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    Summary
    EudraCT Number:2021-001291-42
    Sponsor's Protocol Code Number:MK-3475-C51
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-001291-42
    A.3Full title of the trial
    Radiotherapy in combination with pembrolizumab in patients with PSA persistence or biochemical recurrence after radical prostatectomy due to prostate cancer
    Behandlung von Patienten mit einem persistierenden PSA Wert oder einem biochemischen Rezidiv nach vorheriger kompletter Entfernung der Prostata mit einer Kombination aus Pembrolizumab und Salvage-Strahlentherapie (SRT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of radiotherapy in combination with pembrolizumab in patients with recurrent prostate cancer after radical prostatectomy
    Behandlung von wiederkehrendem Prostatakrebs nach kompletter Entfernung der Prostata mit einer Kombination aus Pembrolizumab (KEYTRUDA°®) und Salvage-Strahlentherapie (SRT)
    A.3.2Name or abbreviated title of the trial where available
    Pembro-SRT
    Pembro-SRT
    A.4.1Sponsor's protocol code numberMK-3475-C51
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversitätsklinikum Freiburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMSD Sharp & Dohme GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Freiburg
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHugstetter Straße 55
    B.5.3.2Town/ cityFreiburg i. Br.
    B.5.3.3Post code79106
    B.5.3.4CountryGermany
    B.5.4Telephone number0049761270-28900
    B.5.5Fax number0049761270-28708
    B.5.6E-mailchristian.gratzke@uniklinik-freiburg.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name KEYTRUDA (pembrolizumab, MK3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPembrolizumab
    D.3.9.1CAS number L01XC18
    D.3.9.3Other descriptive nameMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent prostate cancer - Patients with biochemical recurrence (BCR) or persisting prostate-specifiv antigen (PSA) after radical prostatectomy (RP)
    Patienten mit Rezidiv bzw. eines persistierenden PSA Wertes nach kompletter Entfernung der Prostata
    E.1.1.1Medical condition in easily understood language
    Recurrent prostate cancer
    Wieder aufflammender Prostatakrebs
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of pembrolizumab in combination with standard salvage radiatiion therapy (SRT) in patients with biochemical recurrence (BCR) of prostate-specific antigen (PSA) persistenca after radical prostatectomy (RP).
    Not applicable
    E.2.2Secondary objectives of the trial
    Not applicable
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male patients who are at least 18 years of age on the day of signing informed consent.
    2.Histologically confirmed diagnosis of an adenocarcinoma of the prostate and a BCR or PSA persistence after RP.
    3.Histology of the RP specimen needs to fulfill the following criteria: adenocarcinoma of the prostate, Gleason score 7-10; pNX or pN0 or pN1 (max. 2 lymph nodes involved).
    4.Imaging within 50 days prior to study inclusion (patient registration) is mandatory ([68Ga] or [18F] PSMA PET-CT as standard imaging modality, alternatively CT abdomen and full-body bone scan).
    5.PSA value between ≥0.2 and ≤1.0 ng/ml measured at least six weeks postoperatively.
    6.The patients agree not to undergo testicular sperm extraction for at least 90 days after the last administration of pembrolizumab. (Due to prior surgical removal of the prostate no contraception is necessary.)
    7.Written informed consent obtained according to international guidelines and local law.
    8.Patients further having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
    9.Patients with adequate organ function as defined in Table 2.
    1.Männliche Patienten, zum Zeitpunkt der Einwilligung mindestens 18 Jahre alt.
    2.Histologisch bestätigte Diagnose eines Adenokarzinoms der Prostata und biochemisches Rezidiv (BCR) oder Persistenz des prostataspezifischen Antigens (PSA) nach radikaler Prostatektomie (RP).
    3.Histologie der bei der RP entnommenen Gewebeprobe: Adenokarzinom der Prostata, Gleason Score 7-10, pNX oder pN0 bzw. pN1 (maximal zwei Lymphknoten betroffen).
