Condition: Carcinoma, Renal Cell, Advanced Renal Cell Carcinoma, Renal Cancer, Renal Neoplasm, Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma, Carcinoma, Renal Cell Metastasis, Advanced or Metastatic Renal Cell Carcinoma, Carcinoma, Renal Cell, Advanced, Metastatic Renal Cell Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic/Advanced Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07227415

Sponsor: Pfizer

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• 18 years of age or older at screening
• Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
• At least one measurable (as defined by the investigator) and untreated lesion
• Adequate hematologic, hepatic, cardiac and renal function
• No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received >12 months prior)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories.

Exclusion Criteria:

• Participants may be excluded if they meet any of the following:
• Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
• Clinically significant risk of haemorrhage or fistula
• History of another malignancy within 3 years
• History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• active autoimmune diseases requiring systemic treatment within the past 2 years
• uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
• Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study
• History of severe bleeding tendency or coagulation dysfunction
• History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess
• Acute, chronic or symptomatic infections
• Participants with history of immunodeficiency

View trial on ClinicalTrials.gov