CancerPhase 2AveNECNCT03352934
Avelumab Treatment in Patients With Neuroendocrine Carcinomas (NEC G3) Progressive After Chemotherapy
A Phase 2 study testing Avelumab in people with Cancer, run by Johannes Gutenberg University Mainz at 4 sites in Germany.
Trial summary
The purpose of the AveNEC trial is to investigate the clinical activity and safety of avelumab in patients with NEC G3 (WHO 2010), including "NET G3" who are progressive after first line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesGermany
- Study dates
- 7 Dec 2017to 18 Feb 2022
- 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
- Male or female subjects aged ≥ 18 years
- Histologically proven neuroendocrine neoplasia NEC G3 (WHO 2010)
- One block or 20 slides (cut at 4 microns) of archival tumor tissue, if available, to perform biomarker assessment
- No curative option available
- Progressive disease within 9 months before study Initiation and after at least one chemotherapy (platinum based chemotherapy or STZ/TEM/DTIC based chemotherapy in NET G3)
- Presence of measurable disease as per RECIST1.1 criteria
Show all 16Show fewer
- Physiologic function:
- Hematologic: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused)
- Hepatic: total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 × ULN for subjects with documented metastatic disease to the liver)
- Renal: estimated creatinine clearance ≥ 60 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
- Pregnancy and contraception:
- Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential.
- Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days for female and 90 days for male patients after avelumab treatment if the risk of conception exists.
- ECOG Performance Status 0 - 2
- Written informed consent: Signed and dated informed consent of the subject must be available before start of any specific trial procedures
- Ability of subject to understand nature, importance and individual consequences of clinical trial.
Who cannot join
- Merkel Cell carcinoma (MCC) or small cell lung cancer (SCLC)
- Typical or Atypical Carcinoid of the lung with a Ki67 < 20%
- Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints)
- Neuroendocrine tumors that are potentially curable by surgery
- Major surgery within 4 weeks of initiation of study medication.
- TACE, TAE, SIRT or PRRT within 3 months of starting study treatment
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- Patients pretreated with Interferon as last treatment line prior to study entry
- Concurrent anticancer treatment after the start of trial treatment (e.g., cyto-reductive therapy, TKI therapy, mTOR inhibitor therapy, radiotherapy [with the exception of palliative radiotherapy], immune therapy, or cytokine therapy except for erythropoietin or use of any investigational drug).
- Immunosuppressants: Current use of immunosuppressive medication, EXCEPT for the following:
- intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
- Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Prior organ transplantation, including allogeneic stem cell transplantation
- Active infection requiring systemic therapy
- HIV/AIDS: Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Hepatitis: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
- Autoimmune disease: Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable
- Pregnancy or lactation
- Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Vaccination: Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
- Hypersensitivity to study drug: Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
- Cardiovascular disease: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Participation in other clinical trials during the present clinical trial or within the last 30 days or five terminal phase half-lives of the drug whichever is longer, prior to baseline (this also includes investigational formulation of market products).
- Medical or psychological conditions that would jeopardise an adequate and orderly completion of the trial.
- Patients, who are legally institutionalized
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Poliklinik für Innere Medizin I Universitätsklinikum Halle
Halle, D-06120
Nationales Centrum für Tumorerkrankungen Universitätsklinikum Heidelberg
Heidelberg, D-69120
Schwerpunkt Endokrinologie und Stoffwechselerkrankungen Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, D-55131
Klinik für Innere Medizin, Abteilung Gastroenterologie Universitätsklinikum Gießen und Marburg
Marburg, D35043
About this study
Official title: A Phase II, Open-label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab in Patients With Advanced, Metastatic High Grade Neuroendocrine Carcinomas NEC G3 (WHO 2010) Progressive After Chemotherapy
The purpose of the AveNEC trial is to investigate the clinical activity and safety of avelumab in patients with NEC G3 (WHO 2010), including "NET G3" who are progressive after first line chemotherapy.
