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JOURNAL ONKOLOGIE – STUDIE

A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Rekrutierend

NCT-Nummer:
NCT03193190

Studienbeginn:
Juli 2017

Letztes Update:
01.04.2021

Wirkstoff:
Nab-Paclitaxel, Oxaliplatin, Atezolizumab, Cobimetinib, PEGPH20, BL-8040, Selicrelumab, Bevacizumab, RO6874281, Gemcitabine, Leucovorin, Fluorouracil, AB928, Tiragolumab, Tocilizumab

Indikation (Clinical Trials):
Adenocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: WO39608 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 27)

Charite - Campus Virchow-Klinikum
13353 Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
45122 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
City of Hope Comprehensive Cancer Center
91010 Duarte
United StatesRekrutierend» Google-Maps
Helen Diller Fam Comp Can Ctr
94158 San Francisco
United StatesRekrutierend» Google-Maps
Smilow Cancer Hospital at Yale New Haven
06510 New Haven
United StatesRekrutierend» Google-Maps
Lombardi Cancer Center, Georgetown University
20007 Washington
United StatesRekrutierend» Google-Maps
Uni of Chicago Medical Center; Room M454
60637 Chicago
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesAbgeschlossen» Google-Maps
Beth Israel Deaconess Medical Center
02215 Boston
United StatesAbgeschlossen» Google-Maps
Dana-Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
Morristown Medical Center
07962 Morristown
United StatesRekrutierend» Google-Maps
Columbia University
10032-3725 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Oregon Health and Science University
97239 Portland
United StatesRekrutierend» Google-Maps
Hillman Cancer Center;Medical Oncology
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Sarah Cannon Cancer Center
38138 Germantown
United StatesAbgeschlossen» Google-Maps
Medical College of Wisconsin
53226 Milwaukee
United StatesRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Chiba
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Tokyo
JapanRekrutierend» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Clínica Universidad de Navarra
31620 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety,

tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based

treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma

(PDAC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who

have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of

patients who have received one line of prior systemic therapy for PDAC. In each cohort,

eligible patients will be assigned to one of several treatment arms.

Ein-/Ausschlusskriterien

Inclusion Criteria:

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

- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma

- For patients in Cohort 1: no prior systemic treatment for PDAC

- For patients in Cohort 2: disease progression during administration of either 5-FU- or

gemcitabine-based first-line chemotherapy

- Life expectancy greater than or equal to 3 months

- Availability of a representative tumor specimen that is suitable for determination of

programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central

testing

- Measurable disease (at least one target lesion) according to RECIST v1.1

- Adequate hematologic and end-organ function test results

- Tumor accessible for biopsy

- For women of childbearing potential: agreement to remain abstinent (refrain from

heterosexual intercourse) or use contraceptive measures, and agreement to refrain from

donating eggs, as outlined for each specific treatment arm

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use

contraceptive measures, and agreement to refrain from donating sperm, as outlined for

each specific treatment arm

Exclusion Criteria:

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage

procedure (i.e., more than one time per month)

- Symptomatic, untreated, or actively progressing central nervous system (CNS)

metastases

- History of leptomeningeal disease

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced

pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening

chest computed tomography (CT) scan

- Positive human immunodeficiency (HIV) test at screening or at any time prior to

screening

- Active hepatitis B or C virus infection or active tuberculosis

- Severe infection within 4 weeks prior to initiation of study treatment

- Prior allogeneic stem cell or solid organ transplantation

- History of malignancy other than pancreatic carcinoma within 2 years prior to

screening, with the exception of those with a negligible risk of metastasis or death

Studien-Rationale

Primary outcome:

1. Percentage of Participants With Objective Response, as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) (Time Frame - From randomization until disease progression or loss of clinical benefit (up to approximately 3-5 years))

2. Percentage of Participants With Adverse Events (AEs) (Time Frame - From first study treatment administration until 30 days after the last dose or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 3-5 years))

Secondary outcome:

1. Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1 (Time Frame - From randomization up to the first occurrence of disease (up to approximately 3-5 years))

2. Overall Survival (Time Frame - From randomization up to death from any cause (up to approximately 3-5 years))

3. Percentage of Participants who are Alive at Month 6 (Time Frame - Month 6)

4. Duration of Response, as Determined by Investigator According to RECIST v1.1 (Time Frame - From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years))

5. Percentage of Participants With Disease Control, as Determined by Investigator According to RECIST v1.1 (Time Frame - From randomization until disease progression or loss of clinical benefit (up to approximately 3-5 years))

