*Carcinoma, Renal Cell *Advanced Renal Cell Carcinoma *Renal Cancer *10 more
Conditions
Interventions
*Biological: PF-08634404
-Concentrate for solution for infusion
-Other Names:
#SSGJ-707
*Drug: Combination 1
-Combination Drug 1
*Drug: Combination 2
-Combination Drug 2
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator [Time Frame: Up to approximately 3 years] -ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator. *Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Through 90 days after the last study intervention (Up to approximately 3 years)] -AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention. *Number of participants with dose limiting toxicity (DLT) [Time Frame: Though end of DLT evaluation period (Up to approximately 3 years)] -The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Duration of Response (DOR) per RECIST v1.1 by investigator [Time Frame: Up to approximately 3 years] -DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. *Progression Free Survival (PFS) per RECIST v1.1 by investigator [Time Frame: Up to approximately 3 years] -Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first. *Overall Survival (OS) [Time Frame: Up to approximately 3 years] -Overall survival defined as the time from the date of randomization to the date of death due to any cause. *Number of Participants With Clinical Laboratory Abnormalities [Time Frame: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)] -laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing *Pharmacokinetics (PK): Serum concentration of PF-08634404 [Time Frame: Up to 37 days after the last dose of treatment] -Pre-dose and post dose concentrations of PF-08634404 *Incidence of Anti-Drug Antibody (ADA) against PF-08634404 [Time Frame: Up to 37 days after the last dose of treatment] -To evaluate the immunogenicity of PF-08634404 | — |
Countries
Australia, Japan, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed