A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)

NCT06284564 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0538NCI-2024-03604
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year

Study Arms (1)

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.

Drug: Evolocumab; Drug: Nivolumab

Interventions

Evolocumab DRUG

Given by SC

Evolocumab + Nivolumab

Nivolumab DRUG

Given by IV

Also known as: BMS-936558, Opdivo

Evolocumab + Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• i. 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)
• iv. 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.
• i. 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bristol-Myers Squibb: collaborator
• Cancer Prevention Research Institute of Texas: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

evolocumab; Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Eric Jonasch, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 29, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (2)