AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 800
- 试验地点
- 321
- 主要终点
- Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
研究概览
简要总结
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.
To join the study, participants must meet the following conditions:
- Be 18 years or older.
- Have colorectal cancer that has spread to other parts of your body.
- Be in good enough health to receive study treatment.
- Should not be pregnant before starting treatment.
Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.
The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.
- The study is expected to last approximately 33 months for each participant.
- Participants will have regular visits to the study site for treatment, health checks, and tests.
- After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.
- Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Histological or cytological confirmed colorectal adenocarcinoma.
- •Evidence of Stage IV metastatic disease.
- •No prior systemic therapy for metastatic disease.
- •Eastern Cooperative Oncology Group performance status (ECOG) 0-1
- •At least one measurable lesion according to RECIST 1.1 per Investigator assessment.
- •Adequate hepatic, liver, and renal function
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Locally confirmed BRAF V600E mutation
- •Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
- •Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- •Clinically significant risk of hemorrhage or fistula
- •Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- •Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
- •Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
- •Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
- •Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
研究组 & 干预措施
Bevacizumab + Chemotherapy
Participants will receive bevacizumab IV in combination with Chemotherapy.
干预措施: Bevacizumab (Biological)
PF-08634404 + Chemotherapy
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
干预措施: PF-08634404 (Drug)
Bevacizumab + Chemotherapy
Participants will receive bevacizumab IV in combination with Chemotherapy.
干预措施: Chemotherapy (Drug)
PF-08634404 + Chemotherapy
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
时间窗: Approximately 4 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 BICR per RECIST 1.1, or death due to any cause, whichever occurs first.
Overall survival (OS)
时间窗: Approximately 4 years
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
次要结局
- Pharmacokinetics (PK): Serum concentration of PF-08634404(Approximately 21 months)
- Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29(Approximately 4 years)
- Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29(Approximately 4 years)
- Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA)(Approximately 21 months)
- PFS per RECIST 1.1 by investigator assessment(Approximately 4 years)
- Objective Response Rate (ORR) by BICR(Approximately 4 years)
- Objective Response Rate (ORR) by investigator(Approximately 4 years)
- Duration of Response (DOR) by BICR(Approximately 4 years)
- DOR by investigator(Approximately 4 years)
- PFS2 (PFS after next-line therapy) by investigator(Approximately 4 years)
- Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Through 90 days after the last study intervention; Approximately 4 years)
- Number of Participants With Clinical Laboratory Abnormalities(Through 90 days after the last study intervention; Approximately 4 years)
- Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30(Approximately 4 years)
- PFS per RECIST 1.1 by investigator assessment(Approximately 4 years)
- Objective Response Rate (ORR) by BICR(Approximately 4 years)
- Objective Response Rate (ORR) by investigator(Approximately 4 years)
- Duration of Response (DOR) by BICR(Approximately 4 years)
- DOR by investigator(Approximately 4 years)
- PFS2 (PFS after next-line therapy) by investigator(Approximately 4 years)
- Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Through 90 days after the last study intervention; Approximately 4 years)
- Number of Participants With Clinical Laboratory Abnormalities(Through 90 days after the last study intervention; Approximately 4 years)
- Pharmacokinetics (PK): Serum concentration of PF-08634404(Approximately 21 months)
- Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA)(Approximately 21 months)
- Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Approximately 4 years)
- Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29(Approximately 4 years)
- Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30(Approximately 4 years)
- Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29(Approximately 4 years)