Donnerstag, 2. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
eVOLVE-Meso

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Rekrutierend

NCT-Nummer:
NCT06097728

Studienbeginn:
November 2023

Letztes Update:
22.04.2024

Wirkstoff:
Volrustomig, Pemetrexed, Carboplatin, Cisplatin, Nivolumab, Ipilimumab

Indikation (Clinical Trials):
Mesothelioma, Mesothelioma, Malignant

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

Marjorie G Zauderer, MD
Principal Investigator
Memorial Slone Kettering (MSK) Cancer Centre, NY
Arnaud Scherpereel, MD
Principal Investigator
Lille University

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations
(3 von 149)

Research Site
13125 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
45130 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
82131 Gauting
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
49124 Georgsmarienhuette
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
69126 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
51109 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
48163 Münster
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
85054 Phoenix
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
80045 Aurora
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
32224 Jacksonville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
30322 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
55905 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
63110 Saint Louis
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
08816 East Brunswick
United StatesZurückgezogen» Google-Maps
Research Site
11725 Commack
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
44195 Cleveland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
97213 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
97239 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
19104 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
77030 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
22031 Fairfax
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
9100 Sint-Niklaas
BelgiumNoch nicht rekrutierend» Google-Maps
Research Site
60336-045 Fortaleza
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
58013-140 Joao Pessoa
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
91350-200 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
22281-100 Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
09060-650 Santo Andre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
01246-000 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
94010 Creteil Cedex
FranceNoch nicht rekrutierend» Google-Maps
Research Site
72037 Le Mans Cedex
FranceNoch nicht rekrutierend» Google-Maps
Research Site
13015 Marseille Cedex 20
FranceNoch nicht rekrutierend» Google-Maps
Research Site
75877 Paris Cedex 18
FranceNoch nicht rekrutierend» Google-Maps
Research Site
44800 Saint Herblain
FranceNoch nicht rekrutierend» Google-Maps
Research Site
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
Research Site
1066CX Amsterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
Research Site
5623EJ Eindhoven
NetherlandsNoch nicht rekrutierend» Google-Maps
Research Site
3015 GD Rotterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
Research Site
4126 Amanzimtoti
South AfricaNoch nicht rekrutierend» Google-Maps
Research Site
2013 Johannesburg
South AfricaNoch nicht rekrutierend» Google-Maps
Research Site
7570 Kraaifontein
South AfricaNoch nicht rekrutierend» Google-Maps
Research Site
2193 Parktown
South AfricaNoch nicht rekrutierend» Google-Maps
Research Site
0002 Pretoria
South AfricaNoch nicht rekrutierend» Google-Maps
Research Site
0081 Pretoria
South AfricaNoch nicht rekrutierend» Google-Maps
Research Site
NW1 2PG London
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
TS4 3BW Middlesborough
United KingdomRekrutierend» Google-Maps
Research Site
NE2 4HH Newcastle-upon-Tyne
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced

unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive

Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of

platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- Participant must be ≥ 18 years at the time of screening

- Histologically proven diagnosis of pleural mesothelioma with known histology

(epithelioid vs. non-epithelioid)

- Advanced unresectable disease that cannot be treated with curative surgery (with or

without chemotherapy)

- WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS>1) over

the previous 2 weeks prior to day of first dosing

- Has measurable disease per modified RECIST1.1

- Has adequate bone marrow reserve and organ function at baseline

Key Exclusion Criteria:

- As judged by the investigator, any condition that would interfere with evaluation of

the investigational product or interpretation of participant safety or study results.

- Active or prior documented autoimmune or inflammatory disorders

- History of another primary malignancy with exceptions.

- Uncontrolled intercurrent illness

- Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus

(HIV) infection that is not well controlled

- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal

therapy for cancer treatment

- Untreated or progressive CNS metastatic disease

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) in experimental arm relative to comparator arm (Time Frame - up to approximately 52 months):
OS is defined as the time from randomization until the date of death due to any cause.



Secondary outcome:

1. Overall Survival (OS) (Time Frame - up to approximately 52 months):
OS is defined as the time from randomization until the date of death due to any cause.

2. Progression Free Survival (PFS) (Time Frame - up to approximately 52 months):
PFS is defined as the time from randomization until progression per mRECIST 1.1 and/or RECIST 1.1 as assessed by the investigator at local site, or death due to any cause.

