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A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as first line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1)

About this Study

-To determine the RP3R of Canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy.
-To compare patient free survival by local investigator assessment and overall survival between the two treatment arms. 
-To assess the preliminary clinical anti-tumor activity of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy. 
-To characterize the safety and tolerability of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy. 
-To characterize the pharmacokinetics of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy. 

Sponsor Protocol ID:CACZ885U2301
IRB Number:2019-0119
Study Status:

Study Status

Actively Enrolling: The study is currently recruiting participants.

Closed for Enrollment: The study is not currently recruiting participants.

Closed for Enrollment
Study Type:

Study Type

Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.

Interventional
Study Phase:

Study Phase

Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

Phase 3
Online Start Date:

Online Start Date

The online start date is the day that this trial first appeared on the UMMC website, which is not necessarily the day that the trial first began at UMMC.

June 24, 2019
Eligibility Criteria
Minimum Age

Age Requirement

Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.

18 years old
Maximum Age

Age Requirement

Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.

100 years old
Biological Sex

Biological Sex Requirement

Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

 Both Male and Female
Cancer Related?

Cancer Related

Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

Yes
Pediatric Related?

Pediatric Related

Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Indicates whether people who do not have the condition/disease being studied can participate in the clinical study.

Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.

No

Inclusion Criteria1. Written informed consent must be obtained prior to any screening procedures.

 2. Adult male/female ≥ 18 years of age at the time of informed consent 

3. Subject is able to communicate with the investigator, and has the ability to comply with the requirements of the study procedures

Exclusion Criteria

10. Subject with suspected or proven immunocompromised state or infections, including: 
  •  Evidence of active or latent tuberculosis (TB) as determined by locally approved screening methods. If presence of TB (active or latent) is established then treatment for TB must have been completed according to locally approved country guidelines prior to screening for the study. 
  • Chronic or active hepatitis B or C 
  • Known history of testing positive for Human Immunodeficiency Virus (HIV) infections. For countries where HIV status is mandatory: testing positive for HIV during screening using a local test. 
  •  Any other medical condition (such as active infection, treated or untreated), which in the opinion of the investigator places the patient at an unacceptable risk for participation in immunomodulatory therapy. 
  •  Note: Subjects with localized condition unlikely to lead to a systemic infection e.g. chronic nail fungal infection are eligible. 
  • Allogeneic bone marrow or solid organ transplant 
  •  Treatment with any immune modulating agent in doses with systemic effects e.g.:  
  •  Note: Daily glucocorticoid-replacement for conditions such as adrenal or pituitary insufficiency is allowed. 
  •  Note: Topical, inhaled, or local steroid use in doses that are not considered to cause systemic effects are permitted. 
  •  Note: Steroids for pre-medication related to chemotherapy as per local standard of care are permitted. 

11. Subject has received live vaccination within 3 months prior to first dose of study drug. 

12. Subject has had major surgery 

15. History of or active interstitial lung disease. 

16. Subject has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study, or compromise compliance with the protocol (e.g. chronic pancreatitis, uncontrolled diabetes mellitus). 

18. Patient is concurrently using other anti-cancer therapy 

19. Participation in a prior investigational study (drug or device) within 30 days prior to enrollment or randomization or within 5-half lives of the investigational product, whichever is longer, or those who are exppected to receive any other investigational drug or device during the conduct of the study.

20. Pregnant or breast-feeding (lactating) women, or women who plan to become pregnant or breast-feed during the study, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 

21. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during the study and 6 months after study treatment discontinuation. Highly effective contraception methods include: 
  •  Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception) 
  •  Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment 
  •  Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient. 
  •  Use of oral (estrogen and progesterone), injected or implanted combined hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate
22. Sexually active males unless they use a condom during intercourse while taking chemotherapy drug(s) and for 6 months after stopping chemotherapy treatment, and should not father a child in this period or as per the local label. A condom is required to be used also by vasectomized men in order to prevent delivery of the chemotherapy drug(s) via seminal fluid.


Categories Click category to view its trials.
Cancer
Lungs/Breathing
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jennifer Barnes
Phone Number: 601-815-4540
Email: jbarnes@umc.edu
Principal Investigator:John Ruckdeschel
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