BADANIA KLINICZNE PROWADZONE W POLSCE

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REKRUTACJA ZAKOŃCZONA


An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer - NCT04577833

https://clinicaltrials.gov/ct2/show/NCT04577833

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REKRUTACJA ZAKOŃCZONA


A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors - NCT03729596


Retifanlimab (previously known as MGA012) is an investigational, humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement
https://www.macrogenics.com/mga012-pd-1/


MGC018 (B7-H3)
MGC018 is an investigational antibody-drug conjugate (ADC) comprised of a humanized B7-H3 monoclonal antibody (mAb) conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. MGC018 is designed to target solid tumors expressing B7-H3.
https://www.macrogenics.com/mgc018-b7-h3/


Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)
https://www.businesswire.com/news/home/ ... inoma-SCAC


FDA Grants Priority Review for Retifanlimab for Advanced Squamous Cell Carcinoma of the Anal Canal
https://www.targetedonc.com/view/fda-gr ... anal-canal

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REKRUTACJA ZAKOŃCZONA


A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer - CONTACT-02 - NCT04446117

[https://clinicaltrials.gov/ct2/show/results/NCT04446117

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W uproszczeniu - zadaniem MDG019 jest wzmocnienia przeciwnowotworowej odpowiedzi układu odpornościowego.



W pierwszej fazie badania MDG019 był podawany, między innymi, pacjentom z mCRPC z 18 pacjentów, którzy mogli być ewaluowani, 4 odpowiedziało na leczenie, w tym 1 pacjent z rakiem prostaty - potwierdzona całkowita remisja.


REKRUTACJA ZAKOŃCZONA

A Phase 1, First-in-Human, Open-Label, Dose Escalation and Cohort Expansion Study of MGD019, a Bispecific DART® Protein Binding PD-1 and CTLA-4 in Patients With Unresectable or Metastatic Neoplasms

https://clinicaltrials.gov/ct2/show/NCT03761017




Wyniki drugiego etapu pierwszej fazy (czyli eskalacji dawki) zostaly omówione w artykule z września 2020.


Sep 20, 2020
MacroGenics Announces Presentation of MGD019 Phase 1 Data at the ESMO Virtual Congress 2020

=> MGD019 well-tolerated with early signals of activity in advanced solid tumors not typically responsive to checkpoint inhibition
=> Recommended Phase 2 dose established for MSS CRC, NSCLC expansion cohorts
(...)
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced clinical data from the dose escalation portion of a Phase 1 clinical trial of MGD019.
The proffered paper session titled, “A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD019, an Investigational Bispecific PD-1 × CTLA-4 DART® Molecule in Patients with Advanced Solid Tumors,” was presented orally at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 20, 2020, by Dr. Manish R. Sharma, Associate Director of Clinical Research at START Midwest in Grand Rapids, Michigan.

MGD019, a bispecific PD-1 × CTLA-4 DART molecule, was designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells.

Forty-three patients were enrolled in the Phase 1 dose escalation study of MGD019 within a dose range of 0.03 – 10.0 mg/kg, administered every three weeks initially, in a population of heavily pre-treated patients representing a broad range of different types (23) of solid tumors.
There were no dose-limiting toxicities (DLTs).
A total of 28 patients were treated at doses ≥ 3.0 mg/kg administered every three weeks initially.
MGD019 was well-tolerated in patients who received less than 10 mg/kg; the most common treatment-related adverse events over this dosing range were pruritus (23.3%), arthralgia (18.6%), fatigue (18.6%), rash (18.6%), nausea (16.3%) and infusion-related reaction (16.3%). Several Grade 3 adverse events were observed at the 10.0 mg/kg level; however, none were considered dose limiting.
(...)
Of the 18 evaluable patients who received doses ≥ 3.0 mg/kg as of the July 21, 2020 cut-off date, four objective responses have been reported in this trial, including a confirmed complete response in metastatic castration-resistant prostate cancer (mCRPC), confirmed partial responses in microsatellite stable colorectal cancer (MSS CRC) and metastatic type AB thymoma, and an unconfirmed partial response in serous fallopian tube carcinoma.
(...)
http://ir.macrogenics.com/news-releases ... -data-esmo

