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JOURNAL ONKOLOGIE – STUDIE

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Rekrutierend

NCT-Nummer:
NCT03711032

Studienbeginn:
Dezember 2018

Letztes Update:
08.08.2024

Wirkstoff:
Pembrolizumab, BCG

Indikation (Clinical Trials):
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Merck Sharp & Dohme LLC

Collaborator:
-

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme LLC

Kontakt

Studienlocations
(3 von 207)

Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)
54292 Trier
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +496512082680
» Ansprechpartner anzeigen
Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)
99503 Anchorage
United StatesAbgeschlossen» Google-Maps
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
90095 Los Angeles
United StatesAbgeschlossen» Google-Maps
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)
33136 Miami
United StatesAktiv, nicht rekrutierend» Google-Maps
Woodlands Medical Specialists, PA ( Site 8002)
32503 Pensacola
United StatesAbgeschlossen» Google-Maps
Wichita Urology Group ( Site 1086)
67226 Wichita
United StatesAktiv, nicht rekrutierend» Google-Maps
Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)
71106 Shreveport
United StatesAbgeschlossen» Google-Maps
Coastal Urology Associates ( Site 1055)
08724 Brick
United StatesAbgeschlossen» Google-Maps
Rutgers Cancer Institute of New Jersey ( Site 1059)
08903 New Brunswick
United StatesAktiv, nicht rekrutierend» Google-Maps
St. Peter's Hospital Cancer Care Center ( Site 1087)
12208 Albany
United StatesAbgeschlossen» Google-Maps
Associated Medical Professionals of NY ( Site 1078)
13210 Syracuse
United StatesAbgeschlossen» Google-Maps
University Hospitals Cleveland Medical Center ( Site 1066)
44106 Cleveland
United StatesAbgeschlossen» Google-Maps
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10
43210 Columbus
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 614-366-7421
» Ansprechpartner anzeigen
OHSU Knight Cancer Institute ( Site 1075)
97210 Portland
United StatesAbgeschlossen» Google-Maps
Texas Oncology-Fort Worth Cancer Center ( Site 8003)
76104 Fort Worth
United StatesAbgeschlossen» Google-Maps
Texas Oncology-Plano West ( Site 8001)
75093 Plano
United StatesAbgeschlossen» Google-Maps
Northern Cancer Institute. ( Site 0003)
2065 St Leonards
AustraliaAbgeschlossen» Google-Maps
Sydney Adventist Hospital ( Site 0001)
2076 Wahroonga
AustraliaAbgeschlossen» Google-Maps
Univ. Klinik f. Urologie Innsbruck ( Site 0051)
6020 Innsbruck
AustriaAbgeschlossen» Google-Maps
Hospital São Carlos-Oncocentro Ce ( Site 1558)
60135-237 Fortaleza
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)
81520060 Curitiba
BrazilAktiv, nicht rekrutierend» Google-Maps
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)
14784-400 Barretos
BrazilAktiv, nicht rekrutierend» Google-Maps
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)
01246-000 Sao Paulo
BrazilAbgeschlossen» Google-Maps
BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)
01321-001 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)
04014-002 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Exdeo Clinical Research Inc. ( Site 0165)
V2T 1X8 Abbotsford
CanadaAktiv, nicht rekrutierend» Google-Maps
Silverado Resarch Inc. ( Site 0155)
V8T 2C1 Victoria
CanadaAbgeschlossen» Google-Maps
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
G1J 1Z4 Quebec
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 418525444420414
» Ansprechpartner anzeigen
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
210000 NanJing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8602583106666
» Ansprechpartner anzeigen
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)
325000 Wenzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 0577-55579590
» Ansprechpartner anzeigen
Instituto de Cancerología-Oncology ( Site 1609)
050024 Medellín
ColombiaAktiv, nicht rekrutierend» Google-Maps
Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad
054047 Rionegro
ColombiaAktiv, nicht rekrutierend» Google-Maps
Oncomedica S.A.-Oncomedica S.A ( Site 1604)
230002 Montería
ColombiaAktiv, nicht rekrutierend» Google-Maps
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)
111321 Bogota
ColombiaAktiv, nicht rekrutierend» Google-Maps
Administradora Country S.A. - Clinica del Country ( Site 1607)
110221 Bogotá
ColombiaAktiv, nicht rekrutierend» Google-Maps
