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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

Rekrutierend

NCT-Nummer:
NCT03281369

Studienbeginn:
Oktober 2017

Letztes Update:
04.03.2021

Wirkstoff:
5-Fluorouracil (5-FU), Oxaliplatin, Cobimetinib, BL-8040, Linagliptin, Leucovorin, Paclitaxel, Atezolizumab, Ramucirumab, PEGylated recombinant human hyaluronidase (PEGPH20), Cisplatin, Tiragolumab

Indikation (Clinical Trials):
Adenocarcinoma, Esophageal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Hoffmann-La Roche

Collaborator:
Halozyme Therapeutics, BioLineRx, Ltd.,

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: YO39609 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 39)

Universitaetsklinikum Essen; Westdeutsches Tumorzentrum; Innere Klinik (Tumorforschung)
45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
60488 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
69120 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Mayo Clinic Cancer Center
85259 Scottsdale
United StatesAbgeschlossen» Google-Maps
Uni of Southern California; Norris Comprehensive Cancer Ctr
90033 Los Angeles
United StatesRekrutierend» Google-Maps
UCLA Jonsson Comprehensive Cancer Center
90095 Los Angeles
United StatesRekrutierend» Google-Maps
University of Kentucky
40536 Lexington
United StatesRekrutierend» Google-Maps
Dana-Farber Cancer Institute - Gastrointestinal Cancer Treatment Center
02111 Boston
United StatesZurückgezogen» Google-Maps
Mayo Clinic - Rochester; Breast Cancer Center
55905 Rochester
United StatesAbgeschlossen» Google-Maps
Columbia University Medical Center
10027 New York
United StatesAbgeschlossen» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
The University of Texas MD Anderson Cancer Center
77030-4009 Houston
United StatesRekrutierend» Google-Maps
Blacktown Hospital
2148 Blacktown
AustraliaNoch nicht rekrutierend» Google-Maps
Monash Medical Centre-Moorabbin Campus
3168 Clayton
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre; Medical Oncology
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Gustave Roussy Cancer Campus
94805 Villejuif
FranceZurückgezogen» Google-Maps
Rambam Health Care Campus; Oncology
3109601 Haifa
IsraelRekrutierend» Google-Maps
Hadassah University Medical Center
Jerusalem
IsraelRekrutierend» Google-Maps
Rabin MC; Davidof Center - Oncology Institute
4941492 Petach Tikva
IsraelRekrutierend» Google-Maps
Yonsei University College of Medicine (YUCM)-Yonsei Cancer Center; Cancer Metastasis Research Center
03722 Seodaemun-Gu
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofAbgeschlossen» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital (SNUH) - Medical Oncology Center
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
05505 Songpa-gu
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea St. Vincent's Hospital
442-723 Suwon-si,
Korea, Republic ofRekrutierend» Google-Maps
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
1066 CX Amsterdam
NetherlandsZurückgezogen» Google-Maps
Universidad de Navarra - Clinica Universitaria de Navarra (CUN)
31008 Pamplona
SpainAbgeschlossen» Google-Maps
Hospital Universitari Vall dHebron; Oncology
08035 Barcelona
SpainAbgeschlossen» Google-Maps
National Cheng Kung University Hospital
70457 Tainan
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital
11217 Taipei City
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital (NTUH) - Cancer Research Center
10051 Zhongzheng Dist.
TaiwanRekrutierend» Google-Maps
Beatson West of Scotland Cancer Centre
G12 0YN Glasgow
United KingdomRekrutierend» Google-Maps
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM
London
United KingdomNoch nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

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

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

treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ

cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of

patients with gastric cancer have been enrolled in parallel in this study: the second-line

(2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after

receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the

first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with

gastric cancer who have not received prior chemotherapy in this setting. In each cohort,

eligible patients will be assigned to one of several treatment arms. Additionally, a cohort

of patients with esophageal cancer who have not received prior systemic treatment for their

disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy

or the combination of chemotherapy with checkpoint inhibitor immunotherapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Gastric Cancer Cohorts Inclusion Criteria:

- Age >/= 18 years;

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

- Life expectancy >/= 3 months, as determined by the investigator;

- Histologically or cytologically confirmed locally advanced unresectable or metastatic

adenocarcinoma of gastric or gastroesophageal junction; (for the 1L Gastric Cancer

Cohort: no prior systemic therapy for the locally advanced or metastatic disease; for

the 2L Gastric Cancer Cohort: disease progression during or following a first-line

platinum-containing or fluoropyrimidine-containing chemotherapy regimen);

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

PD-L1 and TIGIT levels by IHC and/or additional biomarker status by means of

retrospective central testing;

- Only for the 1L Gastric Cancer Cohort: human epidermal growth factor receptor 2

(HER2)-negative tumors;

- Measurable disease (at least one target lesion) according to Response Evaluation

Criteria in Solid Tumors, Version 1.1 (RECIST v1.1);

- Adequate hematologic and end organ function based on laboratory results obtained

within 14 days prior to initiation of study treatment;

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

heterosexual intercourse) or use contraceptive measures 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.