    4.Bildgebung 50 Tage vor Studieneinschluss (Registrierung des Patienten) (68Ga] oder [18F] PSMA PET-CT als Standardverfahren, alternativ CT des Abdomens sowie Skelettszintigraphie).
    5.Im Falle der PSA Persistenz muss der PSA Wert 6 Wochen postoperativ zwischen ≥0.2 and ≤1.0 ng/ml gelegen haben
    6.Einverständnis sich mind. 90 Tage nach der letzten Verabreichung von Pembrolizumab keiner Testikulären Spermienextraktion im Sinne einer operativen Intervention zur Spermienasservation zu unterziehen. (Aufgrund vorheriger Entfernung der Prostata ist keine reguläre Verhütung notwendig).
    7.Unterschriebene Einwilligungserklärung entsprechen den geltenden internationalen und lokalen Vorgaben bzw. Gesetzen.
    8.Performanzstatus gemäß Eastern Cooperative Oncology Group (ECOG) zwischen 0 und 1.
    9.Adäquate Organfunktionen des Patienten wie in Tabelle 2 (siehe Kapitel 4.2 in Studienprotokoll) beschrieben.
    E.4Principal exclusion criteria
    1.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., CTLA-4, OX 40, CD137).
    2.Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to registration (like neo-adjuvant androgen deprivation therapy (ADT), secondary hormone ablation or taxan-based chemotherapy).
    3.Prior radiotherapy within 4 weeks before start of study medication. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
    4.Distant metastases or suspicious lymph nodes outside the lower pelvis in imaging with PSMA PET-CT (patients with PET positive bone lesions that are morphologically not clearly suspicious of metastases and would not change clinical practice can be included).
    5.Adverse histology of RP specimen (e.g. neuroendocrine or small cell)
    6.Any vaccination with live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study medication. Administration of killed vaccine is allowed.
    7.Currently or previously participating in a study of an investigational product within 4 weeks prior to the first dose of study medication.
    8.Diagnosis of immunodeficiency, 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 medication.
    9.History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
    10.Known active CNS metastases and/or carcinomatous meningitis.
    11.Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
    12.Active autoimmune disease that required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
    13.History of (non-infectious) pneumonitis/intestinal lung disease that required steroids or currently pneumonitis/intestinal lung disease.
    14.Active infection requiring systemic therapy.
    15.History of Human Immunodeficiency Virus (HIV) infection.
    16.History of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. No testing is required.
    17.History of active TB (Bacillus Tuberculosis).
    18.History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.
    19.Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    20.History of allogeneic tissue/solid organ transplantation.
    1.Vorangegangene Therapie mit einem PD-L1 Inhibitor oder einer anderen Immuntherapie (z.B. PD-L2, CTLA-4, OX-40, CD137).
    2.Vorangegangene Krebstherapie bzgl. des Prostatakarzinoms mit medikamentöser Behandlung innerhalb von 4 Wochen vor Studieneinschluss (z.B. neoadjuvante Androgendeprivationstherapie, sekundäre Hormonablation oder Chemotherapie auf Taxanbasis).
    3.Vorangegangene Strahlenbehandlung innerhalb von 4 Wochen vor der ersten Verabreichung der Studienmedikation. Die Patienten sind außerdem genesen von möglichen strahlenbedingten Toxizitäten, bzw. werden nicht mit Kortikosteroiden behandelt und leiden nicht an einer akuten Strahlenpneumonitis.
    4.Verdacht auf Fernmetastasen oder verdächtige Lymphknoten außerhalb des kleinen Beckens in PSMA-PET-CT (Patienten mit PET positiven Lymphknoten im Becken oder Knochenschäden, die morphologisch nicht eindeutig verdächtig sind und die die klinische Praxis nicht verändern, dürfen eingeschlossen werden).
    5.Atypische Histologie der RP-Probe, beispielsweise kleinzellige Differenzierung.