Read the detailed description
According to the WHO classification of 2010, Neuroendocrine neoplasms (NEN) are divided into well to moderately differentiated neuroendocrine tumors (NET), which are graded depending on their proliferation status into NET G1 (Ki67 index < 2%) and NET G2 (Ki67 2-20%), and into the poorly differentiated high grade neuroendocrine Carcinomas (NEC G3, ki67 > 20%), which - depending on their morphology - are subdivided into small cell as well as large cell NECs. The vast majority (60-90%) of patients with high grade NEC are metastasized at the time of diagnosis with distant metastases present in approximately two third of the patients.
G3 neuroendocrine neoplasia according to the WHO classification of 2010 are not a homogenous entity. Based on clinical and morphological criteria a differentiated subgroup with a Ki67 in the lower proliferative range (usually between 20-55%) which is unofficially termed "NET G3", can be subdivided from the more aggressive and undifferentiated "classical" NEC G3.
The prognosis of patients with metastatic NEC G3 is poor, and median overall survival has been reported to be 5 months with a 2-year survival rate of 11 % in the SEER data base for gastrointestinal NEC. In two large series of GEP-NEC, median survival was 12-19 months for patients with best available therapy (mainly platinum based chemotherapy) and as short as 1 month for those receiving only best supportive therapy. In contrast to the "classical" NEC G3 with a poorly differentiated morphology and a Ki 67 > 55%, NET G3 typically do not respond as well to a platinum based chemotherapy but a have a somewhat better prognosis with a 4-months longer median survival as compared to classical NEC G3. Therefore, according to current guidelines other treatment options like temozolomide based chemotherapy may be considered as a first line therapy in patients with differentiated "NET G3" .
There is a strong and unmet medical need for a novel and effective second line treatment option for these highly aggressive and rapidly progressing tumors. Considering the lack of any other established therapeutic option and the very limited efficacy of alternative second or third line chemotherapy in patients with NEC G3 (WHO 2010) who are progressive after a first-line chemotherapy, the availability of a novel therapeutic option with a significant clinical benefit (SD; PR; CR) in at least 30 % of the patients and with tolerable side effects would represent an important and clinical highly relevant break through in the treatment of these aggressive tumors.
There is a strong rationale for investigating PD-1/PD-L1 blockade in NEC G3 (WHO 2010). High grade NEC as well as LCNEC of the lung show a high mutational load, what is associated with a strong immunogenicity and a better response to an anti-PDL1/PD1 immunotherapy, and increased PDL1 expression has been demonstrated in high grade NEC. In intermediate NET the degree of T-cell tumor infiltration was associated with recurrence and survival and in a study with 80 patients with bronchopulmonary NEN including high grade NEC the expression of PD-L1 and PD-1 was associated with a worse prognosis. Evidence from phase 2 to 3 trials shows antiproliferative efficacy of an anti-PDL1/PD1 immunotherapy in high grade NECs. Furthermore, Merkel cell carcinomas, which are classified as high grade neuroendocrine tumors, are sucessfully treated with Avelumab.
Avelumab is a fully human antibody that binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effect of PD-L1 on anti-tumor CD8+ T cells, resulting in restoration of cytotoxic T cell response.
Given the important role of PD-L1 in the suppression of T-cell responses, and the mode of action of avelumab which blocks the interaction between PD-L1 and its receptors, avelumab is being developed as a potential therapy for subjects with various tumors.
It is assumed that at least 20-30 % of patients with progressive disease after at least one first line chemotherapy will show a significant and clinically highly relevant benefit which is defined as an objective tumor response with complete remission (CR), partial remission (PR) or stable disease (SD) according to RECIST1.1.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Also called MSB0010718C, anti-PD-L1
Avelumab will be administered as intravenous infusion at 10 mg/kg once every two weeks until documented disease progression (PD), unacceptable toxicity, or any criterion for treatment withdrawal are met.
| Study group | Role | What they receive |
|---|---|---|
| Avelumab | Experimental | 10 mg/kg Avelumab every 2 weeks Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate (DCR) after 16 weeks of avelumab treatment
The primary endpoint is the disease control rate (DCR) after 16 weeks of avelumab treatment. DCR is defined as the percentage of subjects with a confirmed reduction in tumor size compared to baseline (complete response (CR) and partial response (PR)) as well as fulfilling the criteria for stable disease (SD) according RECIST1.1.