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BADANIE ZAKOŃCZONE
Terminated by Sponsor for various factors including prolonged duration and enrollment challenges


PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) NCT03850795

https://clinicaltrials.gov/ct2/show/NCT03850795



____________EDIT (03/12/2021______________
FYI

HC-1119 = deuterowany enzalutamid

Lek deuterowany to drobnocząsteczkowy produkt leczniczy, w którym jeden lub więcej atomów wodoru zawartych w cząsteczce leku zostało zastąpionych jego cięższym, stabilnym izotopem deuteru.
Ze względu na kinetyczny efekt izotopowy, leki zawierające deuter mogą mieć znacznie niższe tempo metabolizmu, a tym samym dłuższy okres półtrwania.
-zb

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BADANIE KLINICZNE KEYNOTE-365 W DALSZYM CIĄGU PROWADZI REKRUTACJĘ



KEYNOTE-365:
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) NCT02861573


Brief Summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be nine cohorts in this study:

Cohort A will receive pembrolizumab + olaparib,
Cohort B will receive pembrolizumab + docetaxel + prednisone,
Cohort C will receive pembrolizumab + enzalutamide,
Cohort D will receive pembrolizumab + abiraterone + prednisone
Cohort E will receive pembrolizumab + lenvatinib,
Cohort F will receive pembrolizumab + lenvatinib,
Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A),
Cohort H will receive pembrolizumab/vibostolimab coformulation, and
Cohort I will receive pembrolizumab + carboplatin + etoposide in Arm 1 and carboplatin + etoposide in Arm 2.


Criteria

Inclusion Criteria:

=> For Cohorts A, B, C, D, E, G: Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology

=> For Cohorts F, H, I: Has t-NE prostate cancer defined by ≥1% neuroendocrine cells in a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrolment

=> Is able to provide tumor tissue from a site not previously irradiated as follows:
> Cohorts A, E, and G: must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC;
> Cohort B: must provide an archival tumor tissue sample or tumor tissue from a newly obtained core or excisional biopsy from soft tissue if the lesion is clinically accessible;
> Cohorts C and D with soft tissue disease: must provide a core or excisional biopsy from a soft tissue lesion if clinically accessible within 1 year of screening and after developing mCRPC and an archival specimen if available; and
> Cohorts F, H, and I must provide a core or excisional biopsy from soft tissue or a bone biopsy.

Participants with bone metastasis only must provide an archival tumor tissue specimen

=> Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following:
> PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL;
> radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; > radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression

=> Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM).
Treatment with luteinizing hormone-releasing hormone agonists or antagonists for all Cohorts must have been initiated ≥4 weeks prior to first dose of study therapy and must be continued throughout the study

> For Cohort A: Has received docetaxel for mCRPC.
Prior treatment with 1 other chemotherapy for mCRPC is allowed.
Up to 2 second-generation hormonal manipulations (e.g., abiraterone acetate and/or enzalutamide) are allowed. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to day 1 of Cycle 1

> For Cohort B: Has received prior treatment with either abiraterone acetate or enzalutamide (but not both) in the prechemotherapy mCRPC state. Participants in Cohort B must have received at least 4 weeks of either abiraterone or enzalutamide treatment (but not both) who failed treatment or became intolerant of the drug

> For Cohort C: Has received prior treatment with abiraterone acetate in the pre-chemotherapy mCRPC state without prior enzalutamide. Participants in Cohort C must have received at least 4 weeks of abiraterone treatment who failed treatment or become intolerant of the drug. Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible

