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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
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Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

Rekrutierend

NCT-Nummer:
NCT04471428

Studienbeginn:
Oktober 2020

Letztes Update:
10.06.2021

Wirkstoff:
Cabozantinib, Atezolizumab, Docetaxel

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
Exelixis

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: GO41892 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 119)

Zentralklinik Bad Berka GmbH; Pneumologie
99437 Bad Berka
(Thüringen)
GermanyRekrutierend» Google-Maps
Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V
35392 Gießen
(Hessen)
GermanyRekrutierend» Google-Maps
KRH Klinikum Siloah-Oststadt-Heidehaus
30459 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Klinikum Koeln-Merheim; Lungenklinik
51109 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Giessen und Marburg
35043 Marburg
(Hessen)
GermanyRekrutierend» Google-Maps
Darmkrebszentrum im Brüderkrankenhaus St. Josef Paderborn
Husener Straße 46
33098 Paderborn
DeutschlandRekrutierend» Google-Maps
Med. Versorgungszentrum Weiden, Abteilung für Onkologie
92637 Weiden
(Bayern)
GermanyZurückgezogen» Google-Maps
Kaiser Permanente - San Diego
92120 San Diego
United StatesRekrutierend» Google-Maps
Sansum Clinic
93105 Santa Barbara
United StatesAktiv, nicht rekrutierend» Google-Maps
Rocky Mountain Cancer Centers
80220 Denver
United StatesRekrutierend» Google-Maps
Cancer Care Centers of Brevard
32955 Rockledge
United StatesRekrutierend» Google-Maps
Northwest Georgia Oncology Centers PC - Marietta
30060 Marietta
United StatesRekrutierend» Google-Maps
Quincy Medical Group; Canc Ctr at Blessing Hosp
62301 Quincy
United StatesRekrutierend» Google-Maps
Regional Cancer Care Associates
20817 Bethesda
United StatesRekrutierend» Google-Maps
Karmanos Cancer Center
48201 Detroit
United StatesAbgeschlossen» Google-Maps
Minnesota Oncology Hematology
55404 Minneapolis
United StatesRekrutierend» Google-Maps
San Juan Oncology Associates
87401 Farmington
United StatesRekrutierend» Google-Maps
Oncology Associates of Oregon, P.C
97401 Eugene
United StatesRekrutierend» Google-Maps
Consultants in Medical Oncology and Hematology
19008 Broomall
United StatesRekrutierend» Google-Maps
Charleston Oncology, P .A
29414 Charleston
United StatesRekrutierend» Google-Maps
Texas Oncology - Baylor Charles A. Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-Maps
Huntsman Cancer Institute at The University of Utah
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg
24060 Blacksburg
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists (Fairfax) - USOR
22031 Fairfax
United StatesRekrutierend» Google-Maps
Royal North Shore Hospital; Oncology
2065 St. Leonards
AustraliaRekrutierend» Google-Maps
Flinders Medical Centre
5042 Bedford Park
AustraliaRekrutierend» Google-Maps
Austin Hospital Olivia Newton John Cancer Centre
3084 Heidelberg
AustraliaRekrutierend» Google-Maps
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
8036 Graz
AustriaRekrutierend» Google-Maps
Ordensklinikum Linz Elisabethinen
4020 Linz
AustriaRekrutierend» Google-Maps
Lhk Feldkirch; Interne Medizin Abt.
6830 Rankweil
AustriaRekrutierend» Google-Maps
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
5020 Salzburg
AustriaRekrutierend» Google-Maps
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
1090 Wien
AustriaRekrutierend» Google-Maps
Cliniques Universitaires St-Luc
1200 Bruxelles
BelgiumRekrutierend» Google-Maps
CHU Angers,Service de Pneumologie
49933 Angers
FranceRekrutierend» Google-Maps
Hopital Dupuytren; Pneumologie
87042 Limoges
FranceRekrutierend» Google-Maps
Hôpital Saint Joseph; Oncologie Medicale
13285 Marseille
FranceRekrutierend» Google-Maps
Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
34298 Montpellier
FranceRekrutierend» Google-Maps
Centre Hospitalier de Mulhouse - Hopital Emile Muller
68070 Mulhouse
FranceRekrutierend» Google-Maps
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
115 22 Athens
GreeceRekrutierend» Google-Maps
Henri Dunant Hospital; Oncology Dept.
115 26 Athens
GreeceRekrutierend» Google-Maps
Uoa Sotiria Hospital; Oncology
115 27 Athens
GreeceRekrutierend» Google-Maps
Univ General Hosp Heraklion; Medical Oncology
711 10 Heraklion
GreeceRekrutierend» Google-Maps
Euromedical General Clinic of Thessaloniki; Oncology Department
546450 Thessaloniki