Measured: 16 weeks
Secondary outcomes (9)
disease control rate (DCR) on other assessments
Disease control rate (DCR) on other assessments. DCR is the proportion of patients with complete response, partial response and stable disease according to RECIST1.1.
Measured: 8, 24, 36, 48, 60 weeks
Objective response rate (ORR) on every assessment
Objective response rate (ORR) on every assessment. ORR is the proportion of patients with complete response (CR) or partial response (PR) according to RECIST1.1.
Measured: 8, 16, 24, 36, 48, 60 weeks
Best overall response (BOR)
Best overall response (BOR). BOR is recorded from the start of the treatment until disease progression/recurrence according to RECIST1.1.
Measured: 8, 16, 24, 36, 48, 60 weeks
Duration of disease control
Duration of disease control: Duration of disease control is defined as the time from the first disease control (CR, PR, SD) to progression of disease (PD) according to RECIST1.1.
Measured: up to 1 year
Time to response (TTR)
Time to response (TTR): TTR is the time from the first dose of trial medication to the first documentation of either complete response (CR) or partial response (PR) according to RECIST1.1.
Measured: up to 1 year
Median Progression-free survival time (PFS)
Median Progression-free survival time (PFS). The time from first dose of trial medication to first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first.
Measured: up to 2 years
Overall survival (OS) and survival rate after 1 and 2 years
Overall survival (OS) and survival rate after 1 and 2 years: Overall survival is defined as the time from first dose of trial medication to date of death due to any cause. Survival rate is defined as rate of subjects surviving for at least 1 year or 2 years after first application of trial medication.
Measured: up to 2 years
Quality of life (QoL)
Quality of life (QoL) assessed by the EORTC QLQ-C30 questionnaire on Screening/Baseline, during Treatment on every assessment, on End of Treatment and on Safety FU visit
Measured: 0, 8, 16, 24, 36, 48, 52, 60 weeks
Incidence of adverse events (AEs)
Reporting of number and frequency of adverse Events (AEs) during treatment with avelumab and until Safety Follow
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start7 Dec 2017
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
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 CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Principal investigator, Prof. Dr. Matthias M. Weber, Johannes Gutenberg University Mainz
- Investigators
- Matthias M Weber, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352934
- Sponsor's protocol ID
- 2016-007
- Other IDs
- 2016-004373-40, 2016
- Acronym
- AveNEC
- Status last verified
- Feb 2022
- First submitted
- 3 Nov 2017
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohrmann L, Rostock L, Werner M, Oles M, Arnold JS, Paramasivam N, Johrens K, Rupp L, Schmitz M, Richter D, Uhrig S, Frohlich M, Hutter B, Hullein J, Jahn A, Arlt M, Mohrmann EE, Hanf D, Gieldon L, Kreutzfeldt S, Heilig CE, Teleanu MV, Lipka DB, Beck K, Baude-Muller A, Mock A, Jelas I, Rieke DT, Wiesweg M, Brandts C, Boerries M, Illert AL, Desuki A, Kindler T, Krackhardt AM, Westphalen CB, Christopoulos P, Apostolidis L, Stenzinger A, Allgauer M, Neumann O, Kerle IA, Horak P, Heining C, Grosch H, Schrock E, Hubschmann D, Frohling S, Glimm H. Genomic landscape and molecularly informed therapy in thymic carcinoma and other advanced thymic epithelial tumors. Med. 2025 Jun 13;6(6):100612. doi: 10.1016/j.medj.2025.100612. Epub 2025 Mar 18.
