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JOURNAL ONKOLOGIE – STUDIE

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)

Rekrutierend

NCT-Nummer:
NCT04066491

Studienbeginn:
September 2019

Letztes Update:
01.02.2021

Wirkstoff:
Placebo, Gemcitabine, Cisplatin, Bintrafusp alfa

Indikation (Clinical Trials):
Cholangiocarcinoma, Biliary Tract Neoplasms, Gallbladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
EMD Serono Research & Development Institute, Inc.

Collaborator:
Merck KGaA, Darmstadt, Germany

Studienleiter

Medical Responsible
Study Director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Kontakt

Studienlocations
(3 von 115)

Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie
Bonn
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:

E-Mail: maria.gonzalez-carmona@ukbonn.de» Ansprechpartner anzeigen
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:

E-Mail: gunnar.folprecht@uniklinikum-dresden.de» Ansprechpartner anzeigen
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz
Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:

E-Mail: markus.moehler@unimedizin-mainz.de» Ansprechpartner anzeigen
University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion
66216 Westwood
United StatesRekrutierend» Google-Maps
Ansprechpartner:

E-Mail: wsun2@kumc.edu» Ansprechpartner anzeigen
University of Massachusetts Memorial Medical Center - Pediatrics
01605-2610 Worcester
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:

E-Mail: venu.bathini@umassmemorial.org» Ansprechpartner anzeigen
Fudan University Shanghai Cancer Center
Beijing
ChinaNoch nicht rekrutierend» Google-Maps
The Second Affiliated Hospital of Soochow University
Suzhou
ChinaNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria
Bologna
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:

E-Mail: giovanni.brandi@unibo.it» Ansprechpartner anzeigen
Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia
Napoli
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:

E-Mail: erika.martinelli@unicampania.it» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

Study consists of an open-label, safety run-in part and a randomized, double-blind,

placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study will evaluate whether

bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus

cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve

participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and

cisplatin.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Are participants with histologically or cytologically confirmed locally advanced or

metastatic BTC

- Participants must have available tumor tissue (primary or metastatic) (archival or

fresh biopsies) before the first administration of study treatment

- At least 1 measurable lesion according to RECIST 1.1

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study

entry and at Week 1, Day 1 prior to dosing

- Life expectancy of >= 12 weeks, as judged by the Investigator

- Adequate hematological function, hepatic function, renal function, coagulation

function as defined in the protocol

- Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be

treated and on a stable dose of antivirals

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Previous and/or intercurrent cancers

- Receipt of any organ transplantation, including allogeneic stem-cell transplantation,

but with the exception of transplants that do not require immunosuppression

- Participants with symptomatic central nervous system (CNS) metastases

- Significant acute or chronic infection including known history of positive test for

human immunodeficiency virus (HIV), active tuberculosis, uncontrolled biliary

infection and active bacterial or fungal infection requiring systemic therapy (with

the exception of hepatitis B and hepatitis C) requiring systemic therapy at study

entry and at Week 1 Day 1 prior to dosing.

- Active autoimmune disease that might deteriorate when receiving an immunostimulatory

agent

- History of or concurrent interstitial lung disease

- History of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent

(within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness

requiring hospitalization or precluding study therapy within 30 days before

randomization

- Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune

checkpoints)

- Other protocol defined exclusion criteria could apply

Studien-Rationale

Primary outcome:

1. Safety Run-in Part: Number of Participants with Dose-Limiting Toxicities (DLTs) During the DLT Evaluation Period (Time Frame - Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days))

2. Double-blinded Part: Overall Survival (OS) (Time Frame - First dose of study intervention up to 4 years)

Secondary outcome:

1. Safety Run-in Part: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (Time Frame - First dose of study intervention up to 4 years)

2. Safety Run-in Part: Number of Participants with Abnormalities (Grade >= 3) in Laboratory Tests (Time Frame - First dose of study intervention up to 4 years)

3. Double-blinded: Confirmed Objective Response (COR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Assessed by Investigator (Time Frame - First dose of study intervention up to 4 years)

4. Double-blinded Part: Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator or Death (Time Frame - Time from CR or PR up to 4 years)

5. Double-blinded Part: Durable Response of at Least 6 Months According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator (Time Frame - First dose of study intervention up to 4 years)

6. Double-blinded Part: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment Related Adverse Events and Adverse Events of Special Interest (AESI) (Time Frame - First dose of study intervention up to 4 years)

7. Double-blinded Part: Serum Concentration Observed Immediately at the End of Infusion (Ceoi) of Bintrafusp alfa (Time Frame - Pre-dose, 30 minutes post-dose at Week 1 Day 1, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years)

8. Double-blinded Part: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Bintrafusp alfa (Time Frame - Pre-dose, 30 minutes post-dose at Week 1 Day 1, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years)

9. Safety Run-in Part: Area Under Serum Concentration-Time Curve (AUC0-t) From Time Zero to The Last Sampling Time of Bintrafusp alfa (Time Frame - Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years)

10. Safety Run-in Part: Area Under Serum Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp alfa (Time Frame - Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years)

11. Safety Run-in Part: Maximum Observed Serum Concentration (Cmax) of Bintrafusp alfa (Time Frame - Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years)

12. Safety Run-in Part: Time to Reach Maximum Observed Serum Concentration (Tmax) of Bintrafusp alfa (Time Frame - Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years)

13. Safety Run-in Part: Apparent Terminal Half-Life (t1/2) of Bintrafusp alfa (Time Frame - Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years)

14. Double-blinded Part: Immunogenicity as measured by Anti-drug Antibodies Concentration (Time Frame - Pre-dose, 30 minutes post-dose at Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years)

15. Double-blinded Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Assessed by Investigator (Time Frame - First dose of study intervention up to 4 years)

Studien-Arme

  • Experimental: Safety Run-In Part: Bintrafusp alfa + Gemcitabine + Cisplatin
  • Experimental: Double-blinded Part: Bintrafusp alfa + Gemcitabine + Cisplatin
  • Placebo Comparator: Double-blinded Part: Placebo + Gemcitabine + Cisplatin

Geprüfte Regime

  • Bintrafusp alfa (M7824):
    Participants will receive Bintrafusp alfa intravenously at a dose of 2400 milligram (mg) once every 3 weeks (Q3W) until confirmed disease progression, death, unacceptable toxicity, study withdrawal or for 2 years after the first onset of Complete Response (CR).
  • Placebo:
    Participants will receive Bintrafusp alfa matched Placebo intravenously once every 3 weeks (Q3W) until confirmed disease progression, death, unacceptable toxicity, study withdrawal or for 2 years after the first onset of CR.
  • Gemcitabine:
    Gemcitabine will be received intravenously at a dose of 1000 milligram per meter square (mg/m^2) on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks (Q3W).
  • Cisplatin:
    Cisplatin will be received intravenously at a dose of 25 mg/m^2 on Day 1 and Day 8 of 21-day cycle, for 8 cycles every 3 weeks (Q3W).

Quelle: ClinicalTrials.gov


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