CancerPhase 2NCT05289856
Cabozantinib in Combination With Avelumab in Patients Refractory to Standard Chemotherapy With Advanced Neuroendocrine Neoplasias G3 (NEN G3)
A Phase 2 study testing combination of Avelumab and Cabozantinib in people with Cancer, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
Trial summary
The purpose of the CaboAveNEC trial is to investigate the clinical activity and safety of Cabozantinib in combination with avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- combination of Avelumab and Cabozantinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- 28 Mar 2022to 3 Jan 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
- Age ≥ 18 years
- Histologically proven neuroendocrine neoplasia NEN G3 (WHO 2010/2019)
- One block or 20 slides (cut at 4 microns) of archival tumor tissue to perform central pathological review and biomarker assessment and for translational research
- No curative option available
- Progression within 9 months before study initiation and after at least one chemotherapy (platinum based chemotherapy or STZ/TEM/DTIC based chemotherapy)
- Presence of measurable disease as per RECIST1.1 criteria
Show all 17Show fewer
- Adequate organ and bone barrow functionn:
- 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: Women of child-bearing potential (WOCBP) and men who are able to father a child, willing to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of study participation and for at least 30 days for female and 90 days for male patients after last dose of avelumab and at least for 4 months after last dose of cabozantinib
- ECOG Performance Status 0 - 1
- Life expectancy of at least 12 weeks according to the assessment of the investigator
- 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 TKI or immune therapy
- Neuroendocrine neoplasias that are potentially curable by surgery
- Major surgery within 4 weeks before first dose of study medication. Complete wound healing must be observed at least 10 days prior to enrollment.
- Patients who are at increased risk for severe haemorrhage
Show all 29Show fewer
- TACE, TAE, SIRT or PRRT within 8 weeks before first dose of study medication
- Patients pretreated with Interferon as last treatment line prior to study entry
- Concurrent anticancer treatment after 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).
- Concurrent treatment with strong inducers of cytochrome P450 3A4 (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's wort) and strong inhibitors of cytochrome P450 3A4 (eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, and ritonavir), warfarin (due to its high protein bound)
- 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)
- Active SARS-CoV-2 infection (detected via positive PCR test)
- Autoimmune disease: Severe active autoimmune disease that requires immunomodulatory therapy. Patients with diabetes type I, vitiligo, psoriasis, autoimmune thyroid disease not requiring immunosuppressive treatment are eligible.
- Persisting toxicity related to prior therapy (NCI CTCAE v.5.0 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 before the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines.
- Hypersensitivity to study drugs: Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3) and lactose contained in cabozantinib tablets
- 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), uncontrolled arterial hypertension or serious cardiac arrhythmia requiring medication.
- Clinical significant hematemesis or hemoptysis
- Medical or psychological conditions that would jeopardise an adequate and orderly completion of the trial
- Patients, who are legally institutionalized.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg
Heidelberg, 69120
I. Medizinische Klinik und Poliklinik, Endokrinologie und Stoffwechselerkrankungen, Universitätsmedizin Mainz
Mainz, 55131
About this study
Official title: A Phase II, Open-label, Multicenter Trial to Investigate the Clinical Activity and Safety of Cabozantinib in Combination With Avelumab in Patients Refractory to Standard Chemotherapy With Advanced Neuroendocrine Neoplasias G3 (NEN G3).
The purpose of the CaboAveNEC trial is to investigate the clinical activity and safety of Cabozantinib in combination with avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3).
Read the detailed description
According to the WHO classification of 2010, Neuroendocrine neoplasms (NEN) are graded according to the Ki67 proliferation index and grouped into neuroendocrine Tumors (NET) Grade 1 (NET G1, Ki67 <3%), NET G2 (Ki67 3-20%), and neuroendocrine Carcinomas (NEC) (G3, Ki67 >20%). However, since the WHO 2017/2019 classification the group of gastrointestinal neuroendocrine tumors with a Ki67 ≥20% (NEN G3) is subdivided according to their morphology into highly proliferative differentiated NET G3 and 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.
The prognosis of patients with metastatic NEN 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" undifferentiated 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 NEN G3 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 40 % 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.
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.
In the ongoing phase II trial of the investigator (AveNEC, EudraCT No: 2016-004373-40), which is the largest immunotherapy trial in patients with NEN G3, the clinical activity and safety of the PD-L1 inhibitor avelumab is evaluated in 60 patients with advanced, metastatic NEN G3 progressive after chemotherapy. According to the interim analysis presented at ASCO 2019 a clinically meaningful response was seen in 27 % of patients with a significant longer progression free survival (mean PFS 33.5 vs 7.7 weeks) and overall survival (> 60 weeks mean not reached vs 22.4 weeks) as compared to the non-responders.