> For Cohort D: Has not received chemotherapy for mCRPC and has either not had prior second generation hormonal manipulation for mCRPC OR has previously been treated with enzalutamide for mCRPC and failed treatment or has become intolerant of the drug.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel.
Prior treatment with abiraterone acetate in the hormone-sensitive metastatic setting is allowed as long as there was no progression on this agent and abiraterone acetate was not discontinued due to adverse events (AEs)

> For Cohorts E, F, and H: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide or other next-generation hormonal agents [NHA]) are allowed.
Participants who received prior ketoconazole for metastatic disease may be enrolled.
If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1

> For Cohorts G and I: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, or other NHA) are allowed.
Participants who received prior ketoconazole for metastatic disease may be enrolled. I
If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1

> For Cohorts H and I: Has aggressive disease progression manifested by progression within 6 months of starting next-generation hormonal agents (NHA) for metastatic hormone-sensitive prostate cancer (mHSPC) or mCRPC and progression within <6 cycles of docetaxel treatment for mCRPC (docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC)


Exclusion Criteria:

=> Has had prior chemotherapy, targeted small molecule therapy abiraterone treatment, enzalutamide treatment, or radiation therapy within 2 weeks prior to first dose of study therapy or who has not recovered (ie, Grade ≤1 or at baseline) from AEs due to a previously administered agent

=> Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated

For Cohort B: Has received prior treatment with docetaxel or another chemotherapy agent for metastatic prostate cancer

For Cohort C: Has received prior chemotherapy for mCRPC.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks elapsed from last dose of docetaxel.
Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible


Poland
MSD Polska Sp. Z o.o. Recruiting
Warsaw, Poland
Contact: Thomas Johansson 48 22ý478 43 24

https://clinicaltrials.gov/ct2/show/NCT02861573

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REKRUTACJA ZAKOŃCZONA


AMPLITUDE:
A Phase 3 Randomised Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) NCT04497844

https://clinicaltrials.gov/ct2/show/NCT04497844

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REKRUTACJA ZAKOŃCZONA

Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC
NCT04887506

https://clinicaltrials.gov/ct2/show/NCT04887506

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REKRUTACJA ZAKOŃCZONA

PSMAddition:
An Open-label, Randomised Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) NCT04720157


https://clinicaltrials.gov/ct2/show/NCT04720157

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REKRUTACJA ZAKOŃCZONA

PSMAfore: A Phase III, Open-label, Multi-Center, Randomised Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer
NCT04689828

https://clinicaltrials.gov/ct2/show/NCT04689828

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REKRUTACJA ZAKOŃCZONA


A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH (NCT04597125)

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8

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REKRUTACJA ZAKOŃCZONA


A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer - NCT04123366

https://clinicaltrials.gov/ct2/show/NCT04123366





_________________________________

Wszyscy pacjenci z przerzutowym rakiem prostaty w momencie diagnozy oraz pacjenci z progresją podczas leczenia antyandrogenami II generacji (abirateron/enzalutamid) powinni być testowani na obecność mutacji HRR.
NCCN zaleca testowanie wszystkich pacjentów z mCRPC.



HRRm Testing – Metastatic Prostate Cancer – LYNPARZA® (olaparib)

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer recommend tumor testing for HRRm for any patient with mCRPC.


WHO should be tested for HRRm?

Test all patients with advanced prostate cancer at metastatic diagnosis or upon progression with enzalutamide or abiraterone.


Test for HRR gene mutations

Using FDA-approved companion diagnostics for LYNPARZA:
- FoundationOne® CDx
- FoundationOne® Liquid CDx
- Myriad BRACAnalysis CDx®



HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

ADVERSE REACTIONS — HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA for PROfound were:
anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for PROfound were:
decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

https://www.lynparzahcp.com/metastatic- ... sting.html

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Wykaz badań klinicznych dotyczących CaP zarejestrowanych na amerykańskiej stronie clinicaltrilas.gov aktualnie prowadzących rekrutuję w Polsce (stan na 04.02.2022).

