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Trial NCT07227415

Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

Phase
Phase 1/2
Sponsor
Pfizer
Conditions
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
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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.Performance status * 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.Brain metastases * Clinically significant risk of haemorrhage or fistula * History of another malignancy within 3 yearsPrior malignancy * 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 or acute gastrointestinal bleeding within 6 months prior to the first dose * Acute, chronic or symptomatic infections * Participants with history of immunodeficiency

Restrictions found (3)

Recruiting in Massachusetts

  • Brigham and Women's Hospital · Boston, Suffolk County
  • Dana-Farber Cancer Institute · Boston, Suffolk County
  • Dana-Farber Cancer Institute - Chestnut Hill · Newton, Middlesex County