsy of a tumor lesion may be performed.
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1 x 10⁹/L
- Platelet count ≥ 75 x 10⁹/L
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol/L)
- Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 5 x ULN
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (using the Cockcroft-Gault formula)
- Women of childbearing potential (WOCBP): Agreement to use contraceptive methods with a failure rate of < 1 % per year during the treatment period and for at least 120 days after the treatment. Safe contraceptive methods for women are birth control pills, intrauterine device, contraceptive injection, contraceptive implant,contraceptive patch or contraceptive vaginal ring.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during the treatment period and for at least 120 days after the treatment.
- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
Who cannot join
- Have an anticipated life expectancy of <3 months.
- Moderate to severe degree of bronchial asthma or chronic obstructive pulmonary disease.
- Acute or non-stable congestive heart failure
- Any other condition listed as contraindication for treatment with propranolol according to SPC
- Have received any previous systemic therapy targeting the PD-1/PDL-1 signaling pathway or other immune checkpoint inhibitors.
- Have received propranolol within 4 weeks prior to treatment.
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- Prior to study day one received radiation therapy, chemotherapy or targeted small molecule therapy within 2 weeks and/or monoclonal antibody treatment within 4 weeks.
- Not recovered from the effects of previously administered agents
- Clinically active or unstable CNS metastases as assessed by the treating physician
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
- Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism Inclusion criteria
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- Histologically confirmed diagnosis of unresectable locally advanced or metastatic Angiosarcoma or Undifferentiated Pleomorphic Sarcoma, who has progressed/failed to provide clinical benefit on first line standard chemotherapy.
- Age ≥18 years
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of ≤2 at the time of enrollment.
- Evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- Available material from archived formalin-fixed paraffin-embedded tumor tissue obtained within 3 months of study enrollment for biomarker related studies. If not sufficient or available, a newly obtained core or excisional biopsy of a tumor lesion may be performed.
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1 x 10⁹/L
- Platelet count ≥ 75 x 10⁹/L
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol/L)
- Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 5 x ULN
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (using the Cockcroft-Gault formula)
- Women of childbearing potential (WOCBP): Agreement to use contraceptive methods with a failure rate of < 1 % per year during the treatment period and for at least 120 days after the treatment. Safe contraceptive methods for women are birth control pills, intrauterine device, contraceptive injection, contraceptive implant,contraceptive patch or contraceptive vaginal ring.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during the treatment period and for at least 120 days after the treatment.
- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
- Have an anticipated life expectancy of <3 months.
- Moderate to severe degree of bronchial asthma or chronic obstructive pulmonary disease.
- Acute or non-stable congestive heart failure
- Any other condition listed as contraindication for treatment with propranolol according to SPC
- Have received any previous systemic therapy targeting the PD-1/PDL-1 signaling pathway or other immune checkpoint inhibitors.
- Have received propranolol within 4 weeks prior to treatment.
- Prior to study day one received radiation therapy, chemotherapy or targeted small molecule therapy within 2 weeks and/or monoclonal antibody treatment within 4 weeks.
- Not recovered from the effects of previously administered agents
- Clinically active or unstable CNS metastases as assessed by the treating physician
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
- Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Allergies and Adverse Drug Reaction
- History of allergy to study drug components
- History of severe hypersensitivity reaction to any monoclonal antibody
- WOCBP who are pregnant or breastfeeding
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus, 8200
Ninna Aggerholm Pedersen, MD, PhD, Msc, aggerholm@oncology.au.dk
- Recruiting
Herlev Gentofte Hospital
Herlev, 2730
Niels Junker, MD, PhD, +4538682973, Niels.Junker@regionh.dk
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Kjetil Boye, MD, PhD, kjetil.boye@ous-hf.no
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm
Andri Papakonstantinou, MD, PhD, andri.papakonstantinou@regionstockholm.se
About this study
Official title: An Open Label Phase 2 Study on Propranolol and Pembrolizumab in Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma - a Scandinavian Sarcoma Group Collaboration
The goal of this phase 2 clinical trial is to test efficacy and tolerability of combining propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma. The main questions aims to answer:
- Primary: determine the progression-free survival rate (PFSR) at 3 months
Read more
Secondary: determine the objective response rate (ORR), duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS). Ensure the safety and tolerability, Determine Quality of Life (QoL)
- Exploratory: Characterize the TME
Participants will be asked to ensure
- Baseline biopsy and further optional biopsies
- Treatment propranolol 40 mg BID and pembrolizumab 2 mg/kg Q3 weeks
- Evaluation, blood counts, QoL and blood samples for biomarkers according to schedule
Read the detailed description
Soft tissue sarcomas (STS) are mesenchymal derived tumors consisting of more than 50 subtypes, showing high metastatic features in approximately 50% of patients with intermediate and high-grade tumors. In spite of optimizing sequence of conventional systemic treatments with chemotherapy and tyrosine kinase inhibitors with an increase in overall survival from 12 to 18 months, the prognosis has not changed and is still a dismal 8% overall survival at 5 years. After four decades doxorubicin is still first line treatment as no new drugs has proven more effective and/or less toxic. Thus, new treatment modalities are needed.
