Chemoimmunotherapy for Prostate Cancer
(CHAMP Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Andrew J. Armstrong, MD
Must be taking: ADT
Must not be taking: Abiraterone, Enzalutamide, Anti-PD-1, others
Disqualifiers: Immunodeficiency, Active infection, Autoimmune, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received certain prostate cancer therapies or treatments like abiraterone, androgen receptor antagonists, or specific immunotherapies shortly before starting the trial.
What data supports the effectiveness of the drug combination used in the Chemoimmunotherapy for Prostate Cancer trial?
Research shows that cabazitaxel, a component of the treatment, has improved survival in men with advanced prostate cancer who have already received other treatments. Additionally, ipilimumab, another component, has shown activity in prostate cancer, especially in patients with lower disease burden.12345
What safety data exists for chemoimmunotherapy treatments like Cabazitaxel and Ipilimumab in prostate cancer?
What makes the chemoimmunotherapy treatment for prostate cancer unique?
This treatment combines chemotherapy drugs (Cabazitaxel and Carboplatin) with immunotherapy drugs (Ipilimumab and Nivolumab), aiming to enhance the immune system's ability to fight cancer while also directly targeting cancer cells, which is a novel approach compared to standard treatments that typically focus on one method.123510
Research Team
Andrew Armstrong, MD, ScM
Principal Investigator
Duke University
Eligibility Criteria
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.Inclusion Criteria
Life expectancy of over 3 months as determined by treating physician.
I am older than 18 years.
I agree to use effective birth control and not donate sperm while on cabazitaxel treatment.
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Exclusion Criteria
I have not received a live vaccine in the last 30 days.
I am currently being treated for an infection.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive up to 10 cycles of nivolumab, ipilimumab, carboplatin, and cabazitaxel, followed by maintenance nivolumab and ipilimumab
30 weeks
10 cycles of 21 days each
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years
Treatment Details
Interventions
- Cabazitaxel (Chemotherapy)
- Carboplatin (Chemotherapy)
- Ipilimumab (Checkpoint Inhibitor)
- Nivolumab (Checkpoint Inhibitor)
Trial OverviewThe 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.
Participant Groups
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.
Cabazitaxel is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Jevtana for:
- Hormone refractory metastatic prostate cancer
🇺🇸 Approved in United States as Jevtana for:
- Metastatic castration-resistant prostate cancer
🇨🇦 Approved in Canada as Jevtana for:
- Hormone-refractory metastatic prostate cancer
🇯🇵 Approved in Japan as Jevtana for:
- Prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Andrew J. Armstrong, MD
Lead Sponsor
Trials
5
Patients Recruited
150+
Bristol-Myers Squibb
Industry Sponsor
Trials
2731
Patients Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
References
Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1-2 trial. [2021]Taxane-platinum combinations have shown promising activity in metastatic castration-resistant prostate cancers in single-group clinical studies but not in randomised trials. Distinct biological subsets of the disease might derive the greatest benefit from the addition of platinum. We aimed to determine whether adding carboplatin to cabazitaxel would improve the outcomes of men with metastatic castration-resistant prostate cancer.
Ipilimumab in the treatment of prostate cancer. [2018]Ipilimumab (Yervoy(®); Bristol-Myers Squibb, NY, USA) is a fully human monoclonal antibody targeting CTLA-4 and is approved for the treatment of metastatic melanoma. Preclinical and clinical studies have shown its activity in a number of different cancer types, including prostate cancer. Recently, the results from a Phase III study of ipilimumab in prostate cancer patients with prior docetaxel therapy were reported. Although the study did not meet the primary end point of improved overall survival, prespecified subset analyses suggested that ipilimumab may be more active in men with lower disease burden, which suggests that immunotherapy should be tested early in men with castration-refractory prostate cancer. Immune-related adverse events are common and most can be well managed with standard immunosuppressive algorithms.
[Immunotherapy for metastatic prostate cancer: do we really need this?]. [2021]Following the approval of Sipuleucel-T, the development of new immunomodulatory approaches such as ipilimumab and tasquinimod, and the development of new antihormonal drugs (abiraterone acetate, MDV3100, TAK-700), treatment of castration-resistant prostate cancer is finally reaching a new era of management. Docetaxel based chemotherapy remains the standard treatment of choice for patients with a high tumour burden, rapidly progressiong castration resistant prostate cancer, and poorly differentiated prostate cancer. Sipuleucel-T might be an option in the pre-docetaxel management of castration-resistant prostate cancer resulting in a 4-months improvement of overall survival. However, as with all other modalities of immunotherapy patients with good prognostic factors such as minimal tumour burden, slow PSA doubling time, Gleason score ≤ 7, and a long survival probability of > 1 year might be the best candidates taking into account that immunomodulatory approaches demonstrate positive responses after 4-6 months of therapy. Ipilimumab and tasqunimod as inhibitors of the immune checkpoints are additional, promising therapeutic agents with high clinical potential. It is the aim of the current article to critically review the current options of immune therapy in men with castration resistant prostate cancer.