Informacje dot. kryteriów kwalifikacyjnych poszczególnych badań znajdują się w postach powyżej (jedno badanie = jeden post).

Informacje są wprawdzie w języku angielskim, ale można je w ułamku sekundy przetłumaczyć na język polski używając Google Translate https://translate.google.com

CaP_Badania Kliniczne w PL_04.02.2022.pdf

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BADANIE KLINICZNE FUZULOPARIB + ZYTIGA vs ZYTIGA PROWADZI REKRUTACJĘ



A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer - NCT04691804

Criteria

Inclusion Criteria
=> Able and willing to provide a written informed consent
=> A score of 0 to 1 for ECOG performance status
(...)
=> Prostate adenocarcinoma confirmed
=> Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy.
=> The functional level of the organs must meet the requirements
=> Blood and tumor tissue samples are provided during screening to determine the DRD status


Exclusion Criteria
=> Prior treatment with any PARP inhibitor
=> Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC stage
=> Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose
=> Plan to receive any other anti-tumor treatment
=> Presence of radiologically confirmed tumor lesions in the brain
=> Contraindications to the use of Prednisone
=> History of uncontrolled pituitary or adrenal dysfunction
=> Uncontrolled hypertension
=> Presence of active heart diseases
=> Human immunodeficiency virus-positive
=> Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption
=> Active HBV or HCV infection
=> Presence of concomitant diseases


Poland

Szpitale Pomorskie Sp.zo.o Recruiting
Gdynia, Poland
Principal Investigator: Iwona Danielewicz

Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego Recruiting
Grudziadz, Poland
Principal Investigator: Urszula Sadowska

Clinical Research Center Sp. z o.o. Recruiting
Kobylniki, Poland
Principal Investigator: Ilona Bar Letkiewicz

Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika Recruiting
Koszalin, Poland
Principal Investigator: Mariusz Kwiatkowski '

University Hospital Recruiting
Krakow, Poland
Principal Investigator: Piotr Wysocki

Szpital Kliniczny Nr Pozna? Recruiting
Poznan, Poland
Principal Investigator: Piotr Tomczak

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie Not yet recruiting
Warszawa, Poland
Principal Investigator: Pawel Wiechno

Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center Not yet recruiting
Wroclaw, Poland
Principal Investigator: Krzysztof Tupikowski


https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8

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REKRUTACJA ZAKOŃCZONA

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3) NCT05288166

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8

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BADANIA KLINICZNE PROWADZONE W POLSCE ZAREJESTROWANE NA AMERYKANSKIEJ STRONIE clinicaltrials.gov
(stan na 18.09.2022)


LISTA BADAŃ KLINICZNYCH PROWADZONYCH W POLSCE DLA PACJENTÓW z CRPC (rakiem prostaty opornym na kastrację)

ClinicalTrials_CRPC_18.09.2022_PL.pdf

LISTA BADAŃ KLINICZNYCH PROWADZONYCH W POLSCE DLA PACJENTÓW z HSCP (rakiem prostaty wrażliwym na kastrację)

ClinicalTrials_HSCP_18.09.2022_PL.pdf

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REKRUTACJA ZAKOŃCZONA

PROTEUS
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy NCT03767244

https://clinicaltrials.gov/ct2/show/NCT ... =2&rank=13

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CaP_badania kliniczne_PL_24.06.2024.pdf

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An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer (PSMACare) NCT05849298


Key Inclusion criteria

- Participants must be adults ≥ 18 years of age with signed informed consent prior to participation to study
- Histologically or cytologically confirmed prostate cancer
- Participants must have ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy
- Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy
- Participants must have evidence of PSMA-positive disease as seen on a AAA517 or piflufolastat F 18 PET/CT scan at baseline as determined by Blinded Independent Central Review (BICR) based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018). Participants with M1 disease only on PSMA PET scan are allowed to participate
- Participants must have a negative conventional imaging for M1 disease.
- PSA Doubling Time (PSADT) of ≤ 10 months
- Participants must have adequate organ functions: bone marrow reserve, hepatic & renal