Oncologos del Occidente ( Site 1608)
661001 Pereira
ColombiaAktiv, nicht rekrutierend» Google-Maps
Hemato Oncologos SA-Oncology ( Site 1601)
76001 Cali
ColombiaAbgeschlossen» Google-Maps
Clínica Imbanaco S.A.S ( Site 1611)
760042 Cali
ColombiaAktiv, nicht rekrutierend» Google-Maps
CIMCA ( Site 1550)
10103 San José
Costa RicaAktiv, nicht rekrutierend» Google-Maps
Policlinico San Bosco ( Site 0600)
10103 San Jose
Costa RicaAktiv, nicht rekrutierend» Google-Maps
Tampere University Hospital [Tampere Finland] ( Site 0201)
33520 Tampere
FinlandAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)
21000 Dijon
FranceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 33380293761
» Ansprechpartner anzeigen
Olympion General Clinic ( Site 0306)
264 43 Patras
GreeceAbgeschlossen» Google-Maps
General University Hospital of Patras ( Site 0302)
265 04 Patra
GreeceAbgeschlossen» Google-Maps
Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)
54007 Thessaloniki
GreeceAbgeschlossen» Google-Maps
Onco Go, S.A ( Site 1454)
01010 Guatemala City
GuatemalaAktiv, nicht rekrutierend» Google-Maps
INTEGRA Cancer Institute ( Site 1451)
01010 Guatemala
GuatemalaAktiv, nicht rekrutierend» Google-Maps
Grupo Medico Angeles ( Site 1453)
01015 Guatemala
GuatemalaAktiv, nicht rekrutierend» Google-Maps
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)
6725 Szeged
HungaryRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +36709411312
» Ansprechpartner anzeigen
Istituto Tumori Giovanni Paolo II ( Site 0357)
70124 Bari
ItalyAbgeschlossen» Google-Maps
Ospedale San Martino ( Site 0351)
16132 Genova
ItalyAbgeschlossen» Google-Maps
Asan Medical Center ( Site 0804)
05505 Songpagu
Korea, Republic ofAbgeschlossen» Google-Maps
Samsung Medical Center ( Site 0803)
06351 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
University Malaya Medical Centre ( Site 1180)
59100 Kuala Lumpur
MalaysiaAbgeschlossen» Google-Maps
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)
3584 CX Utrecht
NetherlandsAbgeschlossen» Google-Maps
Akershus University Hospital ( Site 0553)
1478 Lorenskog
NorwayAktiv, nicht rekrutierend» Google-Maps
Stavanger universitetssykehus ( Site 0555)
4011 Stavanger
NorwayAktiv, nicht rekrutierend» Google-Maps
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)
15033 La Victoria
PeruAbgeschlossen» Google-Maps
Pratia MCM Krakow ( Site 0668)
30-510 Krakow
PolandAbgeschlossen» Google-Maps
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
08-110 Siedlce
PolandAbgeschlossen» Google-Maps
Luxmed Onkologia sp. z o. o. ( Site 0653)
01-748 Warszawa
PolandAbgeschlossen» Google-Maps
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)
83-400 Koscierzyna
PolandAbgeschlossen» Google-Maps
2CA Braga. Centro Clinico Academico ( Site 0705)
4710-243 Braga
PortugalAktiv, nicht rekrutierend» Google-Maps
Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)
3000-075 Coimbra
PortugalAbgeschlossen» Google-Maps
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)
1099-023 Lisboa
PortugalAbgeschlossen» Google-Maps
CHLN Hospital Santa Maria ( Site 0702)
1649-035 Lisboa
PortugalAktiv, nicht rekrutierend» Google-Maps
Hospital CUF Descobertas ( Site 0706)
1998-018 Lisboa
PortugalAbgeschlossen» Google-Maps
Advance Urology and Laparoscopic Center ( Site 0757)
00716 Ponce
Puerto RicoAktiv, nicht rekrutierend» Google-Maps
Ad-Vance Medical Research ( Site 0756)
00717 Ponce
Puerto RicoAktiv, nicht rekrutierend» Google-Maps
Clinica Universitaria de Navarra ( Site 0863)
31008 Pamplona
SpainAbgeschlossen» Google-Maps
Clinica Universitaria Navarra - Madrid ( Site 0860)
28027 Madrid
SpainAbgeschlossen» Google-Maps
China Medical University Hospital-Department of Urology ( Site 1654)
40447 Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taichung Veterans General Hospital ( Site 1653)
407 Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taipei Veterans General Hospital ( Site 1652)
112 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)
34722 Istanbul
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905323430723
» Ansprechpartner anzeigen
Dokuz Eylul Universitesi ( Site 0959)
35340 Izmir
TurkeyAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

Researchers are looking for new ways to treat high-risk non muscle invasive bladder

cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but

has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may

have a high chance of getting worse or coming back after treatment.

