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

NCT05563558 | Recruiting Phase 2

• 1 other identifier: PEAPOD_FOS04/2022
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 15 cycles of 6 weeks each cycle of Pembrolizumab.

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• Safety - Adverse Events

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

  through study completion, an average of 2 years

• 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 ).

  6 months

Secondary Outcomes (6)

• Efficacy - Progression Free-Survival

  12 months

• Efficacy - Response rate

  through study completion, an average of 2 years

• Efficacy - PSA response

  through study completion, an average of 2 years

• Efficacy - PSA progression-free survival

  through study completion, an average of 2 years

• Efficacy - progression-free survival

  through study completion, an average of 2 years

Other Outcomes (2)

• Exploratory objective - Correlation of efficacy endpoints with AVPC- Molecular-Classification (MC)

  through study completion, an average of 2 years

• Exploratory objective - Correlation of efficacy endpoints with neuroendocrine signature

  through study completion, an average of 2 years

Study Arms (1)

Study Arm

EXPERIMENTAL

6 cycles of Pembrolizumab+Cabazitaxel+Carboplatin + 15 cycles of Pembrolizumab

Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cabazitaxel

Interventions

Pembrolizumab DRUG

Included in arm/group description

Study Arm

Carboplatin DRUG

Included in arm/group description

Study Arm

Cabazitaxel DRUG

Included in arm/group description

Study Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fundacion Oncosur: lead

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

MeSH Terms

Interventions

pembrolizumab; Carboplatin; cabazitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Enrique Gonzalez-Billalabeitia, Dr

  Hospital Universitario 12 de Octubre, Madrid

  PRINCIPAL INVESTIGATOR

• Teresa Alonso Gordoa, Dr

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

• Álvaro Pinto Marín, Dr

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Ignacio Durán Martínez, Dr

  Hospital Universitario Marqués de Valdecilla

  PRINCIPAL INVESTIGATOR

• Begoña Mellado González, Dr

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• David Lorente Estellés, Dr

  Hospital Provincial De Castellón

  PRINCIPAL INVESTIGATOR

• Albert Font Pous, Dr

  ICO- Badalona

  PRINCIPAL INVESTIGATOR

• Sergio Vazquez Estévez, Dr

  Hospital Lucus Augusti

  PRINCIPAL INVESTIGATOR

• Javier Puente, Dr

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Royo

CONTACT

680603119; a.royo@evidenze.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 3, 2022
• Study Start: May 5, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

ES (1)