Metastatic Renal Cell CarcinomaPhase 2NCT06284564
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)
A Phase 2 study testing Evolocumab and Nivolumab in people with Metastatic Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Evolocumab and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2024to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed renal cell carcinoma (RCC), with clear-cell component, with or without sarcomatoid features
- Prior treatment with VEGF and/or immunotherapy agent(s), including VEGF-IO combinations or IO-IO combinations, are required in the metastatic setting. If participants have not received prior VEGF and IO agents (in combination or in sequence), then documentation of participant refusal of standard of care treatment.
- Age ≥18 years
- Participants or their legally acceptable representative must have signed and dated an Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 OR Karnofsky Performance Status (KPS) ≥ 70%
- Participants must have adequate organ and marrow function as defined below:
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- absolute neutrophil count ≥ 1,500/mcL ii. platelets ≥ 100,000/mcL iii. hemoglobin (Hgb) ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
- total bilirubin ≤ institutional upper limit of normal (ULN) OR bilirubin < 3.0 ml/dL and direct bilirubin ≤ ULN for subjects with Gilbert's syndrome with total bilirubin levels > 1.5 ULN v. AST(SGOT)/ALT(SGPT)* ≤ 2.5 × institutional ULN OR ≤ 5 ULN for patients with documented liver metastases vi. serum creatinine ≤ 1.5 × institutional ULN OR eGFR ≥ 40 mL/min for subject with creatinine levels > 1.5 × institutional ULN
- Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)-AST(SCOT)/ Alanine aminotransferase (serum glutamic-pyruvic transaminase)- ALT(SGPT)
- Effective contraception for women of child-bearing potential (WOCBP) participants as defined by World Health Organization (WHO) guidelines for 1 "highly effective" method or 2 "effective" methods.
- WOCBP require a negative pregnancy test to initiate treatment ii. Willingness to continue contraception for at least 5 months after the last nivolumab dose.
- Effective contraception for men of child-bearing potential (MOCBP) participants as defined by WHO guidelines for 1 "highly effective" method or 2 "effective" methods. Sperm or egg donation/banking is not allowed during the participation of the study.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Who cannot join
- Chemotherapy, immunotherapy, or other experimental cancer therapy within 2 weeks prior to starting study treatment
- Must have recovered from all anticancer treatment-related toxicities to Grade 1 or less, except for alopecia and endocrinopathies that are stable on treatment with replacement therapy (immune therapy-related endocrinopathies treated with prednisone 10 mg per day [or equivalent] are acceptable).
- Participants receiving any concomitant systemic therapy for RCC are excluded. Patients must not be scheduled to receive another experimental drug while on this study.
- Symptomatic brain or leptomeningeal metastases, including participants who continue to require glucocorticoids and/or antiseizure therapy. Treated, asymptomatic brain are leptomeningeal metastases are permitted, provided patient has completed radiation at least 2 weeks prior to day 1 and on a physiologic dose of steroids (prednisone equivalent 10mg daily) for at least 1 week prior to day 1 of study treatments. Stable, untreated brain metastases (based on CNS imaging > 4 weeks apart) permitted if participants does not require steroids or antiseizure therapy.
- Has known hypersensitivity to any of the study drugs or excipients, including history of severe allergic, anaphylactic, or other hypersensitivity reactions to fusion proteins, or known hypersensitivity or allergy to Chinese hamster ovary cell products.
- Active infection requiring systemic therapy within 14 days prior to treatment assignment
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- Symptomatic congestive heart failure of New York heart Association Class III or IV i. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease ii. Severely impaired lung function as defined as 02 saturation that is 88% or less at rest on room air • uncontrolled hypertension (SBP ≥ 160 mm Hg or DBP ≥ 90 mm Hg) despite treatment with antihypertensives
- Has evidence of any other medical conditions, psychiatric condition, physical examination or laboratory findings that may interfere with the planned treatment, affect subject compliance or place the subject at high risk from treatment-related complications in the opinion of the Investigator.
- Pregnant women are excluded from this study. Women who are breastfeeding should discontinue prior to initiating treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied.
Read the detailed description
Primary Objectives:
- To determine the objective response rate (Partial Response (PR) and Complete Response (CR)) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria of evolocumab and nivolumab in patients with metastatic renal cell carcinoma (mRCC) refractory to immunotherapy and/or Vascular endothelial growth factor (VEGF) blockade
To confirm safety of evolocumab and nivolumab in participants with metastatic renal cell carcinoma (mRCC) refractory to immunotherapy and/or Vascular endothelial growth factor (VEGF) blockade Detail the primary protocol objectives.
Secondary Objectives:
- To describe the adverse events associated with evolocumab and administered with nivolumab
- To determine the disease control rate (Stable Disease (SD)/PR/CR) based on RECIST 1.1 and iRECIST criteria
- To determine duration of response in patients who achieve response
- To determine progression free survival based on RECIST 1.1 criteria and iRECIST criteria
- To determine 1-year survival rates and overall survival
Exploratory Objectives:
- To evaluate CD3 and CD8 T-cell infiltration and MHC-1 expression of paired tumor biopsies before and after treatment
- To evaluate plasma low-density lipoproteins (LDL) cholesterol levels and circulating Proprotein convertase subtilisin/kexin type 9 (PSCK9) levels at baseline and on treatment
- To evaluate circulating lymphoid and myeloid cell subsets and changes on treatment
- To evaluate circulating tumor cells and changes on treatment
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Evolocumab, Nivolumab
- 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.