Esophageal Cancer Cohort Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma or

adenocarcinoma of the esophagus in locally advanced or metastatic disease;

- No prior systemic treatment for esophageal cancer, with the following exception:

For patients treated with chemotherapy in the locally advanced setting: occurrence of

metastasis after 6 months from the last dose of chemotherapy;

- For patients with adenocarcinoma: absence of HER2 expression;

- Life expectancy >/=3 months as determined by the investigator;

- Measurable disease per RECIST v1.1;

- Adequate hematologic and end-organ function;

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

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

donating eggs;

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

contraceptive measures, and agreement to refrain from donating sperm;

- ECOG Performance Status of 0, 1, or 2.

Exclusion Criteria:

Exclusion criteria for the 2L Gastric Cancer Cohort:

- Urinary protein is > 1 + on dipstick and the required following 24-hour urine

collection shows urinary protein > 2000 mg;

- Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to

initiation of study treatment;

- History of gastrointestinal perforation and/or fistulae within 6 months prior to

initiation of study treatment;

- Presence of a bowel obstruction, history or presence of inflammatory enteropathy, or

extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic

diarrhea;

- Uncontrolled arterial hypertension >/= 150/ >/= 90 millimeter of mercury (mmHg)

despite standard medical management;

- Chronic therapy with non-steroidal anti-inflammatory agents or other anti-platelet

agents.

Gastric Cancer Exclusion Criteria:

- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of

bisphosphonate therapy;

- 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 (e.g., bronchiolitis

obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of

active pneumonitis on screening chest computed tomography (CT) scan;

- Positive test for human immunodeficiency virus (HIV) at screening;

- Active hepatitis B virus (HBV) or hepatitis C (HCV) infection;

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

- Significant cardiovascular disease;

- Significant bleeding disorder;

- Prior allogeneic stem cell or solid organ transplantation;

- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation

of study treatment, or anticipation of need for a major surgical procedure during the

study;

- Treatment with anticoagulation with warfarin, low-molecular-weight heparin, or similar

agents for therapeutic purposes;

- History of malignancy other than gastric or gastroesophageal junction carcinoma within

2 years prior to screening, with the exception of those with a negligible risk of

metastasis or death;

- Known allergy or hypersensitivity to any of the study drugs or their excipients.

Esophageal Cancer Cohort Exclusion Criteria:

- High risk for developing esophageal fistula by clinical assessment or imaging;

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

Metastases;

- Active EBV infection and known or suspected chronic active EBV infection at screening;

- 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;

- Active tuberculosis;

- Significant cardiovascular disease within 3 months prior to initiation of study

treatment, unstable arrhythmia, or unstable angina;

- History of malignancy other than esophageal cancer within 2 years prior to screening,

with the exception of malignancies with a negligible risk of metastasis or death;

- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment

or within 5 months after the final dose of atezolizumab and 5 months after the final

dose of tiragolumab.

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 3-6 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 3-6 years))

3. For Arm 1L-A : Percentage of Participants with Serious and Non-serious Treatment-related AEs (Time Frame - During the safety run-in phase up to 28 days)

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 3-6 years))

2. Overall Survival (OS) (Time Frame - From randomization up to death from any cause (up to approximately 3-6 years))

3. Percentage of Participants Who Are Alive at Month 6 and at Month 12 (Time Frame - Month 6, Month 12)

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 3-6 years))

5. Percentage of Participants With Disease Control, as Determined by the Investigator per RECIST v1.1 (Time Frame - From randomization until disease progression or loss of clinical benefit (up to approximately 3-6 years))

6. Serum Concentration of Atezolizumab (Time Frame - Pre-infusion (0 hour [hr]), 30 minutes (min) post-infusion (infusion=60 min) on Day 1 of Cycle 1; pre-infusion (0 hr) on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (each cycle=28 days); 30 days and 120 days after last dose (up to approximately 3-6 years))

7. Plasma Concentration of Cobimetinib (Time Frame - Prior to cobimetinib dose, 2-4 hr after cobimetinib dose on Day 15 of Cycle 1 (cycle length=28 days))

