Renal Cell CarcinomaMORENCT02208128
Molecular Determinants for Therapy Response on Renal Cell Carcinoma
A study testing Sunitinib, Pazopanib, Bevacizumab, Everolimus... in people with Renal Cell Carcinoma, run by Heidelberg University at 1 site in Germany.
Trial summary
Aim of the scientific analysis is to find biological factors (biomarkers) allowing a prediction of disease progression and a better choice of therapy. After diagnosis the kidney and the tumor will be removed by standard surgery followed by drug therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Sunitinib, Pazopanib, Bevacizumab, Everolimus...
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum Age: 18 Years Maximum Age: no maximum age
- metastatic lesions easy of access for puncture for specimen storage
- histological subtype: clear-cell renal cancer
- no contraindications against systemic therapy
- indication for systemic therapy given
Who cannot join
- preexisting mental illness
- further active malignancy
- patients with increased risk of bleeding and/or wound healing disorder
- patients who are not legally competent or unable to consent
- contraindication for surgical intervention
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Urological Department of the University Hospital Heidelberg
Heidelberg, 69120
Sascha Pahernik, PD Dr., +49 6221 56 39689, sascha.pahernik@med.uni-heidelberg.de
Sascha Pahernik, PD Dr.
About this study
Aim of the scientific analysis is to find biological factors (biomarkers) allowing a prediction of disease progression and a better choice of therapy. After diagnosis the kidney and the tumor will be removed by standard surgery followed by drug therapy. Within surgery remaining tumor tissue will be used for the scientific analysis. In case of disease progression during the drug treatment the drug therapy will be changed. Before therapy change a small tissue sample will be collected for molecular diagnostics. This will be done by puncture through the skin under local anesthesia. Blood samples taken before surgery and at the time of first and second disease progression will also be used for molecular-biological analysis. As there is no clear recommendation for drug therapy after disease progression this study should serve to determine an individual therapy on the basis of the molecular profile and the molecular changes. As the tumor disease changes and developes resistance to drugs, analysis at the time of disease progression shall identify biological factors which will predict a likelihood response to a specific drugs.
This shall allow to give the patient an individual therapy.
Read the detailed description
Aim of this study is to perform a profound molecular analysis of the tumor before beginning therapy and after failure of the approved targeted first-and second line therapy (standard therapy). The tumor sample will be analyzed by using profound molecular analysis to identify target structures which will predict the efficacy of a specific therapy (substance group)and therefore have a predictive value. The analysis of molecular biomarkers include the genomic sequencing of targeted areas or of the entire DNA of the tumor tissue comparative to the DNA of healthy cells, the measurement of DNA-regulatory elements (methylation, mi-RNA expression, protein expression analytics, functional tumorcell analysis in-vitro, efficacy analysis in cell culture or in animal model) who are supposed to inspect the biological influence of the molecular biomarkers and measurements of free tumor DNA out of the blood.
The response to the established standard therapy in the first and second line will be acquired due to all clinical and radiological established standard parameters. The clinical-radiological response will be correlated with the molecular changes and their changes in therapy process to allow predictive prognosis for a further therapy.
There is no approved clinical standard for third line therapy. However there are further medications approved without any scientific evidence of their efficacy in this therapy situation (third line treatment after failure of first and second line treatment) and for which a response of under 6 weeks is expected.
For these patients the third line therapy will be adjusted to the molecular profiles of the previous therapies. Therefore the oncological history of the noticed marker profiles and the presence of target structures (from whom it is known that they are influenced by certain substances) will be considered.
The therapy will use substances which are approved in general for the treatment of metastatic renal cell cancer.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Sunitinib, Pazopanib, Bevacizumab, Everolimus...
- Keywords
- Renal cell carcinoma, Biomarkers, Molecular modifications
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib, Pazopanib, Bevacizumab, Everolimus...Drug
Also called e.g.Sunitinib, Pazopanib, Bevacizumab, Everolimus...
Clinical standard
| Study group | Role | What they receive |
|---|---|---|
| Receptor-Tyrosinkinase-Inhibitor | No intervention | Guidelines-oriented therapy with approved systemic medications for renal cell carcinoma individually for each patient (Receptor-Tyrosinkinase-Inhibitor) (e.g.Sunitinib, Pazopanib, Bevacizumab, Everolimus, Axitinib, Temsirolimus). With 1.progression turning to second line treatment with one of the upper mentioned medications. Third line therapy due to the individual molecular modifications for each patient. Receives: Drug: Sunitinib, Pazopanib, Bevacizumab, Everolimus... |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression in third line therapy
Progression free survival in third-line therapy ( defined as the time from beginning of the third-line therapy to the date of the first documented progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors criteria assessed by CT/MRI every 12 weeks).
Measured: Approximately 2 years depending on when the failure in third line therapy happens
Secondary outcomes (1)
Identification of preventive biomarkers.
Identification of preventive biomarkers.
Measured: 2weeks in average before surgery and 4 weeks in average after surgery before starting first line treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sascha Pahernil, PD Dr., Principal investigator, University of Heidelberg, Urological Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208128
- Sponsor's protocol ID
- S-539/2013
- Other IDs
- DRKS00006193
- Acronym
- MORE
- Status last verified
- Jul 2014
- First submitted
- 2 Jun 2014
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Determinants for Therapy Response on Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02208128
- Acronym / sponsor ID
- MORE / S-539/2013
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal cell carcinoma, Biomarkers, Molecular modifications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the scientific analysis is to find biological factors (biomarkers) allowing a prediction of disease progression and a better choice of therapy. After diagnosis the kidney and the tumor will be removed by standard surgery followed by drug therapy. Within surgery remaining tumor tissue will be used for the scientific analysis. In case of disease progression during the drug treatment the drug therapy will be changed. Before therapy change a small tissue sample will be collected for molecular diagnostics. This will be done by puncture through the skin under local anesthesia. Blood samples taken before surgery and at the time of first and second disease progression will also be used for molecular-biological analysis. As there is no clear recommendation for drug therapy after disease progression this study should serve to determine an individual therapy on the basis of the molecular profile and the molecular changes. As the tumor disease changes and developes resistance to drugs, analysis at the time of disease progression shall identify biological factors which will predict a likelihood response to a specific drugs.
This shall allow to give the patient an individual therapy.
Detailed description
Aim of this study is to perform a profound molecular analysis of the tumor before beginning therapy and after failure of the approved targeted first-and second line therapy (standard therapy). The tumor sample will be analyzed by using profound molecular analysis to identify target structures which will predict the efficacy of a specific therapy (substance group)and therefore have a predictive value. The analysis of molecular biomarkers include the genomic sequencing of targeted areas or of the entire DNA of the tumor tissue comparative to the DNA of healthy cells, the measurement of DNA-regulatory elements (methylation, mi-RNA expression, protein expression analytics, functional tumorcell analysis in-vitro, efficacy analysis in cell culture or in animal model) who are supposed to inspect the biological influence of the molecular biomarkers and measurements of free tumor DNA out of the blood.
The response to the established standard therapy in the first and second line will be acquired due to all clinical and radiological established standard parameters. The clinical-radiological response will be correlated with the molecular changes and their changes in therapy process to allow predictive prognosis for a further therapy.
There is no approved clinical standard for third line therapy. However there are further medications approved without any scientific evidence of their efficacy in this therapy situation (third line treatment after failure of first and second line treatment) and for which a response of under 6 weeks is expected.
For these patients the third line therapy will be adjusted to the molecular profiles of the previous therapies. Therefore the oncological history of the noticed marker profiles and the presence of target structures (from whom it is known that they are influenced by certain substances) will be considered.
The therapy will use substances which are approved in general for the treatment of metastatic renal cell cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receptor-Tyrosinkinase-Inhibitor | No intervention | Drug: Sunitinib, Pazopanib, Bevacizumab, Everolimus...Guidelines-oriented therapy with approved systemic medications for renal cell carcinoma individually for each patient (Receptor-Tyrosinkinase-Inhibitor) (e.g.Sunitinib, Pazopanib, Bevacizumab, Everolimus, Axitinib, Temsirolimus). With 1.progression turning to second line treatment with one of the upper mentioned medications. Third line therapy due to the individual molecular modifications for each patient. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum Age: 18 Years Maximum Age: no maximum age
- metastatic lesions easy of access for puncture for specimen storage
- histological subtype: clear-cell renal cancer
- no contraindications against systemic therapy
- indication for systemic therapy given
Key exclusion criteria (5 listed)
- preexisting mental illness
- further active malignancy
- patients with increased risk of bleeding and/or wound healing disorder
- patients who are not legally competent or unable to consent
- contraindication for surgical intervention
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 |
|---|---|---|
| Sunitinib, Pazopanib, Bevacizumab, Everolimus...Also: e.g.Sunitinib, Pazopanib, Bevacizumab, Everolimus...Clinical standard | Drug | Receptor-Tyrosinkinase-Inhibitor |
Primary outcome
Time to disease progression in third line therapy
Time frame: Approximately 2 years depending on when the failure in third line therapy happens
Progression free survival in third-line therapy ( defined as the time from beginning of the third-line therapy to the date of the first documented progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors criteria assessed by CT/MRI every 12 weeks).
1 secondary outcome
Identification of preventive biomarkers.
Time frame: 2weeks in average before surgery and 4 weeks in average after surgery before starting first line treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
Related trials for Renal Cell Carcinoma
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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.
Sascha Pahernil, PD Dr. principal investigator
University of Heidelberg, Urological Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunitinib, Pazopanib, Bevacizumab, Everolimus... in people with Renal Cell Carcinoma, run by Heidelberg University at 1 site 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 5 inclusion and 5 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 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Sascha Pahernik, PD Dr. (+49 6221 5639689, sascha.pahernik@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression in third line therapy (time frame: Approximately 2 years depending on when the failure in third line therapy happens). 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 4 Aug 2014.