Key Exclusion criteria

- Prior or present evidence of metastatic disease as assessed by CT/MRI locally for soft tissue disease and whole-body radionuclide bone scan for bone disease. Exception: Participants with soft tissue pelvic disease may be eligible (e.g., participants with enlarged lymph nodes below the aortic bifurcation (N1) are eligible if the short axis of the largest lymph node is <20 mm)

- Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable with best available standard of care (incl. pads, drainage) are allowed

- Active clinically significant cardiac disease; history of seizure or condition that may pre-dispose to seizure which may require treatment with surgery or radiation therapy

- Prior therapy with:
* second generation anti-androgens (e.g., enzalutamide, apalutamide and darolutamide); CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galeterone, ketoconazole;
* radiopharmaceutical agents (e.g., Strontium-89), PSMA-targeted radioligand therapy;
* immunotherapy (e.g., sipuleucel-T);
* chemotherapy, except if administered in the adjuvant/neoadjuvant setting, completed > 2 years before randomization;
* any other investigational agents for CRPC;
* use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) or
* first-generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) within 28 days before randomization;
* radiation therapy (external beam radiation therapy [EBRT] and brachytherapy within 28 days before randomization

- Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, biological therapy or investigational therapy

Poland

Kielce, Poland, 25-640 Recruiting
Novartis Investigative Site

Krakow, Poland, 31-501 Recruiting
Novartis Investigative Site


https://clinicaltrials.gov/study/NCT058 ... d=Prostate

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A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (CAPItello280) NCT05348577


Inclusion Criteria:

- Histologically-confirmed prostate adenocarcinoma without predominant neuroendocrine or small cell cancers

- Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable or non-measurable)

- Patient must have been previously treated with a next generation hormonal agent (NHA), ie, abiraterone, enzalutamide, apalutamide or darolutamide, for prostate cancer for at least 3 months and shown evidence of disease progression (radiological or via PSA assessment) while receiving the NHA

- Evidence of mCRPC with progression of disease despite androgen deprivation therapy (ADT)

- Serum testosterone level ≤ 50 ng/dL

- Candidate for docetaxel and steroid therapy

- Ongoing ADT with LHRH agonist, LHRH antagonist, or bilateral orchiectomy

- Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1 and anticipated minimum life expectancy of 12 weeks
- Confirmation that archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample which meets the minimum pathology and sample requirements is available to send to the central laboratory
- Able and willing to swallow and retain oral medication
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm


Exclusion Criteria:

- Radiotherapy with a wide field of radiation within 4 weeks before start of study treatment
- Major surgery (excl. placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, internal stents) within 4 weeks of start of study treatment
- Brain metastases,or spinal cord compression (unless spinal cord compression is asymptomatic and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)'

- Any of the following cardiac criteria:
i. Mean resting corrected QT interval (QTc) >470 msec from 3 consecutive ECGs
ii. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
iii. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age,or any concomitant medication known to prolong the QT interval
iv. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade ≥2
v. Symptomatic hypotension - systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg vi. haemodinamic instability

- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
i. Patients with diabetes mellitus (DM) type 1 or DM type 2 requiring insulin treatment
ii. HbA1c ≥8.0% (63.9 mmol/mol)

- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
i. Absolute neutrophil count < 1.5x 10^9/L
ii. Platelet count < 100x 10^9/L
iii. Haemoglobin < 9 g/dL (< 5.59 mmol/L)
iv. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases.
Elevated alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigator's judgement
v. Total bilirubin > 1.5x ULN (participants with confirmed Gilbert's syndrome may be included in the study with a higher value)
vi. Creatinine clearance < 50 mL/min per the Cockcroft and Gault formula without the need for chronic dialysis;

- As judged by the investigator, any evidence of diseases (including severe or uncontrolled systemic diseases, uncontrolled hypertension, history of interstitial pneumonia / pneumonitis or interstitial lung disease, renal transplant and active bleeding diseases), which, in the investigator's opinion, makes it undesirable for the patient to participate in the study or that would jeopardise compliance with the protocol.

- Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib

- Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent.

- Previous allogeneic bone marrow transplant or solid organ transplant

- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.

- Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy, excluding alopecia. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included (eg, hearing loss)

- Known to have active hepatitis infection.

- Known to have human immunodeficiency virus (HIV) with a detectable viral RNA load or a CD4+ T-cell count < 350 cells/uL or a history of an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, or receiving anti-HIV medications for less than 4 weeks.

- Known to have active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).


- Treatment with any of the following:
i. Prior chemotherapy for CRPC. Chemotherapy for metastatic or localized HSPC (including docetaxel) is allowed provided that chemotherapy was completed ≥ 6months before randomisation and progression of the prostate cancer occurred ≥ 6months after the completion of therapy.
ii. Prior exposure to AKT inhibitors or PI3K inhibitors
iii. Any investigational agents or study drugs from a previous clinical study within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment
iv. Any other immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents (except ADT) within 3 weeks of the first dose of study treatment
v. Strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort),
vi.Use of any live vaccine administration 30 days prior to the initiation of study treatment, during, and for at least 90 days after the last dose of the study treatment

- Drugs known to significantly prolong the QT interval and associated with Torsade de Pointes within 5 half-lives of the first dose of study treatment

- History of hypersensitivity to active or inactive excipients of capivasertib, docetaxel, or drugs with a similar chemical structure or class
Any restriction or contraindication based on the local prescribing information that would prohibit the use of docetaxel



Poland

Lodz, Poland, 93-513
Recruiting
Research Site

Nowa Sol, Poland, 67-106 Recruiting
Research Site

Opole, Poland, 45-061 Recruiting
Research Site

Warszawa, Poland, 02-781 Recruiting
Research Site

Wieliszew, Poland, 05-135 Recruiting
Research Site

https://clinicaltrials.gov/study/NCT053 ... d=Prostate



FYI:

TRUQAP® (capivasertib) to lek przeciwnowotworowy, który blokuje aktywność białka zwanego AKT, które jest ważne dla wzrostu i przeżycia komórek. AKT często wykazuje nadmierną aktywność w komórkach nowotworowych, pomagając im rosnąć i przetrwać. Capivasertib może zatrzymać wzrost komórek nowotworowych poprzez blokowanie AKT. W badaniach laboratoryjnych i na modelach zwierzęcych wykazano jego skuteczność w ograniczaniu wzrostu komórek nowotworowych.

TRUQAP® (capivasertib) jest obecnie stosowany w kombinacji z fulvestrantem w przypadku lokacie zaawansowanego lub przerzutowego HR dodatniego, HER2 negatywnego raka piersi.


Poniżej zamieszczam australijską ulotkę leku Truqap:

TRUQAP_capivasertib .pdf

[zosia bluszcz]

UWAGA - REKRUTACJA W POLSCE JESZCZE SIĘ NIE ROZPOCZĘŁA

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-PR01) NCT06120491


Inclusion Criteria:

- Male ≥ 18 years of age
- Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
- Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
- Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to randomisation
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
- Provision of FFPE tumour tissue sample and blood sample (for ctDNA)
- Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility
- Adequate organ and bone marrow function as described in study protocol
- Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
- Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.