8. Plasma Concentration of PEGPH20 (Time Frame - Pre-infusion (0 hr) on Day 1 of Cycle 1 up to 30 days and 120 days after last dose (up to approximately 3-6 years) (Detailed timeframe is provided in outcome measure description)):
Pre-infusion (0 hr), 5 min and 1-3 hrs post infusion (infusion duration=10-12 min) on Day 1 of Cycle 1; pre-infusion (0 hr) on Days 8 and 15 of Cycle 1, Day 1 of Cycles 3, 4, 8, 12, 16; pre-infusion (0 hr) and 5 min post-infusion on Day 1 of Cycle 2 (each cycle=21 days); 30 days and 120 days after last dose (up to approximately 3-6 years)

9. Plasma Concentration of BL-8040 (Time Frame - Pre-dose (0 hr) on Day 1 of priming period (1 week prior to Day 1 of Cycle 1) up to 30 days after last dose (up to approximately 3-6 years) (Detailed timeframe is provided in outcome measure description)):
Pre-dose (0 hr) on Day 1 of priming period (1 week prior to Day 1 of Cycle 1); 1 hr post-dose on Days 1, 5 of priming period; pre-dose (0 hr), 1 hour post-dose on Day 15 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 8, 12, 16; pre-dose (0 hr) on Day 1 of Cycle 20 and every 4 cycles thereafter (each cycle=21 days) (up to approximately 3-6 years); 30 days after last dose (up to approximately 3-6 years)

10. Plasma Concentration of Linagliptin (Time Frame - 2 hr postdose oral linagliptin on Day 1 of Cycle 1, prior to atezolizumab infusion and predose oral linagliptin on Day 15 of Cycle 1 as well as on Day 1 of Cycles 2, 3, and 4)

11. Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab (Time Frame - Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 (each cycle=28 days); 30 days and 120 days after last dose (up to approximately 3-6 years))

12. Percentage of Participants With ADA to PEGPH20 (Time Frame - Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 (each cycle=21 days); 30 days and 120 days after last dose (up to approximately 3-6 years))

13. Percentage of Participants With ADA to BL-8040 (Time Frame - Pre-dose (0 hr) on Day 1 of priming period (1 week prior to Day 1 of Cycle 1) up to 30 days after last dose (up to approximately 3-6 years) (Detailed timeframe is provided in outcome measure description)):
Pre-dose (0 hr) on Day 1 of priming period (1 week prior to Cycle 1 Day 1), Day 15 of Cycle 1 and Day 1 of Cycles 2, 3, 4, 8, 12, 16, 20 and every 4 cycles thereafter (each cycle=21 days) (up to approximately 3-6 years); 30 days after last dose (up to approximately 3-6 years)

14. Percentage of Participants With Objective Response, in Participants with TIGIT-Positive Tumors by IHC (Esophageal Cancer Cohort Only) (Time Frame - From Randomization until disease progression or loss of clinical benefit (up to approximately 2 years))

15. Percentage of Participants With Objective Response, in Participants With PD-L1 IC/TC-Positive Tumors by IHC (Esophageal Cancer Cohort Only) (Time Frame - From Randomization until disease progression or loss of clinical benefit (up to approximately 2 years))

