A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (U03): Substudy 03A

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Renal Cell Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Has a histologically confirmed diagnosis of locally advanced/metastatic clear cell component renal cell carcinoma (ccRCC) (with or without sarcomatoid features), ie, Stage IV RCC per AJCC. 2. Has received no prior systemic therapy for advanced RCC. [1L participants] Note: Prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed =12 months prior to randomization. 3. Submits an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.

You may not be eligible for this study if the following are true:

  • 1. Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 12 months from Day 1 of study intervention administration, or New York Heart Association Class III or IV congestive heart failure, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. 2. Prolongation of QTcF interval to >480 ms. 3. Has a LVEF below the institutional (or local laboratory) normal range as determined by MUGA or ECHO. 4. Has had major surgery within 3 weeks prior to first dose of study interventions.


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