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Prostate Cancer MetastaticPhase 2PEAPOD_FOSNCT05563558

Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)

A Phase 2 study testing Pembrolizumab, Carboplatin and Cabazitaxel in people with Prostate Cancer Metastatic, run by Fundacion Oncosur at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
Pembrolizumab, Carboplatin and Cabazitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSpain
Study dates
5 May 2023to 1 Nov 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male participants who are at least 18 years of age on the day of signing informed consent
  • Histologically confirmed diagnosis of adenocarcinoma and/or neuroendocrine carcinoma of the prostate will be enrolled in this study
  • Presence of metastatic disease documented on imaging studies (bone scan, computed tomography (CT) and/or magnetic resonance imaging (MRI) scans
  • At least one of the following Aggressive Variant Prostate Cancer (AVPC) Criteria
  • Histologically proven small cell (neuroendocrine) prostate cancer
  • Exclusive visceral metastases
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  • Predominantly lytic bone metastases
  • Bulky lymph nodes (≥ 5 cm in longest dimension) or high-grade pelvic/prostatic masses
  • Low PSA (≤10 ng/ml) at initial presentation in the presence of extensive disease (≥20 metastases)
  • Elevated serum Lactate Dehydrogenase (LDH) (≥2 x ULN) or carcinoembryonic antigen (CEA) (≥2 x Upper limit (UL))
  • Short time to castration-resistance (≤6 months).
  • Male participants: a male participant must agree to use a contraception as detailed in Appendix 3 of the protocol during the treatment period and for at least after the last dose of study treatment and refrain from donating sperm during this period
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have provided archival tumor tissue sample obtained in the previous year since or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
  • Have adequate organ function as defined in the table 1 of the protocol. Specimens must be collected within 10 days prior to the start of study intervention.
  • Criteria for known Hepatitis B (HBV) and C (HCV) positive subjects
  • Hepatitis B and C screening tests are not required unless:
  • Known history of HBV or HCV infection
  • As mandated by local health authority
  • Hepatitis B positive subjects
  • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
  • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
  • Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. • Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.

Who cannot join

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), OX-40, CD137).
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to informed consent signature.
  • Has received previous treatment with cabazitaxel or carboplatin.
  • Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (non-CNS) disease.
  • Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
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  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, carboplatin or cabazitaxel and/or any of its excipients.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy
  • Has congestive Heart failure New York Heart Association (NYHA) ≥2.
  • Has hypoacusis grade ≥2.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection
  • Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
  • Note: Hepatitis B and C screening tests are not required unless:
  • Known history of HBV and HCV infection
  • As mandated by local health authority
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has had an allogenic tissue/solid organ transplant.

Trial locations and contacts

1 site in 1 country.

Anna Royo contact

680603119

a.royo@evidenze.com

Spain1 site, 1 recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Enrique González Billalabeitia, Dr

    Recruiting

Other trials in Spain

About this study

Official title: A Phase 2 Clinical Trial of Pembrolizumab in Combination With Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer

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.

Read the detailed description

Aggressive variant prostate cancer is a clinically defined subset of metastatic castration resistant prostate cancers characterized by the absence of response to AR targeted agents and neuroendocrine features. The treatments that are currently available are not effective and represent an unmet clinical need. This subgroup has been molecularly characterized and associate loss of key tumor suppressors, including TP53, PTEN and RB, and neuroendocrine features. Carboplatin and cabazitaxel have demonstrated promising activity in this scenario although virtually all patients succumb to the disease. Pembrolizumab has demonstrated activity in neuroendocrine tumors. In this trial will be evaluated the activity and safety of pembrolizumab in combination with the most active chemotherapy regiment available to date in aggressive variant prostate cancer, carboplatin plus cabazitaxel

Being tested
Pembrolizumab, Carboplatin, Cabazitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Included in arm/group description

  • CarboplatinDrug

    Included in arm/group description

  • CabazitaxelDrug

    Included in arm/group description

Study groups in NCT05563558
Study groupRoleWhat they receive
Study ArmExperimental6 cycles of Pembrolizumab+Cabazitaxel+Carboplatin + 15 cycles of Pembrolizumab
Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cabazitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - Adverse Events

    Incidence of adverse events (AEs) graded according to NCI-CTCAE v 5.0 criteria

    Measured: through study completion, an average of 2 years

  2. Efficacy - Radiographic Progression-Free Survival rate

    To assess the safety of pembrolizumab in combination with carboplatin and cabazitaxel according to 6 months Radiographic Progression-Free Survival rate (rPFS) according to the Prostate Cancer Working Group 3 (PCWG3 ).

    Measured: 6 months

Secondary outcomes (6)

  1. Efficacy - Progression Free-Survival

    To determine radiographic Progression Free-Survival at 12 months

    Measured: 12 months

  2. Efficacy - Response rate

    To evaluate response rate by Prostate Cancer Working Group (PCWG) modified RECIST 1.1

    Measured: through study completion, an average of 2 years

  3. Efficacy - PSA response

    To evaluate PSA response (when PSA is evaluable)

    Measured: through study completion, an average of 2 years

  4. Efficacy - PSA progression-free survival

    To determine PSA progression-free survival (PSA-PFS)

    Measured: through study completion, an average of 2 years

  5. Efficacy - progression-free survival

    To determine progression-free survival (PFS)

    Measured: through study completion, an average of 2 years

  6. Efficacy - overall survival

    To determine overall survival (OS)

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start5 May 2023
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563558
Sponsor's protocol ID
PEAPOD_FOS04/2022
Acronym
PEAPOD_FOS
Status last verified
Jun 2024
First submitted
21 Sep 2022
Last updated
11 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Carboplatin and Cabazitaxel in people with Prostate Cancer Metastatic, run by Fundacion Oncosur at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Royo (680603119, a.royo@evidenze.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Adverse Events (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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