Studien-Arme

  • Active Comparator: Cohort 1: Control (Nab-Paclitaxel and Gemcitabine)
    Cohort 1: Participants will receive Nab-Paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle. Participants in the Cohort 1 control arm who experience disease progression will be given the option of enrolling into Cohort 2 (if open for enrollment), provided they meet eligibility criteria.
  • Experimental: Cohort 1: Atezolizumab + Chemotherapy + Selicrelumab
    Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Selicrelumab 16 mg subcutaneous injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each 28-day cycle.
  • Experimental: Cohort 1: Atezolizumab + Chemotherapy + Bevacizumab
    Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Bevacizumab 10 mg/kg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
  • Experimental: Cohort 1: Atezolizumab + Chemotherapy + AB928
    Cohort 1: Participant will receive AB928 150 mg orally once daily on Days 1 to 28 of each 28 day cycle; Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
  • Experimental: Cohort 1: Atezolizumab + Chemotherapy + Tiragolumab
    Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Tiragolumab 420 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
  • Experimental: Cohort 2: Atezolizumab + Cobimetinib
    Cohort 2: Participants will receive Cobimetinib 60 milligrams (mg) once daily orally on Days 1-21 of each 28-day cycle; and Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28-day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arm is open for enrollment.
  • Experimental: Cohort 2: Atezolizumab + PEGPH20
    Cohort 2: Participants will receive PEGPH20 3 micrograms per kilogram (mcg/kg) IV infusion on Days 1, 8 and 15 of each 21-day cycle; and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
  • Experimental: Cohort 2: Atezolizumab + BL-8040
    Cohort 2: Participants will receive BL-8040 1.25 milligrams per kilogram (mg/kg) subcutaneously (SC) on Days 1-5 of the first week, followed by combination treatment consisting of BL-8040 1.25 mg/kg SC three times a week on non-consecutive days and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
  • Experimental: Cohort 2: Atezolizumab + RO6874281 every 2 weeks
    Cohort 2: Participants will receive Atezolizumab 840 mg IV infusion on days 1 and 15 of each 28 day cycle; RO6874281 will be administered 10 mg by IV infusion on day 1 and 15 mg on days 8, 15, and 22 for cycle 1 (28 day cycle). RO6874281 will be administered 15 mg by IV infusion on days 1 and 15 of each subsequent 28 day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment.
  • Experimental: Cohort 2: Atezolizumab + RO6874281 every 3 weeks
    Cohort 2: Participants will receive Atezolizumab 1200 mg IV infusion on Day 1 of each 21 day cycle; and RO6874281 10 mg by IV infusion on day 1 of each 21 day cycle. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment.
  • Active Comparator: Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)
    Cohort 2: Participants who progressed on a prior fluoropyrimidine-based regimen will receive Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle. Participants who progressed on a prior gemcitabine-based regimen will receive 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6). Participants will receive Oxaliplatin 85 mg/m^2 IV on Days 1 and 15 of each 28 day cycle; Leucovorin 400 mg/m^2 IV on Days 1 and 15 of each 28 day cycle; Fluorouracil 400 mg/m^2 IV push on Days 1 and 15 of each 28 day cycle; and Fluorouracil 2400 mg/m^2 IV continuous infusion over 46 hours on Days 1 and 2 and on Days 15 and 16 of each 28 day cycle. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
  • Experimental: Cohort 1: Atezolizumab + Chemotherapy + Tocilizumab
    Cohort 1: Participants will receive Tocilizumab 8 mg/kg IV infusion on Day 1 of each 28 day cycle; Atezolizumab 1680 mg IV infusion on Day 1 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.

Geprüfte Regime

  • Nab-Paclitaxel:
    Nab-Paclitaxel will be administered as per the schedule specified in the respective arm.
  • Gemcitabine:
    Gemcitabine will be administered as per the schedule specified in the respective arm.
  • Oxaliplatin:
    Oxaliplatin will be administered as per the schedule specified in the respective arm.
  • Leucovorin:
    Leucovorin will be administered as per the schedule specified in the respective arm.
  • Fluorouracil:
    Fluorouracil will be administered as per the schedule specified in the respective arm.
  • Atezolizumab:
    Atezolizumab will be administered as per the schedule specified in the respective arm.
  • Cobimetinib:
    Cobimetinib will be administered as per the schedule specified in the respective arm.
  • PEGPH20:
    PEGPH20 will be administered as per the schedule specified in the respective arm.
  • BL-8040:
    BL-8040 will be administered as per the schedule specified in the respective arm.
  • Selicrelumab:
    Selicrelumab will be administered as per the schedule specified in the respective arm.
  • Bevacizumab:
    Bevacizumab will be administered as per the schedule specified in the respective arm.
  • RO6874281:
    RO6874281 will be administered as per the schedule specified in the respective arm
  • AB928:
    AB928 will be administered as per the schedule specified in the respective arm.
  • Tiragolumab:
    Tiragolumab will be administered as per the schedule specified in the respective arm.
  • Tocilizumab:
    Tocilizumab will be administered as per the schedule specified in the respective arm.

Quelle: ClinicalTrials.gov


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