    6.Impfung mit Lebendimpfstoff oder einem abgeschwächten Lebendimpfstoff innerhalb von 30 Tagen vor der ersten Verabreichung der Studienmedikation (Totimpfstoff ist erlaubt).
    7.Aktuelle oder vorangegangene Teilnahme an einer Studie, in der die Studienmedikation innerhalb von 4 Wochen vor der ersten Verabreichung der Studienmedikation in dieser Studie verabreicht wurde.
    8.Diagnose einer Immunschwäche bzw. dauerhafte Behandlung mit systemischer Steriodtherapie (Dosis über täglich 10 mg Prednisolon-Äquivalent) oder andere Form von Immunsuppressionstherapie innerhalb von 7 Tagen der ersten Verabreichung der Studienmedikation.
    9.Vorhergehende Krebserkrankung, außer wenn diese nicht bereits erfolgreich behandelt wurde und innerhalb der letzten 2 Jahre wieder aufgetreten ist.
    10.Bekannte aktive Metastasen und/oder karzinomatöse Meningitis.
    11.Bekannte Überempfindlichkeit (≥Grade 3) gegenüber der Studienmedikation Pembrolizumab und/oder seiner Hilfsstoffe.
    12.Aktive Autoimmunerkrankung mit systematischer Behandlung über die letzten 2 Jahre (z.B. mit krankheitsverändernden Stoffen, Kortikosteroiden oder immunsupprimierenden Arzneimitteln). Eine Ersatztherapie (z.B. Thyroxin, Insulin oder physiologische Kortikosteroidersatztherapie aufgrund Nebennieren- oder Hirnanhangdrüseninsuffizienz, etc.) ist keine systematische Behandlung, die als Ausschlusskriterium gewertet wird.
    13.Aktuelle oder vorangegangene Erkrankung an einer nicht infektiösen Pneumonitis, die mit Sterioden behandelt werden musste.
    14.Aktive Infektion mit systemischer Therapie.
    15.Vorangegangene Infektion mit dem Humane Immundefizienz-Virus (HIV).
    16.Vorangegangene Hepatitis B oder akute Heptatitis C Erkrankung. Eine entsprechende Testung ist zum Studieneinschluss nicht notwendig.
    17.Vorangegangene Erkrankung an einer Tuberkulose.
    18.Hinweise zu oder (vorangegangene) Kenntnis zum (körperlichen) Zustand des Patienten, (abnormalen) Laborwerten oder Therapien, welche die Ergebnisse der Studie, die dauerhafte Teilnahme des Patienten an der Studie beeinflussen könnten oder in Kombination mit der Studienteilnahme, aus Sicht des Prüfarztes, nicht im besten Interesse des Patienten sind.
    19.Bekannte psychiatrische Erkrankung oder Substanzabhängigkeiten, welche die dauerhafte Teilnahme des Patienten an der Studie gefährden könnten.
    20.Vorangegangene Transplantation (Organ- sowie Stammzelltransplantation).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is complete biochemical response (PSA level) 60 weeks after start of trial treatment, which further defines diagnosis of patients and the further course of disease.
    Der primäre Endpunkt ist komplettes biochemisches Ansprechen definiert als PSA Level unter der Nachweisgrenze in Woche 60 nach Start der Behandlung mit Pembrolizumab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 weeks after start of trial treatment
    60 Wochen nach Beginn der Behandlung
    E.5.2Secondary end point(s)
    Secondary efficacy endpoint is radiographic progression-free survival (rPFS) at week 60 after start of trial treatment.
    If patients present with persistent PSA, imaging is required and response assessment will be performed as described in section 7.5.15
    If PSA is below detection level, patients will be classified as progression free, imaging at W 60 is recommended but is not obligatory
    Der sekundäre Endpunkt ist das bildmorphologische progressionsfreie Überleben (rPFS) in Woche 60 nach Start der Behandlung mit Pembrolizumab, sofern eine PSA Persistenz vorliegt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 weeks after start of trial treatment
    60 Wochen nach Beginn der Behandlung
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months40
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state49
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
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