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
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)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - Prior malignancyConditionalexclusion
within 3 years
Show in the text
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