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Canakinumab
 
JOURNAL ONKOLOGIE – STUDIE

CANOPY-N This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.

Rekrutierend

NCT-Nummer:
NCT03968419

Studienbeginn:
November 2019

Letztes Update:
19.10.2020

Wirkstoff:
Canakinumab, Pembrolizumab

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Studienlocations (3 von 36)

Novartis Investigative Site
99437 Bad Berka
(Thüringen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
35392 Giessen
(Hessen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
51109 Koeln
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Novartis Investigative Site
1000 Bruxelles
BelgiumRekrutierend» Google-Maps
Novartis Investigative Site
34059 Montpellier cedex 5
FranceRekrutierend» Google-Maps
Novartis Investigative Site
57001 Thessaloniki
GreeceRekrutierend» Google-Maps
Novartis Investigative Site
2045 Torokbalint
HungaryRekrutierend» Google-Maps
Novartis Investigative Site
277 8577 Kashiwa
JapanRekrutierend» Google-Maps
Novartis Investigative Site
5200 Hertogenbosch
NetherlandsRekrutierend» Google-Maps
Novartis Investigative Site
6229 HX Maastricht
NetherlandsRekrutierend» Google-Maps
Novartis Investigative Site
3508 GA Utrecht
NetherlandsRekrutierend» Google-Maps
Novartis Investigative Site
644013 Omsk
Russian FederationRekrutierend» Google-Maps
Novartis Investigative Site
197022 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Novartis Investigative Site
195271 St Petersburg
Russian FederationRekrutierend» Google-Maps
Novartis Investigative Site
06100 Sihhiye / Ankara
TurkeyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

Major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR rate of pembrolizumab as a single agent. Additionally the dynamics of the tumor microenvironment changes on treatment by comparing pre-, on- and post-treatment samples will be evaluated.

Ein-/Ausschlusskriterien

Key inclusion criteria:

- Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors.

- Subject must be eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment).

- A mandatory newly obtained tissue biopsy from primary site is required for study enrollment. An archival biopsy is also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment.

Note: Aspirates will not be accepted.

- Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.

Key exclusion criteria:

- Subjects with unresectable or metastatic disease.

- History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction

- Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening

- Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy is permitted

- Subject with suspected or proven immunocompromised state or infections

Other protocol-defined inclusion/exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Major Pathological Response (MPR) rate based on Central review (Time Frame - At time of surgery (approximately 4 - 6 weeks after first dose)):
This will assess the rate of MPR at the time of surgery in all participants randomized to canakinumab alone and in combination with pembrolizumab arms based on central review.



Secondary outcome:

1. Antidrug antibodies (ADA) of canakinumab (Time Frame - Predose (0 hour) on Day 1 of Cycles 1 and 2 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose):
To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of canakinumab

2. Antidrug antibodies (ADA) of pembrolizumab (Time Frame - Predose (0 hour) on Day 1 of Cycles 1 and 2 (Cycle length =21 days), at end of treatment and then at 26 days after last dose):
To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of pembrolizumab

3. Overall response rate (ORR) per investigator assessment using RECIST v1.1 (Time Frame - From date of randomization to date of surgery up to 6 weeks):
ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1

4. Serum canakinumab concentration (Time Frame - Predose (0 hour) on Day 1 of Cycles 1 and 2 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose):
To characterize the pharmacokinetics of canakinumab therapy

5. Serum pembrolizumab concentration (Time Frame - Predose (0 hour) on Day 1 of Cycles 1 and 2 (Cycle length =21 days), end of infusion on Day 1 Cycle 1, at end of treatment and then at 26 days after last dose):
To characterize the pharmacokinetics of pembrolizumab therapy

6. Surgical feasibility rate (Time Frame - 4 to 6 weeks after first dose):
To assess the rate of the surgical feasibility

7. MPR based on central review (Time Frame - At time of surgery (approximately 4 - 6 weeks after first dose)):
This will assess the rate of MPR at the time of surgery in all participants randomized to pembrolizumab monotherapy arm based on central review.

8. MPR based on local review (Time Frame - At time of surgery (approximately 4 - 6 weeks after first dose)):
This will assess the rate of MPR at the time of surgery in all randomized participants based on local review in each treatment arm.

9. Difference in MPR rate based on central review (Time Frame - At time of surgery (approximately 4 - 6 weeks after first dose)):
This will estimate the difference in MPR and posterior probability of the difference in MPR ≥ 10% between participants randomized to canakinumab + pembrolizumab combination and pembrolizumab alone based on central review.

10. MPR rate based on the levels of biomarkers (Time Frame - From date of randomization to 130 days after last dose of drug):
Biomarkers include PD-L1, CD8, hs-CRP, hs-IL-6

Studien-Arme

  • Experimental: canakinumab monotherapy
    All patients will receive canakinumab (ACZ885) prior to surgery
  • Experimental: canakinumab + pembrolizumab
    All patients will receive canakinumab (ACZ885) and pembrolizumab prior to surgery
  • Experimental: pembrolizumab monotherapy
    All patients will receive 2 doses of pembrolizumab prior to surgery

Geprüfte Regime

  • canakinumab (ACZ885):
    Administered subcutaneously
  • pembrolizumab:
    200mg administered intravenously every 3 weeks

Quelle: ClinicalTrials.gov


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