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Phase 3 study of belzutifan plus pembrolizumab as adjuvant treatment in renal cell carcinoma (RCC)
EU CTIS ID: 2023-505023-31-00
What this study is testing
To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
- Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: (1) Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0 (2) High risk RCC: pT4, any grade N0, M0; pT any stage, any Grade N+, M0 (3) M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
- Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
- Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization
- Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
You likely can't join if
- Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
- Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection, requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B or known active Hepatitis C virus infection
See the full eligibility criteria
Who can join
- Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
- Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: (1) Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0 (2) High risk RCC: pT4, any grade N0, M0; pT any stage, any Grade N+, M0 (3) M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
- Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
- Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization
- Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
- Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occur last
- Has adequate organ function
What rules you out
- Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
- Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection, requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B or known active Hepatitis C virus infection
- Has had an allogenic tissue/solid organ transplant
- Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
- Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
- Has preexisting brain or bone metastatic lesions
- Has received prior systemic therapy for RCC
- Has received prior radiotherapy for RCC
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- New Zealand
- Canada
- Turkey
- Brazil
- Colombia
- Taiwan
- Singapore
- Chile
- China
- Thailand
- Japan
- Australia
- Israel
- Korea, Republic of
- Malaysia
- United States
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; New Zealand; Canada; Turkey; Brazil; Colombia and 12 more location(s). 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 EU CTIS; the study team decides eligibility.