Angiosarcomas (AS) and Undifferentiated Pleomorphic Sarcoma (UPS), comprising approximately 2% and 10% of STS respectively, are by definition high grade sarcomas characterized by an aggressive course. In the non-resectable advanced and metastatic setting treatment options are limited with short term palliative intent with median overall survival (OS) < 12 months. Patients are often elderly and with co-morbidities, increasing risk of severe toxicity from chemotherapy leading to significant deterioration of Quality of Life. New therapeutic options are needed.
Emerging results on immune modulating therapy with immune checkpoint inhibitors (ICI), have shown promising signals of potential benefit in certain subtypes of STS, especially in UPS and AS.
In tumors, neovascularization facilitate hypoxia, glucose deprivation and increased VEGF production leading to an immune suppressive tumor microenvironment (TME). This can in part be reverted by anti-angiogenic therapy including multitarget tyrosine kinase inhibitors. A proposed novel approach for targeting angiogenesis and potential immune modulatory mechanisms is through beta-adrenergic receptor (βAR) signaling. Preclinical data support combining βAR blockade with propranolol in combination with anti PD-1, and recently a phase 1 study showed the combination propranolol and pembrolizumab was well tolerated in melanoma patients.
This study is an open label, Simon two-stage single arm phase 2 study of pembrolizumab and propranolol in two separate cohorts. Patients will receive pembrolizumab 2 mg/kg every 3 weeks and propranolol 40 mg x2 daily until progression, unacceptable toxicity or patient withdrawal for a maximum of two years.
Up to 40 patients will be included in each separate cohort. Up to 18 patients in stage 1 and up to 22 patients in stage 2.
The primary objective is to determine progression-free survival rate (PFSR) at 3 months by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
The secondary objectives are to determine objective response rate (ORR) and duration of Response (DOR) using RECIST v 1.1, PFS and OS. Ensure safety and tolerability according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and determine Quality of Life (QoL) using the 30 item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) questionnaire
The explorative objective is to characterize the TME, immune cells and markers both in tumors and in peripheral blood.
- Being tested
- Propranolol, Pembrolizumab
- Keywords
- Immunotherapy, Propranolol, Pembrolizumab, PD-1 inhibitor, Sarcoma
- Medical subject headings
- Hemangiosarcoma, Histiocytoma, Malignant Fibrous, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Betablocker
propranolol 40 mg x2 daily
PembrolizumabDrug
Also called anti PD-1
pembrolizumab 2 mg/kg every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Propranolol + pembrolizumab | Experimental | pembrolizumab 2 mg/kg every 3 weeks and propranolol 40 mg x2 daily until progression, unacceptable toxicity or patient withdrawal for a maximum of two years. Receives: Drug: Propranolol; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate
Determine the progression-free survival rate (PFSR) at 3 months by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: 3 months
Secondary outcomes (6)
Objective response rate
Determine the objective response rate (ORR) using RECIST v 1.1
Measured: Approximately 6 months
Duration of Response
Duration of Response (DOR) measured as time from response to progression according to RECIST v 1.1 or death.
Measured: Up to 2 years
Progression Free Survival
Progression Free Survival (PFS) according to RECIST v 1.1
Measured: Up to 2 years
Overall Survival
Overall Survival (OS).
Measured: Up to 2 years
Safety of the treatment
Toxicity will be assessed by Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. Adverse events (AEs) of interest include any grade 3 or 4 treatment-related AEs leading to discontinuation.
Safety is measured through the proportion of treated patients whose worst AEs of interest occurred within safety follow up after the last treatment.
Measured: Up to 2 years
Quality of Life assessment
Determine Quality of Life (QoL) EORTC QLQ-C30
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start17 Aug 2021
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma AdultStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A Simon´s optimum two-stage design
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niels Junker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Niels Junker, Herlev and Gentofte Hospital
- Investigators
- Niels Junker, MD, PhD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961761
- Sponsor's protocol ID
- SA2115
- Acronym
- PROPANE
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 2 Study on Propranolol and Pembrolizumab in Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma - a Scandinavian Sarcoma Group Collaboration
- ClinicalTrials.gov ID
- NCT05961761
- Acronym / sponsor ID
- PROPANE / SA2115
- Keywords
- Immunotherapy, Propranolol, Pembrolizumab, PD-1 inhibitor, Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Niels JunkerUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Oslo University Hospital, Karolinska University Hospital
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Jul 2023 (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 goal of this phase 2 clinical trial is to test efficacy and tolerability of combining propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma. The main questions aims to answer:
- Primary: determine the progression-free survival rate (PFSR) at 3 months
Secondary: determine the objective response rate (ORR), duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS). Ensure the safety and tolerability, Determine Quality of Life (QoL)
- Exploratory: Characterize the TME
Participants will be asked to ensure
- Baseline biopsy and further optional biopsies
- Treatment propranolol 40 mg BID and pembrolizumab 2 mg/kg Q3 weeks
- Evaluation, blood counts, QoL and blood samples for biomarkers according to schedule
Detailed description
Soft tissue sarcomas (STS) are mesenchymal derived tumors consisting of more than 50 subtypes, showing high metastatic features in approximately 50% of patients with intermediate and high-grade tumors. In spite of optimizing sequence of conventional systemic treatments with chemotherapy and tyrosine kinase inhibitors with an increase in overall survival from 12 to 18 months, the prognosis has not changed and is still a dismal 8% overall survival at 5 years. After four decades doxorubicin is still first line treatment as no new drugs has proven more effective and/or less toxic. Thus, new treatment modalities are needed.
Angiosarcomas (AS) and Undifferentiated Pleomorphic Sarcoma (UPS), comprising approximately 2% and 10% of STS respectively, are by definition high grade sarcomas characterized by an aggressive course. In the non-resectable advanced and metastatic setting treatment options are limited with short term palliative intent with median overall survival (OS) < 12 months. Patients are often elderly and with co-morbidities, increasing risk of severe toxicity from chemotherapy leading to significant deterioration of Quality of Life. New therapeutic options are needed.
Emerging results on immune modulating therapy with immune checkpoint inhibitors (ICI), have shown promising signals of potential benefit in certain subtypes of STS, especially in UPS and AS.
In tumors, neovascularization facilitate hypoxia, glucose deprivation and increased VEGF production leading to an immune suppressive tumor microenvironment (TME). This can in part be reverted by anti-angiogenic therapy including multitarget tyrosine kinase inhibitors. A proposed novel approach for targeting angiogenesis and potential immune modulatory mechanisms is through beta-adrenergic receptor (βAR) signaling. Preclinical data support combining βAR blockade with propranolol in combination with anti PD-1, and recently a phase 1 study showed the combination propranolol and pembrolizumab was well tolerated in melanoma patients.
This study is an open label, Simon two-stage single arm phase 2 study of pembrolizumab and propranolol in two separate cohorts. Patients will receive pembrolizumab 2 mg/kg every 3 weeks and propranolol 40 mg x2 daily until progression, unacceptable toxicity or patient withdrawal for a maximum of two years.
Up to 40 patients will be included in each separate cohort. Up to 18 patients in stage 1 and up to 22 patients in stage 2.
The primary objective is to determine progression-free survival rate (PFSR) at 3 months by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
The secondary objectives are to determine objective response rate (ORR) and duration of Response (DOR) using RECIST v 1.1, PFS and OS. Ensure safety and tolerability according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and determine Quality of Life (QoL) using the 30 item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) questionnaire
The explorative objective is to characterize the TME, immune cells and markers both in tumors and in peripheral blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Simon´s optimum two-stage design
| Arm | Type | Receives |
|---|---|---|
| Propranolol + pembrolizumab | Experimental | Drug: Propranolol, Drug: Pembrolizumabpembrolizumab 2 mg/kg every 3 weeks and propranolol 40 mg x2 daily until progression, unacceptable toxicity or patient withdrawal for a maximum of two years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- Histologically confirmed diagnosis of unresectable locally advanced or metastatic Angiosarcoma or Undifferentiated Pleomorphic Sarcoma, who has progressed/failed to provide clinical benefit on first line standard chemotherapy.
- Age ≥18 years
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of ≤2 at the time of enrollment.
Key exclusion criteria (44 listed)
- Have an anticipated life expectancy of <3 months.
- Moderate to severe degree of bronchial asthma or chronic obstructive pulmonary disease.
- Acute or non-stable congestive heart failure
- Any other condition listed as contraindication for treatment with propranolol according to SPC
- Have received any previous systemic therapy targeting the PD-1/PDL-1 signaling pathway or other immune checkpoint inhibitors.
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 |
|---|---|---|
| PropranololAlso: Betablockerpropranolol 40 mg x2 daily | Drug | Propranolol + pembrolizumab |
| PembrolizumabAlso: anti PD-1pembrolizumab 2 mg/kg every 3 weeks | Drug | Propranolol + pembrolizumab |
Primary outcome
Progression-free survival rate
Time frame: 3 months
Determine the progression-free survival rate (PFSR) at 3 months by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
6 secondary outcomes
Objective response rate
Time frame: Approximately 6 months
Duration of Response
Time frame: Up to 2 years
Progression Free Survival
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Safety of the treatment
Time frame: Up to 2 years
Quality of Life assessment
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
Niels Junker, MD, PhD principal investigator
Herlev and Gentofte Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol and Pembrolizumab in people with Soft Tissue Sarcoma Adult and Angiosarcoma, run by Niels Junker at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 44 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: looking for participants now, as of the sponsor's last update on 27 Jul 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 Denmark, Norway, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niels Junker, MD, PhD (+4538682973, Niels.Junker@regionh.dk), 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: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.