PubMed 40107270
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab in Patients With Advanced, Metastatic High Grade Neuroendocrine Carcinomas NEC G3 (WHO 2010) Progressive After Chemotherapy
- ClinicalTrials.gov ID
- NCT03352934
- Acronym / sponsor ID
- AveNEC / 2016-007
- Conditions
- Cancer
- Keywords
- avelumab, anti-PD-L1, neuroendocrine tumor, NET G3, neuroendocrine carcinoma, NEC G3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 24 Nov 2017 (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 purpose of the AveNEC trial is to investigate the clinical activity and safety of avelumab in patients with NEC G3 (WHO 2010), including "NET G3" who are progressive after first line chemotherapy.
Detailed description
According to the WHO classification of 2010, Neuroendocrine neoplasms (NEN) are divided into well to moderately differentiated neuroendocrine tumors (NET), which are graded depending on their proliferation status into NET G1 (Ki67 index < 2%) and NET G2 (Ki67 2-20%), and into the poorly differentiated high grade neuroendocrine Carcinomas (NEC G3, ki67 > 20%), which - depending on their morphology - are subdivided into small cell as well as large cell NECs. The vast majority (60-90%) of patients with high grade NEC are metastasized at the time of diagnosis with distant metastases present in approximately two third of the patients.
G3 neuroendocrine neoplasia according to the WHO classification of 2010 are not a homogenous entity. Based on clinical and morphological criteria a differentiated subgroup with a Ki67 in the lower proliferative range (usually between 20-55%) which is unofficially termed "NET G3", can be subdivided from the more aggressive and undifferentiated "classical" NEC G3.
The prognosis of patients with metastatic NEC G3 is poor, and median overall survival has been reported to be 5 months with a 2-year survival rate of 11 % in the SEER data base for gastrointestinal NEC. In two large series of GEP-NEC, median survival was 12-19 months for patients with best available therapy (mainly platinum based chemotherapy) and as short as 1 month for those receiving only best supportive therapy. In contrast to the "classical" NEC G3 with a poorly differentiated morphology and a Ki 67 > 55%, NET G3 typically do not respond as well to a platinum based chemotherapy but a have a somewhat better prognosis with a 4-months longer median survival as compared to classical NEC G3. Therefore, according to current guidelines other treatment options like temozolomide based chemotherapy may be considered as a first line therapy in patients with differentiated "NET G3" .
There is a strong and unmet medical need for a novel and effective second line treatment option for these highly aggressive and rapidly progressing tumors. Considering the lack of any other established therapeutic option and the very limited efficacy of alternative second or third line chemotherapy in patients with NEC G3 (WHO 2010) who are progressive after a first-line chemotherapy, the availability of a novel therapeutic option with a significant clinical benefit (SD; PR; CR) in at least 30 % of the patients and with tolerable side effects would represent an important and clinical highly relevant break through in the treatment of these aggressive tumors.
There is a strong rationale for investigating PD-1/PD-L1 blockade in NEC G3 (WHO 2010). High grade NEC as well as LCNEC of the lung show a high mutational load, what is associated with a strong immunogenicity and a better response to an anti-PDL1/PD1 immunotherapy, and increased PDL1 expression has been demonstrated in high grade NEC. In intermediate NET the degree of T-cell tumor infiltration was associated with recurrence and survival and in a study with 80 patients with bronchopulmonary NEN including high grade NEC the expression of PD-L1 and PD-1 was associated with a worse prognosis. Evidence from phase 2 to 3 trials shows antiproliferative efficacy of an anti-PDL1/PD1 immunotherapy in high grade NECs. Furthermore, Merkel cell carcinomas, which are classified as high grade neuroendocrine tumors, are sucessfully treated with Avelumab.
Avelumab is a fully human antibody that binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effect of PD-L1 on anti-tumor CD8+ T cells, resulting in restoration of cytotoxic T cell response.
Given the important role of PD-L1 in the suppression of T-cell responses, and the mode of action of avelumab which blocks the interaction between PD-L1 and its receptors, avelumab is being developed as a potential therapy for subjects with various tumors.
It is assumed that at least 20-30 % of patients with progressive disease after at least one first line chemotherapy will show a significant and clinically highly relevant benefit which is defined as an objective tumor response with complete remission (CR), partial remission (PR) or stable disease (SD) according to RECIST1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avelumab | Experimental | Drug: Avelumab10 mg/kg Avelumab every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female subjects aged ≥ 18 years
- Histologically proven neuroendocrine neoplasia NEC G3 (WHO 2010)
- One block or 20 slides (cut at 4 microns) of archival tumor tissue, if available, to perform biomarker assessment
- No curative option available
- Progressive disease within 9 months before study Initiation and after at least one chemotherapy (platinum based chemotherapy or STZ/TEM/DTIC based chemotherapy in NET G3)
Key exclusion criteria (26 listed)
- Merkel Cell carcinoma (MCC) or small cell lung cancer (SCLC)
- Typical or Atypical Carcinoid of the lung with a Ki67 < 20%
- Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints)
- Neuroendocrine tumors that are potentially curable by surgery
- Major surgery within 4 weeks of initiation of study medication.
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 |
|---|---|---|
| AvelumabAlso: MSB0010718C, anti-PD-L1Avelumab will be administered as intravenous infusion at 10 mg/kg once every two weeks until documented disease progression (PD), unacceptable toxicity, or any criterion for treatment withdrawal are met. | Drug | Avelumab |
Primary outcome
disease control rate (DCR) after 16 weeks of avelumab treatment
Time frame: 16 weeks
The primary endpoint is the disease control rate (DCR) after 16 weeks of avelumab treatment. DCR is defined as the percentage of subjects with a confirmed reduction in tumor size compared to baseline (complete response (CR) and partial response (PR)) as well as fulfilling the criteria for stable disease (SD) according RECIST1.1.
9 secondary outcomes
disease control rate (DCR) on other assessments
Time frame: 8, 24, 36, 48, 60 weeks
Objective response rate (ORR) on every assessment
Time frame: 8, 16, 24, 36, 48, 60 weeks
Best overall response (BOR)
Time frame: 8, 16, 24, 36, 48, 60 weeks
Duration of disease control
Time frame: up to 1 year
Time to response (TTR)
Time frame: up to 1 year
Median Progression-free survival time (PFS)
Time frame: up to 2 years
Overall survival (OS) and survival rate after 1 and 2 years
Time frame: up to 2 years
Quality of life (QoL)
Time frame: 0, 8, 16, 24, 36, 48, 52, 60 weeks
Incidence of adverse events (AEs)
Time frame: 60 weeks
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 25 Feb 2022.
- Derived from this study: PubMed 40107270Mohrmann L, Rostock L, Werner M, Oles M, Arnold JS, Paramasivam N, Johrens K, Rupp L, Schmitz M, Richter D, Uhrig S, Frohlich M, Hutter B, Hullein J, Jahn A, Arlt M, Mohrmann EE, Hanf D, Gieldon L, Kreutzfeldt S, Heilig CE, Teleanu MV, Lipka DB, Beck K, Baude-Muller A, Mock A, Jelas I, Rieke DT, Wiesweg M, Brandts C, Boerries M, Illert AL, Desuki A, Kindler T, Krackhardt AM, Westphalen CB, Christopoulos P, Apostolidis L, Stenzinger A, Allgauer M, Neumann O, Kerle IA, Horak P, Heining C, Grosch H, Schrock E, Hubschmann D, Frohling S, Glimm H. Genomic landscape and molecularly informed therapy in thymic carcinoma and other advanced thymic epithelial tumors. Med. 2025 Jun 13;6(6):100612. doi: 10.1016/j.medj.2025.100612. Epub 2025 Mar 18.
- 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.
Matthias M Weber, MD principal investigator
Johannes Gutenberg University Mainz
4 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 Avelumab in people with Cancer, run by Johannes Gutenberg University Mainz at 4 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 16 inclusion and 26 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 25 Feb 2022. 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 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?
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?
disease control rate (DCR) after 16 weeks of avelumab treatment (time frame: 16 weeks). 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 NCT03352934, 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 25 Feb 2022.