3. Landmark OS (Time Frame - 12, 18, 24, 36 months):
Landmarks of OS12, OS18, OS24, and OS36.

4. Landmark PFS (Time Frame - 6, 12, 18, 24 months):
Landmarks of PFS6, PFS12, PFS18, and PFS24

5. Overall Response Rate (ORR) (Time Frame - up to approximately 52 months):
Proportion of participants who have a confirmed Complete Response or confirmed Partial Response, as determined by the investigator at local site per mRECIST 1.1 and/or RECIST 1.1.

6. Duration of Response (DoR) (Time Frame - up to approximately 52 months):
DoR defined as the time from the date of first documented response until date of documented progression per mRECIST 1.1 and/or RECIST 1.1 as assessed by the investigator at local site or death due to any cause.

7. PFS2 (Time Frame - up to approximately 52 months):
PFS2 defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.

8. Patient-reported physical functioning (Time Frame - up to approximately 52 months.):
TTD in physical functioning as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Short Form 8c. There are 8 questions each from a scale of 1 (unable to do) to a scale of 5 (With a little difficulty). The higher the scores the better the patient-reported physical functioning is.

9. Disease-related symptoms using EORTC IL305 (Q1) (Time Frame - Up to approximately 52 months.):
Change from baseline in disease-related symptoms as measured by individual symptom items from the EORTC (European Organisation For Research And Treatment Of Cancer) IL305 (Item Library 305) (Q1). It is scored from a 1 (not at all) to a 4 (very much). The higher the score the higher the disease-related symptoms.

10. Disease-related symptoms using PRO-CTCAE (Q1, 5, 6, 9) (Time Frame - Up to approximately 52 months):
Change from baseline in disease-related symptoms as measured by individual symptom items from the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) (Q1, 5, 6, 9). PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). The higher the score the higher the disease-related symptoms.

11. Patient-reported role functioning using EORTC QLQ-C30 RF subscale (IL305 Q2 3) (Time Frame - up to approximately 52 months):
Change from baseline in functioning will be assessed by the following measure: Role functioning: EORTC (European Organisation For Research And Treatment Of Cancer) QLQ (Quality of Life Questionnaire) -C30 RF (Role Functioning) subscale (IL305 Q2 3) (Item Library 305). The questions are from a scale of 1 (not at all) to 4 (very much). The lower the score the higher the patient-reported role functioning is.

12. Patient-reported HRQoL (Health-related Quality of Life) using EORTC QLQ-C30 HRQoL subscale (IL305 Q7-8) (Time Frame - Up to approximately 52 months):
Change from baseline in functioning will be assessed by the following measure: HRQoL: EORTC (European Organisation For Research And Treatment Of Cancer) QLQ (Quality of Life Questionnaire) -C30 HRQoL subscale (IL305 Q7-8) (Item Library 305). The questions are from a scale of 1 (very poor) to 7 (excellent). The higher the score the higher the HRQoL.

13. Immunogenicity of volrustomig (Time Frame - up to approximately 52 months):
Incidence of Anti-Drug Antibodies against volrustomig.

14. Incidence of Adverse Events (AEs) AEs graded by CTCAE version 5.0 (Time Frame - Up to approximately 52 months):
Incidence of Adverse Events (AEs) AEs graded by CTCAE (Common Terminology Criteria for Adverse Events) version 5.0. Grade refers to the severity of the AE. The CTCAE displays grade 1 (mild) through 5 (death related to AE). Grade 2 (moderate), Grade 3 (Severe) and Grade 4 (Life-threatening consequences).

15. Area under the curve (AUC) (Time Frame - Up to approximately 52 months):
The concentration of MEDI5752 in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

16. Maximum plasma concentration of the drug (Cmax) (Time Frame - Up to approximately 52 months):
The concentration of MEDI5752 in serum will be determined (Cmax will be derived).

17. The time taken to reach the maximum concentration (Tmax) (Time Frame - Up to approximately 52 months):
The concentration of MEDI5752 in serum will be determined (Tmax will be derived).

Studien-Arme

  • Experimental: Volrustomig + Carboplatin + pemetrexed
    Volrustomig in combination with carboplatin plus pemetrexed
  • Active Comparator: Investigator's choice of standard care
    The investigator's choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology.

Geprüfte Regime

  • Volrustomig (MEDI5752):
    MEDI5752: Administered as IV infusion
  • Pemetrexed (Alimta):
    Alimta: Administered as IV infusion
  • Carboplatin (Paraplatin):
    Paraplatin: Administered as IV infusion
  • Cisplatin (Platinol):
    Platinol: Administered as IV infusion
  • Nivolumab (Opdivo):
    Opdivo: Administered as IV infusion
  • Ipilimumab (Yervoy):
    Yervoy: Administered as IV infusion

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.