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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. (CANOPY-N)

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ClinicalTrials.gov Identifier: NCT03968419
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: canakinumab Drug: pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)
Estimated Study Start Date : October 21, 2019
Estimated Primary Completion Date : June 28, 2021
Estimated Study Completion Date : November 4, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: canakinumab monotherapy
All patients will receive canakinumab (ACZ885) prior to surgery
Drug: canakinumab
Administered subcutaneously
Other Name: ACZ885

Experimental: canakinumab + pembrolizumab
All patients will receive canakinumab (ACZ885) and pembrolizumab prior to surgery
Drug: canakinumab
Administered subcutaneously
Other Name: ACZ885

Drug: pembrolizumab
200mg administered intravenously every 3 weeks

Experimental: pembrolizumab monotherapy
All patients will receive 2 doses of pembrolizumab prior to surgery
Drug: pembrolizumab
200mg administered intravenously every 3 weeks




Primary Outcome Measures :
  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 evaluable participants treated with canakinumab alone and in combination with pembrolizumab based on central review.


Secondary Outcome Measures :
  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 evaluable participants in 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 evaluable participants based on local review in each treatment arm.

  9. MPR based on both central & 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 randomized participants based on both central and local review in each treatment arm.

  10. 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 canakinumab + pembrolizumab combination and pembrolizumab alone based on central review.

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 is required for study enrollment. An archival biopsy is also acceptable if obtained up to 6 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.
  • 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, known or suspected autoimmune disease or documented history of autoimmune disease.
  • Subject with suspected or proven immunocompromised state or infections

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968419


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03968419     History of Changes
Other Study ID Numbers: CACZ885V2201C
2018-004813-42 ( EudraCT Number )
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ACZ885
canakinumab
pembrolizumab
NSCLC
non-small cell lung cancer
non small cell lung cancer
early stage NSCLC
squamous
non-squamous,
MPR
major pathological response
hs-CRP
PD-L1
hsCRP
surgery
neo-adjuvant
neo adjuvant
CD8
hs-IL-6
CANOPY

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs