Renal Cancer MetastaticPhase 2NCT05215470
CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy
A Phase 2 study testing Nivolumab and Ipilimumab in people with Renal Cancer Metastatic, run by Hospital das Clínicas de Ribeirão Preto at 1 site in Brazil.
Trial summary
The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer Metastatic
- What is being tested?
- Nivolumab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Jan 2022to 30 Nov 2026
- 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
- Renal cell carcinoma patient: histological confirmed clear cell tumor;
- First-line metastatic treatment;
- Stage IV with at least one measured lesion;
- Fresh-frozen primary tumor tissue available;
- No previous immunotherapy or tyrosine kinase inhibitor treatment;
- All International Metastatic RCC Database Consortium (IMDC) Risk Score;
- Karnofsky Performance Scale (KPS) >=70;
- >=18 years old.
Who cannot join
- History of a known or suspected autoimmune disease;
- Any condition requiring systemic treatment with corticosteroids;
- Creatinine clearance < 40mL/min;
- Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) > 5 x ULN;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto - USP
Ribeirão Preto, São Paulo, 14040-900
About this study
Official title: CLARA: Characterization of Somatic and Germline Mechanisms That Impact the Immunotherapy Treatment and Prognosis of Patients With Renal Cancer
The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).
Read the detailed description
One hundred newly diagnosticated stage IV RCC patients will be recruited in the Ribeirao Preto Medical School.
Patients will be treated with immune checkpoint inhibitors (ICI) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment.
Patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival).
Fresh-frozen primary tumor tissue will be collected for somatic genomic characterization.
Blood DNA will be genotyped for the identification of common germline variation, as well as ancestry determination.
- Conditions
- Renal Cancer Metastatic
- Being tested
- Nivolumab, Ipilimumab
- Keywords
- Renal Cancer, Nivolumab, Ipilimumab, Immunotherapy, molecular profiling
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Nivolumab is called an anti-PD-1 (Programmed Cell Death Ligand 1) or a checkpoint inhibitor and is an antibody (a type of human protein) designed to allow the body's own immune system to destroy tumors
IpilimumabDrug
Also called Yervoy
Ipilimumab is called an anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) and is a type of antibody that works to prevent the body's immune system from stopping to fight a specific cancer
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab+Ipilimumab | Experimental | Nivolumab IV 3mg/kg 3/3w + Ipilimumab 1mg/kg 3/3w 4 doses, followed by Nivolumab IV 480mg 4/4w until progression, toxicity, or up to 2 years of use. Receives: Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 3 years
Progression-free survival
Measured: 2 years
Secondary outcomes (1)
Overall Response Rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start18 Jan 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cancer MetastaticStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital das Clínicas de Ribeirão Preto
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Leandro M Colli, MD PhD, Hospital das Clínicas de Ribeirão Preto
- Investigators
- Leandro Machado Colli, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215470
- Sponsor's protocol ID
- CLARA
- Other IDs
- U1111-1267-7778, CA209-6E3
- Status last verified
- Jul 2024
- First submitted
- 17 Jan 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team is committed to sharing data generated by this project with the research community. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLARA: Characterization of Somatic and Germline Mechanisms That Impact the Immunotherapy Treatment and Prognosis of Patients With Renal Cancer
- ClinicalTrials.gov ID
- NCT05215470
- Acronym / sponsor ID
- CLARA
- Conditions
- Renal Cancer Metastatic
- Keywords
- Renal Cancer, Nivolumab, Ipilimumab, Immunotherapy, molecular profiling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital das Clínicas de Ribeirão PretoUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Jan 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 study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).
Detailed description
One hundred newly diagnosticated stage IV RCC patients will be recruited in the Ribeirao Preto Medical School.
Patients will be treated with immune checkpoint inhibitors (ICI) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment.
Patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival).
Fresh-frozen primary tumor tissue will be collected for somatic genomic characterization.
Blood DNA will be genotyped for the identification of common germline variation, as well as ancestry determination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab+Ipilimumab | Experimental | Drug: Nivolumab, Drug: IpilimumabNivolumab IV 3mg/kg 3/3w + Ipilimumab 1mg/kg 3/3w 4 doses, followed by Nivolumab IV 480mg 4/4w until progression, toxicity, or up to 2 years of use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Renal cell carcinoma patient: histological confirmed clear cell tumor;
- First-line metastatic treatment;
- Stage IV with at least one measured lesion;
- Fresh-frozen primary tumor tissue available;
- No previous immunotherapy or tyrosine kinase inhibitor treatment;
Key exclusion criteria (5 listed)
- History of a known or suspected autoimmune disease;
- Any condition requiring systemic treatment with corticosteroids;
- Creatinine clearance < 40mL/min;
- Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) > 5 x ULN;
- Pregnant women.
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 |
|---|---|---|
| NivolumabAlso: OpdivoNivolumab is called an anti-PD-1 (Programmed Cell Death Ligand 1) or a checkpoint inhibitor and is an antibody (a type of human protein) designed to allow the body's own immune system to destroy tumors | Drug | Nivolumab+Ipilimumab |
| IpilimumabAlso: YervoyIpilimumab is called an anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) and is a type of antibody that works to prevent the body's immune system from stopping to fight a specific cancer | Drug | Nivolumab+Ipilimumab |
Primary outcome
Overall Survival
Time frame: 3 years
Progression-free survival
Time frame: 2 years
1 secondary outcome
Overall Response Rate
Time frame: 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 3 Jul 2024.
- Individual participant dataSharing planned: Yes. The research team is committed to sharing data generated by this project with the research community. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.
Related trials for Renal Cancer Metastatic
RecruitingPhase 1/2
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 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, 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.
Leandro Machado Colli, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Ipilimumab in people with Renal Cancer Metastatic, run by Hospital das Clínicas de Ribeirão Preto at 1 site in Brazil.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2024. 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 Brazil. 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?
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?
Overall Survival (time frame: 3 years). The study lists 2 primary outcomes in all. 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 3 Jul 2024.