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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.

Must not have

Has an active infection requiring systemic therapy.

Prior receipt of cabazitaxel chemotherapy or 2 or more chemotherapy regimens in the mCRPC setting.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (up to 3 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of immune-boosting and chemotherapy drugs in men with aggressive prostate cancers. The treatment aims to strengthen the immune system to fight cancer and directly kill cancer cells.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I have had cabazitaxel or at least two chemotherapy treatments for prostate cancer.

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I have an active tuberculosis infection.

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I have moderate to severe nerve damage.

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I have received an organ or tissue transplant from another person.

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I have HIV with a viral load that isn't under control and a low CD4 count.

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I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation from it.

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I have an immune system disorder or have been on high-dose steroids or other drugs that weaken my immune system recently.

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I have had or currently have lung inflammation treated with steroids.

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I have been treated with specific immune therapy drugs before.

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects who are progression-free and alive (progression-free survival) at 6 months

Secondary study objectives

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

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~4010