GreeceAktiv, nicht rekrutierend» Google-Maps
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
40138 Bologna
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria di Parma
43100 Parma
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
48100 Ravenna
ItalyAktiv, nicht rekrutierend» Google-Maps
Irccs Centro Di Riferimento Oncologico (CRO)
33081 Aviano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera San Camillo Forlanini; Farmacia
00149 Roma
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera San Camillo Forlanini
00152 Roma
ItalyRekrutierend» Google-Maps
Policlinico Umberto I, Oncologia B
00161 Roma
ItalyRekrutierend» Google-Maps
ASST Spedali Civili di Brescia
25123 Brescia
ItalyRekrutierend» Google-Maps
Istituto Clinico Humanitas
20089 Rozzano (MI)
ItalyRekrutierend» Google-Maps
Sendai Kousei Hospital
980-0873 Miyagi
JapanAktiv, nicht rekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanRekrutierend» Google-Maps
Kinki-Chuo Chest Medical Center
591-8555 Osaka
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Tokyo
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanRekrutierend» Google-Maps
Chungbuk National University Hospital
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
St. Vincent's Hospital
16247 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Medical Center
16499 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Samsung Changwon Hospital
51353 Gyeongsangnam-do
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul St Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ulsan University Hosiptal
44033 Ulsan
Korea, Republic ofRekrutierend» Google-Maps
Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
41-902 Bytom
PolandRekrutierend» Google-Maps
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
44-101 Gliwice
PolandRekrutierend» Google-Maps
Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii
75-581 Koszalin
PolandRekrutierend» Google-Maps
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
05-400 Otwock
PolandRekrutierend» Google-Maps
Hospital Pulido Valente; Servico de Pneumologia
1796-001 Lisboa
PortugalRekrutierend» Google-Maps
Hospital Pedro Hispano; Servico de Oncologia
4454-509 Matosinhos
PortugalRekrutierend» Google-Maps
Centro Hospitalar do Porto - Hospital de Santo António; Oncologia
4099-001 Porto
PortugalRekrutierend» Google-Maps
Hospital CUF Porto; Servico Pneumologia
4100-180 Porto
PortugalRekrutierend» Google-Maps
IPO do Porto; Servico de Oncologia Medica
4200-072 Porto
PortugalRekrutierend» Google-Maps
CHVNG/E_Unidade 1; Servico de Pneumologia
4434-502 Vila Nova De Gaia
PortugalAktiv, nicht rekrutierend» Google-Maps
Regional Clinical Oncology Hospital
150054 Yaroslavl
Russian FederationRekrutierend» Google-Maps
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
143422 Moscow
Russian FederationRekrutierend» Google-Maps
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
197758 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
GBUZ Leningradskaya state clinical hospital
194291 St. Petersburg
Russian FederationRekrutierend» Google-Maps
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
15006 A Coruña
SpainRekrutierend» Google-Maps
Hospital Univ Vall d'Hebron; Servicio de Oncologia
08035 Barcelona
SpainRekrutierend» Google-Maps
Institut Catala d Oncologia Hospital Duran i Reynals
08908 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario La Paz; Servicio de Oncologia
28046 Madrid
SpainRekrutierend» Google-Maps
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
41014 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
46015 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe; Oncologia
46026 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Addenbrookes Hospital
CB2 0QQ Cambridge
United KingdomRekrutierend» Google-Maps
Beatson West of Scotland Cancer Centre
G12 0YN Glasgow
United KingdomRekrutierend» Google-Maps
Huddersfield Royal Infirmary; The Learning Centre
HD3 3EA Huddersfield
United KingdomRekrutierend» Google-Maps
Barts & London School of Med; Medical Oncology
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
University College London Hospital
NW1 - 2PG London
United KingdomRekrutierend» Google-Maps
Royal Free Hospital
NW3 2QS London
United KingdomNoch nicht rekrutierend» Google-Maps
Chelsea & Westminster Hospital
SW10 9NH London
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a Phase III, multicenter, randomized, open-label study designed to evaluate the

efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib

compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing

EGFR mutation or ALK translocation, who have progressed following treatment with

platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or

sequentially.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic NSCLC

- Documented radiographic disease progression during or following treatment with

platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered

concurrently or sequentially for metastatic NSCLC

- Measurable disease per RECIST v1.1 outside CNS as assessed by investigator

- Known PD-L1 status or availability of tumor tissue for central PD-L1 testing

- ECOG Performance Status score of 0 or 1

- Recovery to baseline or Grade <=1 NCI CTCAE v5.0 from toxicities related to any prior

treatments, unless adverse events are clinically nonsignificant and/or stable on

supportive therapy in the opinion of the investigator

- Adequate hematologic and end-organ function

- Negative HIV test at screening

- Negative hepatitis B surface antigen (HBsAg) test at screening

- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total

HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening

- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody

test followed by a negative HCV RNA test at screening

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

heterosexual intercourse) or use contraception, and agreement to refrain from donating

eggs,

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

contraceptive methods, and agreement to refrain from donating sperm.

Exclusion Criteria:

- Prior therapy with the following agents for NSCLC: Cabozantinib, Docetaxel,

Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial

growth factor (VEGF)R targeting tyrosine kinase inhibitor (TKI)

- Treatment with investigational therapy within 28 days prior to initiation of study

treatment

- Documentation of known sensitizing mutation in the EGFR gene or ALK fusion oncogene

- Patients with known ROS1 rearrangements, BRAF V600E mutations, or other actionable

oncogenes with approved therapies if available

- Symptomatic, untreated, or actively progressing CNS metastases

- History of leptomeningeal disease

- Uncontrolled tumor-related pain

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

drainage procedures (more frequently than once monthly)

- Severe hepatic impairment

- Uncontrolled or symptomatic hypercalcemia

- Any other active malignancy at the time of initiation of study treatment or diagnosis

of another malignancy within 3 years prior to initiation of study treatment that

requires active treatment, except for locally curable cancers that have been

apparently cured, such as basal or squamous cell skin cancer, incidental prostate

cancer, or carcinoma in situ of the prostate, cervix, or breast

- Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic

events within 6 months of initiation of study treatment

- Significant vascular disease within 6 months of initiation of study treatment

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

treatment, unstable arrhythmia, or unstable angina

- Active tuberculosis

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

not limited to, hospitalization for complications of infection, bacteremia, or severe

pneumonia, or any active infection that, in the opinion on the investigator, could

impact patient safety

- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation

of study treatment

- Current treatment with anti-viral therapy for HBV

- 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

- Pregnant or lactating females, or intention of becoming pregnant during the treatment

with atezolizumab in combination with cabozantinib in the experimental arm or during

the treatment with docetaxel in the control arm, or within 5 months after the final

dose of atezolizumab and/or 4 months after the final dose of cabozantinib, whichever

is later.

- Ongoing Grade >= 2 sensory or motor neuropathy

- Active or history of autoimmune disease or immune deficiency, including, but not

limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus

erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid

antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome,

or multiple sclerosis with the following exceptions: Patients with a history of

autoimmune-mediated hypothyroidism who are on thyroid replacement hormone are eligible

for the study. Patients with controlled Type 1 diabetes mellitus are eligible for the

study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with

dermatologic manifestations only are eligible for the study provided all of following

conditions are met: Rash must cover < 10% of body surface area.

- Pharmacologically uncompensated, symptomatic hypothyroidism

- 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

- Prior allogeneic stem cell or solid organ transplantation

- Administration of a live, attenuated vaccine within 4 weeks prior to initiation of

study treatment or anticipation of need for such a vaccine during atezolizumab

treatment or within 5 months after the final dose of atezolizumab

- Treatment with systemic immunostimulatory agents (including, but not limited to,

interferon and interleukin 2) within 4 weeks or 5 drug-elimination half-lives

(whichever is longer) prior to initiation of study treatment

- Treatment with systemic immunosuppressive medication within 2 weeks prior to

initiation of study treatment, or anticipation of need for systemic immunosuppressive

medication during study treatment, with the following exceptions: Patients who

received acute, low-dose systemic immunosuppressant medication or a one-time pulse

dose of systemic immunosuppressant medication are eligible for the study after Medical

Monitor confirmation has been obtained. Patients who received mineralocorticoids,

inhaled or low-dose systemic corticosteroids for COPD or asthma, or low-dose

corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for

the study.

- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies

or fusion proteins

- Known hypersensitivity to Chinese hamster ovary cell products or to any component of

the atezolizumab formulation

- Known allergy or hypersensitivity to any component of the cabozantinib formulation

- History of severe hypersensitivity to docetaxel or to other drugs formulated with

polysorbate 80

- Concomitant anticoagulation with coumarin agents, direct thrombin inhibitor

dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors

- History of risk factors for torsades de pointes

- Corrected QT interval corrected through use of Fridericia's formula (QTcF) > 480 ms

per ECG within 14 days before initiation of study treatment

- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic

BP > 90 mm Hg despite optimal antihypertensive treatment

- Tumors invading the GI-tract, active peptic ulcer disease, acute pancreatitis, acute

obstruction of the pancreatic or biliary duct, appendicitis, cholangitis,

cholecystitis, diverticulitis, gastric outlet obstruction, or inflammatory bowel

disease

- Abdominal fistula, bowel obstruction, GI perforation, or intra-abdominal abscess

within 6 months before initiation of study treatment

- Known cavitating pulmonary lesion(s) or known endobronchial disease manifestation

- Lesions invading major pulmonary blood vessels

- Clinically significant hematuria, hematemesis, hemoptysis of > 0.5 teaspoon (2.5 mL)

of red blood, coagulopathy, or other history of significant bleeding within 3 months

before initiation of study treatment

- Serious non-healing wound/ulcer/bone fracture

- Malabsorption syndrome

- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase

deficiency, or glucose-galactose malabsorption are also excluded.

- Requirement for hemodialysis or peritoneal dialysis

- Inability to swallow tablets

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - Up to approximately 43 months):
Overall survival (OS) after randomization, defined as the time from randomization to death from any cause.



Secondary outcome:

1. PFS, as Determined by Investigator (Time Frame - Up to approximately 43 months):
PFS after randomization, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).

2. Confirmed Objective Response Rate (ORR), as Determined by Investigator (Time Frame - Up to approximately 43 months):
Confirmed objective response rate (ORR), defined as the proportion of participants with a complete or partial response on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.

3. Duration of response (DOR), as Determined by Investigator (Time Frame - Up to approximately 43 months):
Duration of response (DOR) for participants with confirmed ORR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).

4. Time to Confirmed Deterioration in Patient-Reported Physical Functioning (PF) (Time Frame - Up to approximately 43 months):
Time to confirmed deterioration in patient-reported physical functioning (PF) as measured by the corresponding scores from the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30).

5. Time to Confirmed Deterioration in Patient-Reported Global Health Status (GHS) (Time Frame - Up to approximately 43 months):
Time to confirmed deterioration in patient-reported Global Health Status (GHS) as measured by the corresponding scores from the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30).

6. PFS Rates Assessed by Investigator (Time Frame - 6 months and 1 year)

7. OS Rates (Time Frame - 1 and 2 years)

8. Percentage of Participants With Adverse Events (Time Frame - Up to approximately 43 months)

9. Minimum Serum Concentration (Cmin) of Atezolizumab (Time Frame - Predose and postdose on Day 1 of Cycle 1; and Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (each cycle is 21 days))

10. Maximum Serum Concentration (Cmax) of Atezolizumab (Time Frame - Predose and postdose on Day 1 of Cycle 1; and Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (each cycle is 21 days))

11. Minimum Serum Concentration (Cmin) of Cabozantinib (Time Frame - Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days))

12. Maximum Serum Concentration (Cmax) of Cabozantinib (Time Frame - Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days))

13. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab (Time Frame - Predose on Day 1 of Cycle 1 (each cycle is 21 days))

14. Number of ADAs to Atezolizumab After Treatment (Time Frame - Predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 (each cycle is 21 days))

Studien-Arme

  • Experimental: Atezolizumab + Cabozantinib
    Participants will receive atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on days 1-21 of each cycle.
  • Active Comparator: Docetaxel
    Participants will receive docetaxel on Day 1 of each 21-day cycle.

Geprüfte Regime

  • Cabozantinib:
    Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.
  • Atezolizumab (Tecentriq):
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
  • Docetaxel:
    Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.

Quelle: ClinicalTrials.gov


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