Cabozantinib is a multikinase inhibitor of MET, VEGFR, AXL and RET which is currently being used very successfully in medullary thyroid carcinoma (MTC), which is a differentiated neuroendocrine neoplasia, in advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC).
In addition to its TKI activity, there is strong evidence that Cabozantinib modulates the tumor immune microenvironment leading to a synergistic efficacy in combination with a checkpoint inhibitor therapy.
There is an especially strong rationale for a combination therapy of the potent antiangiogenic TKI Cabozantinib with the checkpoint inhibitor Avelumab in NEN G3. Both drugs have demonstrated efficacy and safety in combination therapy studies of a checkpoint inhibitor and an antiangiogenic TKI in a variety of tumors and both drugs in monotherapy have shown clinical relevant antitumor efficacy in NEN.
- Conditions
- Cancer
- Being tested
- combination of Avelumab and Cabozantinib
- Keywords
- neuroendocrine neoplasias (NEN), NET G3, NEC G3, avelumab, cabozantinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of Avelumab and CabozantinibDrug
Also called Bavencio, Cabometyx
Cabozantinib 40 mg daily PO in combination with Avelumab at a dose of 800 mg as a 1h intravenous (i.v.) infusion every two weeks (q2w) until disease progression (PD), unacceptable toxicity, or any criterion for treatment withdrawalis met, for a maximum of 12 months
| Study group | Role | What they receive |
|---|---|---|
| combination of Avelumab and Cabozantinib | Experimental | 800 mg Avelumab every 2 weeks and 40 mg Cabozantinib daily Receives: Drug: combination of Avelumab and Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR: CR, PR, SD)
Disease control rate (DCR: CR, PR, SD) according to iRECIST after 16 weeks from start of treatment until documented disease progression (PD)
Measured: 16 weeks
Secondary outcomes (12)
Disease control rate (DCR: CR, PR, SD)
Disease control rate (DCR: CR, PR, SD) according to iRECIST
Measured: week 8, week 24, week 48
Objective response rate (ORR)
Objective response rate (ORR) according to iRECIST
Measured: week 8, week 16, week 24, week 48
Best overall response (BOR)
Best overall response (BOR) according to iRECIST
Measured: week 8, week 16, week 24, week 48
Duration of disease control (DDC)
Duration of disease control (DDC) according to iRECIST
Measured: week 48
Time to response (TTR)
Time to response (TTR) according to iRECIST
Measured: week 48
Progression-free survival time (PFS)
Progression-free survival time (PFS) according to iRECIST
Measured: week 48
Evaluation of tumor response according to RECIST1.1
Evaluation of tumor response according to RECIST1.1
Measured: week 8, week 16, week 24, week 48
Overall survival (OS)
Overall survival (OS)
Measured: week 48, week 96
Quality of life (QoL)
Quality of life (QoL) assessed by European Organisation for Research and Treatment of Cancer Quality of life questionnaire (EORTC QLQ-C30); Scale 0 - 100; higher levels indicate better quality of life
Measured: week 8, week 16, week 24, week 48
Adverse events
Number, severity, and duration of treatment-emergent AEs according to NCI-CTCAE v5.0
Measured: week 48
Dose change of study drugs
Dose change of study drugs
Measured: week 48
Treatment interruption or termination
Treatment interruption or termination of study drugs due to adverse events
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start28 Mar 2022
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Responsible party
- Principal investigator, Prof. Dr. Matthias M. Weber, Johannes Gutenberg University Mainz
- Investigators
- Matthias M Weber, MD, Principal investigator, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, I. Medizinische Klinik und Poliklinik, Abteilung Endokrinologie und Stoffwechselkrankheiten, D-55131 Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289856
- Sponsor's protocol ID
- CaboAveNEC
- Other IDs
- 2021-000986-34
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2022
- Last updated
- 1 Sep 2026
- 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 1 Sep 2026. 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 Cabozantinib in Combination With Avelumab in Patients Refractory to Standard Chemotherapy With Advanced Neuroendocrine Neoplasias G3 (NEN G3).
- ClinicalTrials.gov ID
- NCT05289856
- Acronym / sponsor ID
- CaboAveNEC
- Conditions
- Cancer
- Keywords
- neuroendocrine neoplasias (NEN), NET G3, NEC G3, avelumab, cabozantinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Ipsen, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 22 Mar 2022 (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 CaboAveNEC trial is to investigate the clinical activity and safety of Cabozantinib in combination with avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3).
