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Chemotherapy
Chemoimmunotherapy for Prostate Cancer (CHAMP Trial)
Phase 2
Recruiting
Led By Andrew Armstrong, MD, ScM
Research Sponsored by Andrew J. Armstrong, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18
Karnofsky performance status of 70 or higher.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (up to 3 years)
Awards & highlights
CHAMP Trial Summary
This trial is testing the safety and efficacy of a combination of four drugs to treat men with aggressive prostate cancer. The four drugs are nivolumab, ipilimumab, cabazitaxel, and carboplatin. The trial will also investigate biomarkers to understand how the drug combination affects prostate cancer and the immune system.
Who is the study for?
This trial is for men with advanced prostate cancer that has spread and shows neuroendocrine characteristics or aggressive behavior. Participants must have a good performance status, controlled testosterone levels through ongoing therapy, acceptable lab values, and be over 18 years old. They should not have psychiatric disorders affecting trial participation, recent other cancer treatments or live vaccines, active infections like HIV or hepatitis B/C, certain autoimmune diseases, severe neuropathy, untreated brain metastases or a history of specific prior treatments.Check my eligibility
What is being tested?
The study tests the combination of nivolumab (an immunotherapy), ipilimumab (another immunotherapy), cabazitaxel (a chemotherapy drug), and carboplatin (a platinum-based chemo) in treating aggressive forms of prostate cancer. Up to 10 cycles will be given followed by maintenance doses until disease progression or unacceptable side effects occur. The study also looks at how these drugs affect the immune system and cancer biomarkers.See study design
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs; infusion reactions; fatigue; blood cell count changes leading to increased infection risk; nerve damage causing pain or numbness; allergic responses; digestive issues like nausea and diarrhea; liver function changes; skin rash and hormone level alterations.
CHAMP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I am mostly able to care for myself and carry out normal activities.
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My testosterone levels are very low or I am on hormone therapy.
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My prostate cancer is spreading despite treatment.
CHAMP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (up to 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects who are progression-free and alive (progression-free survival) at 6 months
Secondary outcome measures
Describe the best radiographic response by immune modified PCWG3-defined RECIST radiographic response.
Describe the changes in the blood-based biomarker Prostate-Specific Antigen (PSA) over time
Describe the changes in the blood-based biomarker alkaline phosphatase over time
+9 moreCHAMP Trial Design
1Treatment groups
Experimental Treatment
Group I: Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC)Experimental Treatment4 Interventions
Subjects with neuroendocrine prostate cancer (NEPC) or aggressive variant prostate cancer (AVPC) will receive a combination of nivolumab, ipilimumab, carboplatin and cabazitaxel for up to 10 cycles of 21 days each. After carboplatin and cabazitaxel are discontinued, a combination of nivolumab and ipilimumab will be administered.
Nivolumab will be administered intravenously at a dose of 360 mg every 3 weeks.
Ipilimumab will be administered intravenously at a dose of 1 mg/kg every 6 weeks.
Carboplatin will be administered intravenously at a dose of AUC 4 mg/ml per minute.
Cabazitaxel will be administered intravenously at a dose of 20 or 25 mg/m2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabazitaxel
2014
Completed Phase 3
~1290
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610
Carboplatin
2014
Completed Phase 3
~6670
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Who is running the clinical trial?
Andrew J. Armstrong, MDLead Sponsor
4 Previous Clinical Trials
109 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,789 Total Patients Enrolled
Andrew Armstrong, MD, ScMPrincipal InvestigatorDuke University
5 Previous Clinical Trials
217 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I am currently being treated for an infection.I am older than 18 years.I have had cabazitaxel or at least two chemotherapy treatments for prostate cancer.I have been treated for prostate cancer with specific hormone therapies within the last two weeks.I agree to use effective birth control and not donate sperm while on cabazitaxel treatment.I have an active tuberculosis infection.I have moderate to severe nerve damage.I have received an organ or tissue transplant from another person.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have HIV with a viral load that isn't under control and a low CD4 count.My cancer tissue samples are available for study.I am mostly able to care for myself and carry out normal activities.My prostate cancer is neuroendocrine-like, confirmed by tests or symptoms.I had another type of cancer but have been cancer-free for 2 years after treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My testosterone levels are very low or I am on hormone therapy.I have stable brain metastases and haven't needed high doses of steroids recently.I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation from it.You currently have active Hepatitis B or Hepatitis C infection.I have an immune system disorder or have been on high-dose steroids or other drugs that weaken my immune system recently.I have had or currently have lung inflammation treated with steroids.My prostate cancer is spreading despite treatment.I have been treated with specific immune therapy drugs before.
Research Study Groups:
This trial has the following groups:- Group 1: Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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