Studien-Arme

  • Active Comparator: 1L-Control: mFOLFOX6 (Gastric Cancer)
    Participants in the 1L Gastric Cancer Control arm will receive modified FOLFOX6 (mFOLFOX6) treatment consisting of 5-fluorouracil (5-FU), leucovorin (folinic acid), and oxaliplatin. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib treatment, provided they meet the eligibility criteria. No longer enrolling participants as of June 2018.
  • Experimental: 1L-A: mFOLFOX6 + Atezo + Cobi (Gastric Cancer)
    Participants in the 1L-A Gastric Cancer arm will receive mFOLFOX6 treatment consisting of 5-FU, leucovorin and oxaliplatin in combination with atezolizumab plus cobimetinib. No longer enrolling participants as of June 2018.
  • Experimental: 1L-A2: Atezo+mFOLFOX6 followed by Atezo+Cobi (Gastric Cancer)
    Participants in the 1L-A2 Gastric Cancer arm will receive mFOLFOX6 treatment consisting of 5-FU, leucovorin and oxaliplatin in combination with atezolizumab during cycles 1 and 2 followed by atezolizumab plus cobimetinib during cycles 3 and beyond. No longer enrolling participants as of June 2018.
  • Experimental: 1L-B: mFOLFOX6 + Atezo (Gastric Cancer)
    Participants in the 1L-B Gastric Cancer arm will receive mFOLFOX6 treatment consisting of 5-FU, leucovorin and oxaliplatin in combination with atezolizumab. Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib treatment, provided they meet the eligibility criteria. No longer enrolling participants as of June 2018.
  • Active Comparator: 2L-Control: Ramucirumab + Paclitaxel (Gastric Cancer)
    Participants in the 2L Gastric Cancer Control arm received ramucirumab plus paclitaxel. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019.
  • Experimental: 2L-1: Atezo + Cobi (Gastric Cancer)
    Participants in the 2L-1 Gastric Cancer arm received atezolizumab in combination with cobimetinib. Enrollment completed as of October 2019.
  • Experimental: 2L-2: Atezo + PEGPH20 (Gastric Cancer)
    Participants in the 2L-2 Gastric Cancer arm received atezolizumab in combination with PEGylated recombinant human hyaluronidase (PEGPH20). Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019.
  • Experimental: 2L-3: Atezo + BL-8040 (Gastric Cancer)
    Participants in the 2L-3 Gastric Cancer arm received atezolizumab in combination with BL-8040. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019.
  • Experimental: 2L-4: Atezo + Linagliptin (Gastric Cancer)
    Participants in the 2L-4 Gastric Cancer arm received atezolizumab in combination with linagliptin. Participants who progressed on treatment had the option of receiving Atezolizumab + Cobimetinib treatment, provided they met the eligibility criteria. Enrollment completed as of October 2019.
  • Experimental: 1L-1:Atezo+Tiragolumab+Cisplatin+5FU(Esophageal Cancer Cohort)
    Participants in the 1L-1 Esophageal Cancer arm will receive atezolizumab in combination with tiragolumab and chemotherapy.
  • Experimental: 1L-2: Atezo+Cisplatin+5-FU (Esophageal Cancer Cohort)
    Participants in the 1L-2 Esophageal Cancer arm will receive atezolizumab in combination with chemotherapy.
  • Active Comparator: 1L-Control: Cisplatin+5-FU (Esophageal Cancer Cohort)
    Participants in the 1L-Control Eophageal Cancer arm will receive chemotherapy.
  • Experimental: 1L-3: Atezo+Tiragolumab (Esophageal Cancer Cohort)
    Participants in the 1L-3 Esophageal Cancer arm will receive atezolizumab + tiragolumab treatment. Participants from the cisplatin + 5-FU esophageal cancer cohort arm may be permitted to enroll in this arm if they progress after receiving chemotherapy.

Geprüfte Regime

  • 5-Fluorouracil (5-FU):
    5-FU 2400 milligrams per square meter (mg/m^2) by continuous intravenous (IV) infusion over 46 hours on Days 1 and 2 and Days 15 and 16 of every 28-day cycle.
  • Leucovorin (Folinic acid):
    Leucovorin: 100 mg/m^2 IV over 2 hours on Days 1 and 15 of every 28-day cycle.
  • Oxaliplatin:
    Oxaliplatin: 100 mg/m^2 administered by IV infusion over 2 hours on Days 1 and 15 of every 28-day cycle.
  • Atezolizumab (Tecentriq):
    Atezolizumab: 840 mg by IV infusion on Days 1 and 15 of every 28-day cycle.
  • Cobimetinib (Cotellic):
    Cobimetinib: 60 mg by mouth once a day on Days 1-21 of every 28-day cycle
  • Ramucirumab:
    Ramucirumab: 8 mg/kg administered by IV infusion over 60 minutes on Days 1 and 15 of every 28-day cycle.
  • Paclitaxel:
    Paclitaxel: 80 mg/m^2 administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
  • PEGylated recombinant human hyaluronidase (PEGPH20):
    PEGPH20: 3 micrograms per kilogram (mcg/kg) administered by IV infusion on Days 1, 8, and 15 of every 21-day cycle.
  • BL-8040:
    BL-8040: 1.25 mg/kg administered by subcutaneous (SC) injection on Days 1-5 during the 5-day priming period prior to Cycle 1; 1.25 mg/kg administered by SC injection three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of every 21-day cycle).
  • Linagliptin:
    Linagliptin: 5 mg orally once a day of every 21-day cycle.
  • Atezolizumab (Tecentriq):
    Atezolizumab: 1200 mg administered by IV infusion on Day 1 of every 21-day cycle
  • Cobimetinib (Cotellic):
    Cobimetinib: 40 or 60 mg (depending on the recommended dose determined during the safety run-in phase) by mouth once a day on Days 1-21 of every 28-day cycle.
  • Cisplatin:
    Cisplatin: 80 mg/m^2 administered by IV infusion on Day 1 of each 21 day cycle. Treatment will be capped after 6 doses.
  • Tiragolumab (RO7092284):
    Tiragolumab: 600 mg administered by IV infusion on Day 1 of every 21 day cycle.
  • 5-Fluorouracil (5-FU):
    5-FU 800 mg/m^2 administerd by IV infusion on Days 1-5 of each 21 day cycle.

Quelle: ClinicalTrials.gov


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