Detailed description
According to the WHO classification of 2010, Neuroendocrine neoplasms (NEN) are graded according to the Ki67 proliferation index and grouped into neuroendocrine Tumors (NET) Grade 1 (NET G1, Ki67 <3%), NET G2 (Ki67 3-20%), and neuroendocrine Carcinomas (NEC) (G3, Ki67 >20%). However, since the WHO 2017/2019 classification the group of gastrointestinal neuroendocrine tumors with a Ki67 ≥20% (NEN G3) is subdivided according to their morphology into highly proliferative differentiated NET G3 and 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.
The prognosis of patients with metastatic NEN 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" undifferentiated 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 NEN G3 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 40 % 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.
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.
In the ongoing phase II trial of the investigator (AveNEC, EudraCT No: 2016-004373-40), which is the largest immunotherapy trial in patients with NEN G3, the clinical activity and safety of the PD-L1 inhibitor avelumab is evaluated in 60 patients with advanced, metastatic NEN G3 progressive after chemotherapy. According to the interim analysis presented at ASCO 2019 a clinically meaningful response was seen in 27 % of patients with a significant longer progression free survival (mean PFS 33.5 vs 7.7 weeks) and overall survival (> 60 weeks mean not reached vs 22.4 weeks) as compared to the non-responders.
Cabozantinib is a multikinase inhibitor of MET, VEGFR, AXL and RET which is currently being used very successfully in medullary thyroid carcinoma (MTC), which is a differentiated neuroendocrine neoplasia, in advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC).
In addition to its TKI activity, there is strong evidence that Cabozantinib modulates the tumor immune microenvironment leading to a synergistic efficacy in combination with a checkpoint inhibitor therapy.
There is an especially strong rationale for a combination therapy of the potent antiangiogenic TKI Cabozantinib with the checkpoint inhibitor Avelumab in NEN G3. Both drugs have demonstrated efficacy and safety in combination therapy studies of a checkpoint inhibitor and an antiangiogenic TKI in a variety of tumors and both drugs in monotherapy have shown clinical relevant antitumor efficacy in NEN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination of Avelumab and Cabozantinib | Experimental | Drug: combination of Avelumab and Cabozantinib800 mg Avelumab every 2 weeks and 40 mg Cabozantinib daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Histologically proven neuroendocrine neoplasia NEN G3 (WHO 2010/2019)
- One block or 20 slides (cut at 4 microns) of archival tumor tissue to perform central pathological review and biomarker assessment and for translational research
- No curative option available
- Progression within 9 months before study initiation and after at least one chemotherapy (platinum based chemotherapy or STZ/TEM/DTIC based chemotherapy)
Key exclusion criteria (29 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 TKI or immune therapy
- Neuroendocrine neoplasias that are potentially curable by surgery
- Major surgery within 4 weeks before first dose of study medication. Complete wound healing must be observed at least 10 days prior to enrollment.
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 |
|---|---|---|
| combination of Avelumab and CabozantinibAlso: Bavencio, CabometyxCabozantinib 40 mg daily PO in combination with Avelumab at a dose of 800 mg as a 1h intravenous (i.v.) infusion every two weeks (q2w) until disease progression (PD), unacceptable toxicity, or any criterion for treatment withdrawalis met, for a maximum of 12 months | Drug | combination of Avelumab and Cabozantinib |
Primary outcome
Disease control rate (DCR: CR, PR, SD)
Time frame: 16 weeks
Disease control rate (DCR: CR, PR, SD) according to iRECIST after 16 weeks from start of treatment until documented disease progression (PD)
12 secondary outcomes
Disease control rate (DCR: CR, PR, SD)
Time frame: week 8, week 24, week 48
Objective response rate (ORR)
Time frame: week 8, week 16, week 24, week 48
Best overall response (BOR)
Time frame: week 8, week 16, week 24, week 48
Duration of disease control (DDC)
Time frame: week 48
Time to response (TTR)
Time frame: week 48
Progression-free survival time (PFS)
Time frame: week 48
Evaluation of tumor response according to RECIST1.1
Time frame: week 8, week 16, week 24, week 48
Overall survival (OS)
Time frame: week 48, week 96
Quality of life (QoL)
Time frame: week 8, week 16, week 24, week 48
Adverse events
Time frame: week 48
Dose change of study drugs
Time frame: week 48
Treatment interruption or termination
Time frame: week 48
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 1 Sep 2026.
- 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
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, I. Medizinische Klinik und Poliklinik, Abteilung Endokrinologie und Stoffwechselkrankheiten, D-55131 Mainz, Germany
2 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 combination of Avelumab and Cabozantinib in people with Cancer, run by Johannes Gutenberg University Mainz at 2 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 17 inclusion and 29 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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: CR, PR, SD) (time frame: 16 weeks). 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 1 Sep 2026.