Exclusion Criteria:

- Participants with a history of MDS/AML or with features suggestive of MDS/AML
- Participants with any known predisposition to bleeding
- Any history of persisting (> 2 weeks) severe cytopenia
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
- History of another primary malignancy, with exceptions
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention
- Cardiac criteria, including history of arrythmia and cardiovascular disease
- Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions:
- Prior treatment within 14 days with blood product support or growth factor support.
- Participants who are unevaluable for both bone and soft tissue progression


Poland

Bydgoszcz, Poland, 85-796 Not yet recruiting
Research Site

Koszalin, Poland, 75-581 Not yet recruiting
Research Site

Poznań, Poland, 61-731 Not yet recruiting
Research Site

Rzeszów, Poland, 35-001 Not yet recruiting
Research Site

Szczecin, Poland, 71-730 Not yet recruiting
Research Site

Warszawa, Poland, 04-073 Not yet recruiting
Research Site

Wrocław, Poland, 53-329 Not yet recruiting
Research Site

Żory, Poland, 44-240 Not yet recruiting
Research Site


https://clinicaltrials.gov/study/NCT061 ... d=Prostate

[zosia bluszcz]

A Phase 3 Randomized, Open-label Study of MK-5684 (Opevesostat) Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy NCT06136624


Inclusion Criteria:

- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
- Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
- Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
- Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and - has had progressive disease (PD) during or after treatment
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
- Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
- Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
- Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
- If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment
- Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
- Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
- Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: - EITHER be abstinent OR must agree to use male condom


Exclusion Criteria:

- Has a gastrointestinal disorder that might affect absorption
- Has a history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level
- Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
- Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
- Has a history of clinically significant ventricular arrhythmias
- Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
- Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications
- Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate) within 4 weeks before the date of randomization
- Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
- Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
- Has received colony-stimulating factors within 28 days before the date of randomization
- Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
- Has a "superscan" bone scan
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has an active infection requiring systemic therapy
- Has concurrent active HBV or known active HCV infection
- Has a history of long QTc syndrome
- Has any of the following at Screening Visit: hypotension (systolic BP <110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
- Is unable to swallow capsules/tablets
- Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
- Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle [Silybum marianum])
- Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention


Poland


Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796 Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302)
Contact: Study Coordinator 48501446778

Siedlce, Mazowieckie, Poland, 08-110 Recruiting
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310)
Contact: Study Coordinator 48698826497

Kielce, Swietokrzyskie, Poland, 25-734 Recruiting
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch
Contact: Study Coordinator +48885997850


Koszalin, Zachodniopomorskie, Poland, 75-581 Recruiting
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303)
Contact: Study Coordinator 48502204953

https://clinicaltrials.gov/study/NCT061 ... d=Prostate



OPEVESOSTAT

Merck and Orion Announce Mutual Exercise of Option Providing Merck Global Exclusive Rights to Opevesostat, an Investigational CYP11A1 Inhibitor, for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Opevesostat is an oral, non-steroidal and selective inhibitor of CYP11A1 discovered and developed by Orion and is being investigated for the treatment of hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 activity, opevesostat is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

https://www.merck.com/news/merck-and-or ... istant-pr/

[zosia bluszcz]

Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) NCT06353386

Experimental: Arm A1: Opevesostat
Experimental: Arm A2: Olaparib + Opevesostat
Experimental: Arm A3: Docetaxel + Opevesostat
Experimental: Arm A4: Cabazitaxel + Opevesostat


The main inclusion criteria include but are not limited to the following:

- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
- Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
- Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
- Current evidence of metastatic disease.
- Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
- Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization.
- Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to <Grade 1 or baseline.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.



The main exclusion criteria include but are not limited to the following:

- History of pituitary dysfunction.
- Poorly controlled diabetes mellitus.
- Active or unstable cardio/cerebro-vascular disease, including thromboembolic events.
- History or family history of long corrected QT interval (QTc) syndrome.
- Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
- History or current condition of adrenal insufficiency.
- History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
- Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
- Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed.
- Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Active infection requiring systemic therapy.
- Concurrent active HBV and HCV infections


Poland

Warszawa, Mazowieckie, Poland, 02-781 Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400
Contact: Study Coordinator 48504340022

https://clinicaltrials.gov/study/NCT063 ... d=Prostate