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Compares treatment options for Clear Cell Renal Cell Carcinoma
Official title Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)
ClinicalTrials.gov ID: NCT07187778
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as Keytruda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Biopsy proven clear cell renal cell carcinoma (ccRCC). a. Extra tissue should be submitted if available for correlative analysis. Formalin-fixed...
- Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading...
- pT2 (by radiographic/size criteria), Grade 4 or with sarcomatoid/rhabdoid features (on biopsy), N0, M0
- pT3 (presence of tumor thrombus, perinephric and/or sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC\
- pT4, any g.rade, N0, M0
You likely can't join if
- Has any of the following:
- A pulse oximeter reading \<92% at rest, or
- Requires intermittent supplemental oxygen, or
- Requires chronic supplemental oxygen
- Patients who have had chemotherapy or radiotherapy for RCC prior to study.
- Patients who are receiving any other investigational agents.
See the full eligibility criteria
Who can join
- Biopsy proven clear cell renal cell carcinoma (ccRCC). a. Extra tissue should be submitted if available for correlative analysis. Formalin-fixed paraffinembedded (FFPE) tissue blocks are preferred to slides. Details...
- Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading: Intermediate-high risk ccRCC\
- pT2 (by radiographic/size criteria), Grade 4 or with sarcomatoid/rhabdoid features (on biopsy), N0, M0
- pT3 (presence of tumor thrombus, perinephric and/or sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC\
- pT4, any g.rade, N0, M0
- pT, any stage, any grade, N+, M0 M1 RCC participants who present with the primary kidney tumor, but also solid, isolated, soft tissue metastases that are planned to be completely resected at the time of nephrectomy are...
- NOTE: Fuhrman Tumor Grade and/or WHO/ISUP Tumor Grade are required for all people entering the study.
- Evaluated by urology and approved as candidates for nephrectomy.
- Age ≥18 years and consent to participation.
- Performance status of 0-1 per Zubrod/Eastern Cooperative Oncology Group [ECOG] scale.
- Absence of distant metastases on imaging of chest, abdomen and pelvis within 42 days of enrollment (by CT, MRI, or PET imaging). Brain imaging is not required unless clinical suspicion per the treating provider.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Screening laboratory criteria include the following: a. ANC ≥1000, PLT ≥ 75, Hgb ≥9 (transfusion allowed if Hgb \< 1.5 or = to upper limit of normal
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (see below) prior to study entry and for the duration of study participation, including for 120 days after the last dose of...
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user...
- This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: o...
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
- Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: \- Agree to use a male condom plus partner use of an additional contraceptive method...
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of pembrolizumab and 30 days after last...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Has any of the following:
- A pulse oximeter reading \<92% at rest, or
- Requires intermittent supplemental oxygen, or
- Requires chronic supplemental oxygen
- Patients who have had chemotherapy or radiotherapy for RCC prior to study.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to belzutifan, pembrolizumab, or other agents used in study.
- Prior systemic therapy with anti-PD1, PD-L1, PD-L2, or CTLA-4 or received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) ≤28 days prior to the first dose of study intervention.
- Diagnosis of immunodeficiency, active autoimmune disease (per Investigator's discretion), history of pneumonitis, active infection, or known additional malignancy other than RCC.
- Has a known history of HIV infection. Note: Testing for HIV at screening is only required if mandated by local health authority.
- Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA [qualitative] is detected) infection. Note: Testing for HBV and HCV is only required if mandated by local health authority.
- Patients who cannot fulfill study requirements for any reason.
- Pregnant or breastfeeding women are excluded from this study because pembrolizumab is a Class-D agent with the potential for teratogenic or abortifacient effects and belzutifan has shown embryofetal toxicity in...
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. a. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or...
- Has any known metastatic disease that is not planned to undergo surgical resection at the time of surgery (with the exception of ipsilateral adrenal metastases that are resectable at surgery).
- Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction ≤6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart...
- Has moderate to severe hepatic impairment (Child-Pugh B or C).
- Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption).
- Has received prior treatment with belzutifan or another HIF-2α inhibitor.
- Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers...
- Has active TB.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.