Actively Recruiting
Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)
Led by Fundacion Oncosur · Updated on 2024-06-11
42
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
It is a Phase 2 clinical trial of Pembrolizumab in combination with Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer. It is divided into two parts: an induction period of 6 cycles of 3 weeks each cycle of Pembrolizumab+Cabazitaxel+Carboplatino and a maintenance phase of 15 cycles of 6 weeks each cycle of Pembrolizumab.
CONDITIONS
Official Title
Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older at the time of informed consent
- Histologically confirmed adenocarcinoma and/or neuroendocrine carcinoma of the prostate
- Presence of metastatic disease confirmed by imaging (bone scan, CT, or MRI)
- Meet at least one Aggressive Variant Prostate Cancer (AVPC) criterion such as small cell prostate cancer, exclusive visceral metastases, predominantly lytic bone metastases, bulky lymph nodes or high-grade pelvic/prostatic masses, low PSA (≤10 ng/ml) with extensive disease (≥20 metastases), elevated LDH or CEA levels, or short time to castration-resistance (≤6 months)
- Agree to use contraception during treatment and for a period after the last dose if sexually active
- Provide written informed consent
- Have measurable disease per RECIST 1.1 criteria
- Provide archival or newly obtained tumor tissue sample
- ECOG performance status of 0 to 1 within 7 days prior to first dose
- Adequate organ function as defined in the protocol
- For Hepatitis B or C positive participants, meet specific viral load and treatment criteria
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Received systemic anti-cancer therapy including investigational agents within 4 weeks prior to consent
- Prior treatment with cabazitaxel or carboplatin
- Radiotherapy within 2 weeks before study start or unresolved radiation toxicities
- Live vaccine within 30 days before first study dose
- Participation in another investigational study within 4 weeks prior to first dose
- Diagnosis of immunodeficiency or chronic systemic steroid/immunosuppressive therapy within 7 days prior to study drug
- Active progressing malignancy requiring treatment within the past 5 years (except certain skin cancers)
- Active CNS metastases or carcinomatous meningitis unless stable and steroid-free for specified periods
- Severe hypersensitivity to study drugs or their components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Congestive heart failure NYHA class 2 or higher
- Hearing loss grade 2 or higher
- Known HIV infection
- Concurrent active Hepatitis B or C infection
- Conditions or therapies that may interfere with study participation
- Psychiatric or substance abuse disorders interfering with cooperation
- History of allogenic tissue or solid organ transplant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
Research Team
A
Anna Royo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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