Phase II Trial of Combination Immunotherapy in Biochemically Recurrent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Toxicity
研究概览
简要总结
Background:
Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor people and their PSA values over time. Researchers want to see if a combination of new drugs can help these people.
Objective:
To see if the combination treatment of PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec vaccinia), CV301, and MSB0011359C (M7824) can induce an anti-tumor impact in people with biochemically recurrent prostate cancer.
Eligibility:
People ages 18 and older with certain kinds of prostate cancer
Design:
Participants will be screened with
- Medical history
- Physical exam
- Blood and urine tests
- A scan of the neck, chest, abdomen, and pelvis
- A bone scan
A sample of tissue that was already taken will be tested. This will confirm the diagnosis, stage, and disease status.
Some participants will have close monitoring with four monthly PSA checks.
All participants will get two study drugs as shots under the skin. They will get the third drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be checked before they get the drugs and for up to 1 hour after.
Participants will have frequent study visits. They will have physical exams, urine and blood tests, and scans.
Participants will return to the clinic about 4 weeks after they stop taking the study drugs. They will have a medical history, physical exam, and blood tests. They may also have long-term follow-up visits.
详细描述
Background:
Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy (i.e., biochemically recurrent [BCR] prostate cancer). The primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on conventional imaging.
ADT can lower the prostate-specific antigen (PSA) in these patients, but because of its substantial side effect profile and ambiguous long-term impact, it is generally deferred by most patients until there is a rapid escalation in their PSA.
Immunotherapy presents an alternative option for these patients that is especially attractive because it is not associated with substantial toxicity. Also, since immunotherapy can have lasting effects after treatment due to a sustained activated immune response, patients will not be required to take these treatments indefinitely to potentially benefit clinically.
Current and previous clinical trials have demonstrated that single agent immunotherapy can impact PSA in patients in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1/Safety Lead-in Combination Therapy (closed December 2018)
Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301+ MSB0011359C (M7824)
干预措施: MSB0011359C (M7824) (Drug)
1/Safety Lead-in Combination Therapy (closed December 2018)
Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301+ MSB0011359C (M7824)
干预措施: CT scan of chest (Diagnostic Test)
1/Safety Lead-in Combination Therapy (closed December 2018)
Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301+ MSB0011359C (M7824)
干预措施: CT scan of abdomen/pelvis (Diagnostic Test)
1/Safety Lead-in Combination Therapy (closed December 2018)
Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301+ MSB0011359C (M7824)
干预措施: MRI (Diagnostic Test)
1/Safety Lead-in Combination Therapy (closed December 2018)
Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301+ MSB0011359C (M7824)
干预措施: Bone scan (Diagnostic Test)
2/Biochemical Recurrence: Combination Therapy + Surveillance (closed)
Surveillance followed by Prostvac ( rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301 then Prostvac + CV301 + MSB0011359C (M7824)
干预措施: MSB0011359C (M7824) (Drug)
2/Biochemical Recurrence: Combination Therapy + Surveillance (closed)
Surveillance followed by Prostvac ( rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301 then Prostvac + CV301 + MSB0011359C (M7824)
干预措施: CT scan of chest (Diagnostic Test)
2/Biochemical Recurrence: Combination Therapy + Surveillance (closed)
Surveillance followed by Prostvac ( rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301 then Prostvac + CV301 + MSB0011359C (M7824)
干预措施: CT scan of abdomen/pelvis (Diagnostic Test)
2/Biochemical Recurrence: Combination Therapy + Surveillance (closed)
Surveillance followed by Prostvac ( rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301 then Prostvac + CV301 + MSB0011359C (M7824)
干预措施: MRI (Diagnostic Test)
2/Biochemical Recurrence: Combination Therapy + Surveillance (closed)
Surveillance followed by Prostvac ( rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301 then Prostvac + CV301 + MSB0011359C (M7824)
干预措施: PSMA (Diagnostic Test)
2/Biochemical Recurrence: Combination Therapy + Surveillance (closed)
Surveillance followed by Prostvac ( rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301 then Prostvac + CV301 + MSB0011359C (M7824)
干预措施: Bone scan (Diagnostic Test)
3/Biochemical Recurrence: Combination Antigen Direct Immunotherapy +/- Surveillance
Surveillance as needed followed by Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301
干预措施: CT scan of chest (Diagnostic Test)
3/Biochemical Recurrence: Combination Antigen Direct Immunotherapy +/- Surveillance
Surveillance as needed followed by Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301
干预措施: CT scan of abdomen/pelvis (Diagnostic Test)
3/Biochemical Recurrence: Combination Antigen Direct Immunotherapy +/- Surveillance
Surveillance as needed followed by Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301
干预措施: MRI (Diagnostic Test)
3/Biochemical Recurrence: Combination Antigen Direct Immunotherapy +/- Surveillance
Surveillance as needed followed by Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301
干预措施: PSMA (Diagnostic Test)
3/Biochemical Recurrence: Combination Antigen Direct Immunotherapy +/- Surveillance
Surveillance as needed followed by Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301
干预措施: Bone scan (Diagnostic Test)
结局指标
主要结局
Percentage of Participants With a Toxicity
时间窗: At the end of therapy (7 months)
Percentage of participants with a toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Prostate Specific Antigen (PSA) Response
时间窗: End of treatment (7 months)
Proportion of evaluable participants who experience at least a 30% decline. PSA is a tumor marker in prostate cancer and elevated in participants with this stage of disease. Declines of 30% can be associated with favorable clinical outcomes.
次要结局
- Number of Participants With Related and/or Unrelated Grade 3 and Grade 4 Adverse Events.(6 weeks)
- Number of Evaluable Participants With Biochemical Recurrence (BCR) With a 20% Change in PSA Doubling Time(End of treatment after 7 months)
研究者
Ravi A. Madan, M.D.
Principal Investigator
National Cancer Institute (NCI)