The goals of this study are to learn: 1. If more people who receive pembrolizumab with

Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer

without the cancer growing, spreading, or coming back compared to people who receive BCG

alone. 2. About the safety and how well people tolerate BCG alone or in combination with

pembrolizumab.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Have locally and blinded independent central review (BICR)-confirmed histological

diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the

bladder

- Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove

all resectable disease

- Has provided tissue for biomarker analysis

- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

- Has adequate organ function

- During the treatment period and for ≥7 days after the last dose of BCG, male

participants are EITHER abstinent from heterosexual intercourse as their preferred

and usual lifestyle and agree to remain abstinent, OR, must agree to use

contraception unless confirmed to be azoospermic

- Female participants who are not pregnant, not breastfeeding, and either not a woman

of child bearing potential (WOCBP); or are a WOCBP who agrees to use a contraception

method that is highly effective or remains abstinent from heterosexual intercourse

during the treatment period and for ≥7 days after the last dose of BCG or 120 days

after the last dose of pembrolizumab, whichever comes last

BCG Post-induction Cohort (Cohort A) Only

- Has been treated with one adequate course of BCG induction therapy for the treatment

of HR NMIBC

- Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC

Exclusion Criteria:

- Has a history of or concurrent locally advanced (i.e., T2, T3, T4) or metastatic UC

- Has concurrent extra-vesical (i.e, urethra, ureter, renal pelvis) non-muscle

invasive urothelial carcinoma or a history of extra-vesical non-muscle invasive UC

- Has received prior therapy with 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

- Has received prior systemic anti-cancer therapy including investigational agents

within 4 weeks of start of study treatment

- Is currently participating in or has participated in a study of an investigational

agent or has used an investigational device within 4 weeks of start of study

treatment

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

or any other form of immunosuppressive therapy within 7 days of start of study

treatment

- Has a known additional malignancy that is progressing or requires active treatment

within the past 3 years

- Has an active autoimmune disease that has required systemic treatment in past 2

years

- Has a history of (non-infectious) pneumonitis/interstitial lung disease that

required steroids or has current pneumonitis/interstitial lung disease

- Has one or more of the following contraindications to BCG: prior BCG sepsis or

systemic infection, total bladder incontinence, or an adverse experience to a

previous BCG instillation that resulted in treatment discontinuation and precludes

retreating with BCG

- Has an active infection or diagnosis requiring systemic antimicrobial therapy

- Has a known history of human immunodeficiency virus (HIV) infection

- Has a known history of Hepatitis B or known active Hepatitis C virus infection

- Has current active tuberculosis

- Has had an allogenic-tissue/solid organ transplant

- Has any contraindication(s) to IV contrast or is otherwise unable to have screening

imaging with IV contrast performed

BCG Post-induction Cohort (Cohort A) Only - Has persistent T1 disease following an

induction course of BCG

BCG Naïve Cohort (Cohort B) Only

- Has received any prior treatment with BCG for their NMIBC within the past 2 years

prior to study entry

Studien-Rationale

Primary outcome:

1. Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A) (Time Frame - Up to ~3.5 years):
CRR is defined as the percentage of participants with CIS achieving a complete response (CR).

2. Event-Free Survival (EFS) (Cohort B) (Time Frame - Up to ~5 years):
EFS is defined as the time from randomization until urothelial carcinoma (UC)-defined event, or death due to any cause.

Secondary outcome:

1. EFS (Cohort A) (Time Frame - Up to ~5 years):
EFS is defined as the time from randomization until UC-defined event, or death due to any cause.

2. Recurrence-Free Survival (RFS) (Cohorts A and B) (Time Frame - Up to ~5 years):
RFS is defined as the time from randomization until the first occurrence of any UC recurrence, progression, or death due to any cause.