EvolocumabDrug
Given by SC
NivolumabDrug
Also called BMS-936558, Opdivo
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab + Nivolumab | Experimental | If you are found to be eligible to take part in this study, you will receive evolocumab and nivolumab on Day 1 of each cycle (every 4 weeks). Evolocumab will be given as an injection under the skin. Nivolumab will be given by vein over about 60 minutes. Receives: Drug: Evolocumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start7 Aug 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Cancer Prevention Research Institute of Texas, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Eric Jonasch, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284564
- Sponsor's protocol ID
- 2023-0538
- Other IDs
- NCI-2024-03604
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)
- ClinicalTrials.gov ID
- NCT06284564
- Acronym / sponsor ID
- 2023-0538
- Conditions
- Metastatic Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Cancer Prevention Research Institute of Texas, United States Department of Defense
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 29 Feb 2024 (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.
To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied.
Detailed description
Primary Objectives:
- To determine the objective response rate (Partial Response (PR) and Complete Response (CR)) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria of evolocumab and nivolumab in patients with metastatic renal cell carcinoma (mRCC) refractory to immunotherapy and/or Vascular endothelial growth factor (VEGF) blockade
To confirm safety of evolocumab and nivolumab in participants with metastatic renal cell carcinoma (mRCC) refractory to immunotherapy and/or Vascular endothelial growth factor (VEGF) blockade Detail the primary protocol objectives.
Secondary Objectives:
- To describe the adverse events associated with evolocumab and administered with nivolumab
- To determine the disease control rate (Stable Disease (SD)/PR/CR) based on RECIST 1.1 and iRECIST criteria
- To determine duration of response in patients who achieve response
- To determine progression free survival based on RECIST 1.1 criteria and iRECIST criteria
- To determine 1-year survival rates and overall survival
Exploratory Objectives:
- To evaluate CD3 and CD8 T-cell infiltration and MHC-1 expression of paired tumor biopsies before and after treatment
- To evaluate plasma low-density lipoproteins (LDL) cholesterol levels and circulating Proprotein convertase subtilisin/kexin type 9 (PSCK9) levels at baseline and on treatment
- To evaluate circulating lymphoid and myeloid cell subsets and changes on treatment
- To evaluate circulating tumor cells and changes on treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evolocumab + Nivolumab | Experimental | Drug: Evolocumab, Drug: NivolumabIf you are found to be eligible to take part in this study, you will receive evolocumab and nivolumab on Day 1 of each cycle (every 4 weeks). Evolocumab will be given as an injection under the skin. Nivolumab will be given by vein over about 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed renal cell carcinoma (RCC), with clear-cell component, with or without sarcomatoid features
- Prior treatment with VEGF and/or immunotherapy agent(s), including VEGF-IO combinations or IO-IO combinations, are required in the metastatic setting. If participants have not received prior VEGF and IO agents (in combination or in sequence), then documentation of participant refusal of standard of care treatment.
- Age ≥18 years
- Participants or their legally acceptable representative must have signed and dated an Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 OR Karnofsky Performance Status (KPS) ≥ 70%
Key exclusion criteria (9 listed)
- Chemotherapy, immunotherapy, or other experimental cancer therapy within 2 weeks prior to starting study treatment
- Must have recovered from all anticancer treatment-related toxicities to Grade 1 or less, except for alopecia and endocrinopathies that are stable on treatment with replacement therapy (immune therapy-related endocrinopathies treated with prednisone 10 mg per day [or equivalent] are acceptable).
- Participants receiving any concomitant systemic therapy for RCC are excluded. Patients must not be scheduled to receive another experimental drug while on this study.
- Symptomatic brain or leptomeningeal metastases, including participants who continue to require glucocorticoids and/or antiseizure therapy. Treated, asymptomatic brain are leptomeningeal metastases are permitted, provided patient has completed radiation at least 2 weeks prior to day 1 and on a physiologic dose of steroids (prednisone equivalent 10mg daily) for at least 1 week prior to day 1 of study treatments. Stable, untreated brain metastases (based on CNS imaging > 4 weeks apart) permitted if participants does not require steroids or antiseizure therapy.
- Has known hypersensitivity to any of the study drugs or excipients, including history of severe allergic, anaphylactic, or other hypersensitivity reactions to fusion proteins, or known hypersensitivity or allergy to Chinese hamster ovary cell products.
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 |
|---|---|---|
| EvolocumabGiven by SC | Drug | Evolocumab + Nivolumab |
| NivolumabAlso: BMS-936558, OpdivoGiven by IV | Drug | Evolocumab + Nivolumab |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 15 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Eric Jonasch, MD principal investigator
M.D. Anderson Cancer Center
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 Evolocumab and Nivolumab in people with Metastatic Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.
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 9 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 15 Oct 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 United States. 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?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). 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 15 Oct 2026.