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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
Neuroendocrine-like prostate cancer, based on histology OR based on clinical presentation as defined by meeting one of the two below criteria. All subjects must submit their primary tumor or metastatic biopsy pathology specimens to the Duke Cancer Institute where they will be centrally reviewed by Duke Pathology. Central Duke pathologic review is not required for screening but rather for confirmation of histologic subtype. Local pathologic review is sufficient for eligibility determination.
Age >18
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 below
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My prostate cancer is neuroendocrine-like, confirmed by tests or symptoms.
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I am older than 18 years.
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I agree to use effective birth control and not donate sperm while on cabazitaxel treatment.
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I am mostly able to care for myself and carry out normal activities.
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My cancer tissue samples are available for study.
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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 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (up to 3 years) for reporting.

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 more

CHAMP 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
~2670
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Andrew J. Armstrong, MDLead Sponsor
4 Previous Clinical Trials
109 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,631 Previous Clinical Trials
4,126,625 Total Patients Enrolled
Andrew Armstrong, MD, ScMPrincipal InvestigatorDuke University
5 Previous Clinical Trials
217 Total Patients Enrolled

Media Library

Cabazitaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04709276 — Phase 2
Prostate Carcinoma Research Study Groups: Neuroendocrine Prostate Cancer (NEPC) or Aggressive Variant Prostate Cancer (AVPC)
Prostate Carcinoma Clinical Trial 2023: Cabazitaxel Highlights & Side Effects. Trial Name: NCT04709276 — Phase 2
Cabazitaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04709276 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What precautionary measures should be taken when using Nivolumab?

"The safety of Nivolumab was evaluated by Power and given a score of 2 due to the fact that it is in Phase 2 trials, meaning there has been some research regarding its security but nothing yet verifying its efficacy."

Answered by AI

What are the primary applications of Nivolumab?

"Nivolumab is primarily used to combat malignant neoplasms, but can also help patients with dangerous and recurrent cases of unresectable melanoma and squamous cell carcinoma."

Answered by AI

How often has Nivolumab been utilized in clinical research?

"Currently, there are 1,430 clinical trials assessing the effects of Nivolumab with 298 in their final stage. While some tests occur specifically within Shanghai, an array of 83,733 sites are investigating this drug."

Answered by AI

How many applicants are being admitted to this medical trial?

"Verified. The clinical trial is currently enrolling patients and the information present on clinicialtrials.gov attests to this; it was initially added on June 7th 2021, and edited most recently on June 2nd 2022. There are 43 positions available across 1 site for prospective participants."

Answered by AI

Are there any vacancies for individuals to partake in this clinical trial?

"Per the details on clinicaltrials.gov, enrolment for this medical trial is currently happening. It was released to the public on June 7th 2021 and updated as recently as June 2nd 2022."

Answered by AI
~8 spots leftby Dec 2024