Chemotherapy, Immunotherapy and PARP Inhibitor for the Treatment of Metastatic Aggressive Variant Prostate Cancer (AVPC)
Clinicaltrials.gov identifier:
NCT04592237
Treatment
Treatment in people with aggressive metastatic prostate cancer
Study Contact Information:
For additional information, please contact:
Ana Aparicio by phone: 713-563-6969 or by email: [email protected]
Chemotherapy, Immunotherapy and PARP Inhibitor for the Treatment of Metastatic Aggressive Variant Prostate Cancer
About the Study
This study will look at how well the combination of chemotherapy drugs (such as cabazitaxel and carboplatin), a PARP inhibitors (), and an agents (cetrelimab) works for treating people with a rare type of cancer known as aggressive variant cancer (AVPC). The research will compare the benefits of giving with or without cetrelimab, after treatment with chemotherapy.
Type of Study
This is a two-arm, , study.
- Participants will be placed into one of two study groups by chance, neither the participants nor the researchers choose the group into which the participants are placed. Participants will be told which group they have been assigned to.
- Participants will have treatment in two phases during this study. During Phase 1, the induction phase, participants will all receive the same treatment with chemotherapy and . Phase 2, the maintenance phase will begin after participants have completed chemotherapy and . During Phase 2, participants in each group will receive different treatment.
- Group 1 will receive treatment with a .
- Group 2 will receive treatment with a combined with an .
What the Study Involves
Induction phase
- Patients in both groups will receive the chemotherapy agents cabazitaxel intravenously (IV) and carboplatin IV on day 1.
- Beginning in cycle 2, all patients will also receive the cetrelimab IV on day 1.
- Treatment repeats for up to 6 cycles in the absence of disease progression or unacceptable .
Maintenance phase
- Group 1
- Participants will take orally each day on days 1-28.
- Cycles repeat every 28 days in the absence of disease progression or unacceptable .
- Group 2
- Participants will receive cetrelimab IV on day 1.
- Participants will take orally each day on days 1-28.
- Cycles repeat every 28 days in the absence of disease progression or unacceptable .
Study participants will be followed up to 5 years.
Study Site
- Houston, Texas
MD Anderson Cancer Center
Contact: Ana Aparicio by phone: 713-563-6969 or by email: [email protected]
Lead Researcher: Ana Aparicio
Men age 18 years or older who meet the following criteria:
- Has prostate cancer, with evidence of disease progression
- Meets at least one of the following criteria of AVPC:
- Small cell (neuroendocrine) cancer.
- Exclusive visceral metastases.
- Mostly lytic bone metastases identified by plain x-ray or
- Bulky lymph node enlargement or high-grade tumor mass in prostate/pelvis.
- Low (10 ng/mL or less) at initial diagnosis and high volume (20 or more) bone metastases.
- Developed castration resistance a short time after beginning hormonal therapy.
- Tumor mutation or loss of function in at least two of the following three genes: , RB1 and .
- Must provide tissue samples at specified timepoints during the study.
- Surgical or chemical castration, with baseline testosterone levels of 50 ng/dL or less.
Check clinicaltrials.gov for additional eligibility.
- Had prior treatment for with carboplatin, cisplatin, cabazitaxel, PARP-inhibitor or an anti-PD1 or anti-PDL1 inhibitor
- Received more than one treatment of chemotherapy
- Not recovered from adverse events, major surgery, or radiation for the treatment of cancer
- An additional malignancy (other than the one treated in this study) which has a >= 30% probability of recurrence within 24 months
- Active or prior documented autoimmune or inflammatory disorders (Contact the Study Team for a list of exceptions)