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Clinical Trial 21691

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT05239728

Phase: Phase III
Principal Investigator: Chahoud, Jad

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Multi-center, Double-Blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) plus Pembrolizumab (MK- 3475) Versus Placebo plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (6482-022)

Summary

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.

Objective

Primary Objective: To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Secondary Objectives: To compare overall survival (OS) for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. To compare the safety and tolerability profiles for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. To compare measures of disease recurrence-specific survival (DRSS) as assessed by the investigator, in participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. To evaluate change from baseline in health-related quality of life (HRQoL) and symptoms using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life 30 Questionnaire (QLQ-C30) and the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-related Symptoms (FKSI-DRS).

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

Belzutifan (); Belzutifan/Placebo (); Pembrolizumab (Keytruda)

Inclusion Criteria

Inclusion Criteria:

Has a histologically or cytologically confirmed diagnosis of 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: Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0 High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0 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 occurs last

Has adequate organ function

Exclusion Criteria

Exclusion Criteria:

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 pulse oximeter reading > 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

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

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