3. Overall Survival (OS) (Cohorts A and B) (Time Frame - Up to ~5 years):
OS is defined as the time from randomization to death due to any cause.

4. Disease Specific Survival (DSS) (Cohorts A and B) (Time Frame - Up to ~5 years):
DSS is defined as the time from randomization to death due to bladder cancer.

5. Time to Cystectomy (Cohorts A and B) (Time Frame - Up to ~5 years):
Time to cystectomy is defined as the time from a participant's randomization until the date of cystectomy.

6. 12-Month EFS Rate (Cohort A) (Time Frame - 12 months after EFS (up to ~5 years)):
EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 12-month EFS rate is defined as the percentage of participants with EFS at 12 months.

7. Duration of Response (DOR) (Cohorts A and B) (Time Frame - Up to ~5 years):
DOR is defined as the time from first documented CR until end of response or death due to any cause, whichever occurs first.

8. 12-Month DOR Rate (Cohorts A and B) (Time Frame - 12 months after CR (up to ~4.5 years)):
The 12-month DOR Rate is defined as the percentage of participants with a CR of at least 12 months duration.

9. Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B) (Time Frame - Up to ~5 years):
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.

10. Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B) (Time Frame - Up to ~5 years):
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.

11. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B) (Time Frame - Baseline, time of last PRO assessment (up to ~2 years)):
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.

12. Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B) (Time Frame - Baseline, time of last PRO assessment (up to ~2 years)):
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.

13. Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B) (Time Frame - Baseline, time of last PRO assessment (up to ~2 years)):
The EORTC-QLQ-NMIBC24 is a 24-item questionnaire developed to supplement the EORTC QLQ-C30 in high-risk NMIBC patients. Each item is scored out of 4 total points (1=Not at All to 4=Very Much). All responses are transformed from 0 to 100, with a high score indicating more symptoms or problems. The change from baseline in EORTC-QLQ-NMIBC24 total score will be presented.

14. Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (Cohorts A and B) (Time Frame - Baseline, time of last PRO assessment (up to ~2 years)):
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.

15. Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B) (Time Frame - Time of last PRO assessment (up to ~2 years)):
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD in Global Health Status/Quality of Life is defined as the time from baseline to the first onset of a 10 point or greater decrease from baseline in the Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score, with or without subsequent confirmation.

16. TTD in the EQ-5D-5L VAS (Cohorts A and B) (Time Frame - Time of last PRO assessment (up to ~2 years)):
The EQ-5D-5L VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD in EQ-5D-5L VAS is defined as the time from baseline to the first onset of a 7 point or greater decrease from baseline in EQ-5D-5L VAS, with or without subsequent confirmation, under a right-censoring rule.

17. CRR by BICR (Cohort B) (Time Frame - Up to ~3.5 years):
CRR is defined as the percentage of participants with CIS achieving a CR.

18. 24-Month EFS Rate (Cohort B) (Time Frame - 24 months after EFS (Up to ~5 years)):
EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 24-month EFS rate is defined as the percentage of participants with EFS at 24 months.

Studien-Arme

  • Experimental: BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)
    Participants receive BCG (Induction and Maintenance) in combination with 200 mg pembrolizumab administered intravenously (IV) every 3 weeks (Q3W) for 35 doses (~2 years).
  • Experimental: BCG Monotherapy: Post-induction Cohort A (Arm A-2)
    Participants receive BCG monotherapy (Induction and Maintenance).
  • Experimental: BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)
    Participants receive BCG (Induction and reduced Maintenance) in combination with 400 mg pembrolizumab administered IV every 6 weeks (Q6W) for 9 doses (~1 year).
  • Experimental: BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)
    Participants receive BCG (Induction and full Maintenance) in combination with 400 mg pembrolizumab administered IV Q6W for 9 doses (~1 year).
  • Experimental: BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)
    Participants receive BCG monotherapy (Induction and Maintenance).

Geprüfte Regime

  • Pembrolizumab (KEYTRUDA® / MK-3475 / ):
    Pembrolizumab IV infusion of 200 mg Q3W for BCG Post-Induction Cohort (Cohort A), or IV infusion of 400 mg Q6W for BCG Naïve Cohort (Cohort B), according to randomization
  • BCG (TICE® BCG / OncoTICE® / ):
    BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)"

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