AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 224
- 试验地点
- 128
- 主要终点
- Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator
研究概览
简要总结
This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.
To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.
Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories
排除标准
- •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 or acute gastrointestinal bleeding within 6 months prior to the first dose
- •Acute, chronic or symptomatic infections
- •Participants with history of immunodeficiency
研究组 & 干预措施
Cohort A
Participants will receive PF-08634404 IV.
干预措施: PF-08634404 (Drug)
Cohort C
Participants will receive PF-08634404 IV in combination with axitinib.
干预措施: PF-08634404 (Drug)
Cohort B
Participants will receive PF-08634404 in combination with ipilimumab.
干预措施: PF-08634404 (Drug)
Cohort B
Participants will receive PF-08634404 in combination with ipilimumab.
干预措施: Ipilimumab (Drug)
Cohort C
Participants will receive PF-08634404 IV in combination with axitinib.
干预措施: Axitinib (Drug)
结局指标
主要结局
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator
时间窗: 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)
时间窗: 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)
时间窗: 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).
次要结局
- Duration of Response (DOR) per RECIST v1.1 by investigator(Up to approximately 3 years)
- Progression Free Survival (PFS) per RECIST v1.1 by investigator(Up to approximately 3 years)
- Overall Survival (OS)(Up to approximately 3 years)
- Number of Participants With Clinical Laboratory Abnormalities(Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years))
- Pharmacokinetics (PK): Serum concentration of PF-08634404(Up to 37 days after the last dose of treatment)
- Incidence of Anti-Drug Antibody (ADA) against PF-08634404(Up to 37 days after the last dose of treatment)