Cabazitaxel (jevtana): a novel agent for metastatic castration-resistant prostate cancer. [2023]This article presents current clinical evidence supporting the use of cabazitaxel (Jevtana) in men with metastatic castration-resistant prostate cancer (mCRPC).
[Cabazitaxel after docetaxel: a new option in metastatic castration-resistant prostate cancer]. [2018]The management of patients with metastatic castration-resistant prostate cancer is a real challenge. Indeed, after a first line chemotherapy with docetaxel, there was no standard because the treatments were ineffective. Today, several therapeutic options are available with the development of new therapies. Among them, cabazitaxel, semi-synthetic derivative of a natural taxoid, has been developed to its low recognition by the MDR system and power distribution including brain. This new chemotherapy was assessed in patients with metastatic castration-resistant prostate cancer whose disease has progressed during or after docetaxel-based therapy. Treatment with cabazitaxel plus prednisone has improved overall survival of 2.4 months compared to mitoxantrone in the TROPIC phase III. However, hematologic toxicity may be limiting with a risk of febrile neutropenia; hematopoietic growth factors are advised in case of significant neutropenia. The cabazitaxel, Jevtana(®), has been approved in second line after docetaxel. Its position in relation to new types of hormone therapy, as abiraterone acetate, in the same indication requires further investigations, including predictive factors of response. Studies are on going in first line indication (compared to docetaxel) and associated to other new hormone therapies.
Final quality of life and safety data for patients with metastatic castration-resistant prostate cancer treated with cabazitaxel in the UK Early Access Programme (EAP) (NCT01254279). [2022]To compile the safety profile and quality of life (QoL) data for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel in the UK Early Access Programme (UK EAP).
Cabazitaxel in patients aged ≥80 years with castration-resistant prostate cancer: Results of a post-marketing surveillance study in Japan. [2021]Data on the safety and efficacy of cabazitaxel in patients aged ≥80 years with castration-resistant prostate cancer (CRPC) are limited. We report the safety (adverse drug reactions [ADRs]) and efficacy (overall survival [OS], time to treatment failure [TTF], and prostate-specific antigen [PSA] response rates) in patients aged
Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021). [2022]Patients with metastatic castration-resistant prostate cancer have few treatment options after novel hormonal therapy (eg, abiraterone or enzalutamide). We aimed to evaluate cabozantinib, a tyrosine kinase inhibitor with immunomodulatory properties, in combination with the PD-L1 inhibitor atezolizumab in metastatic castration-resistant prostate cancer.
Review of immune-related adverse events in prostate cancer patients treated with ipilimumab: MD Anderson experience. [2022]Targeting a T-cell inhibitory checkpoint with the anti-CTLA-4 monoclonal antibody, ipilimumab, represents a scientific breakthrough in immunotherapy for the treatment of cancer. However, ipilimumab therapy is also associated with unique side effects, known as immune-related adverse events (irAEs), which need to be recognized and managed with immunosuppressive agents. To date, the majority of our knowledge regarding ipilimumab-associated side effects is based upon clinical studies in melanoma. Here we provide a review of ipilimumab-induced irAEs and our experience in a cohort of 44 patients with prostate cancer who were treated at the MD Anderson Cancer Center on two different clinical trial protocols.
[Current status and prospects of immunotherapy for castration-resistant prostate cancer]. [2014]Surgery, radiation and chemotherapy are three major therapies for cancer. But now, hope is being gathered in immunotherapy as a treatment for fourth. Immunotherapy has been done than before, but they are non-specific immunotherapy. Those that have become hot topics are specific immunotherapies targeting certain molecules or antigens. In this chapter, current status and prospects of immunotherapy for castration-resistant prostate cancer (CRPC) are described. As concrete examples, Sipuleucel-T(Provenge), GVAX, PROSTVAC-VF, Ipilimumab (anti-CTLA-4 mAb), anti-PD-1 mAb and anti-PSMA mAb are cited. As a result, it is not obtained results which therapy also satisfactory at present. Because of its uncertainties we are in the developmental stages of this therapy and improved outcomes might be achievable.