An Open-label, Randomized Phase 3 Study of Immune and Targeted Combination Therapies, as First-line Treatment in Participants with Advanced ccRCC

JRCT ID: jRCT2031210435

Registered date:19/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Renal cell carcinoma
• Date of first enrollment: 20/12/2021
• Target sample size: 91
• Countries of recruitment: USA,Japan,Canada,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Guatemala,Japan,Denmark,Japan,Finland,Japan,Italy,Japan,Norway,Japan,Spain,Japan,Sweden,Japan,Poland,Japan,Russia,Japan,Croatia,Japan,Serbia,Japan,South Africa,Japan,Turkey,Japan,Ukraine,Japan,Czech Republic,Japan,Hungary,Japan,Romania,Japan,France,Japan,Germany,Japan,United Kingdom,Japan,Ireland,Japan,Australia,Japan,South Koreia,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

- pembrolizumab 400 mg administered IV Q6W plus belzutifan 120 mg administered orally QD plus lenvatinib 20 mg administered orally QD
- Pembrolizumab/quavonlimab (co-formulation of pembrolizumab 400 mg and quavonlimab 25 mg) administered IV Q6W plus lenvatinib 20 mg administered orally QD
- Pembrolizumab 400 mg administered IV Q6W plus lenvatinib 20 mg administered orally QD

Outcome(s)

Primary Outcome

- Progression Free Survival (PFS)
- Overall Survival (OS)

Secondary Outcome

- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Has histologically confirmed diagnosis of RCC with clear cell component
- Has received no prior systemic therapy for advanced ccRCC
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib
- Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
- Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation

Exclude criteria

- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
- Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
- Has clinically significant cardiac disease within 12 months from first dose of study intervention
- Has a history of interstitial lung disease
- Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible
- Has preexisting gastrointestinal or non-gastrointestinal fistula
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B
- Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
- Has clinically significant history of bleeding within 3 months prior to randomization
- Has had an allogenic tissue/solid organ transplant

Related Information

• Primary Sponsor: Tomohiro Ubakai
• Secondary ID(s): NCT04736706