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Trial record 18 of 259 for:    Venetoclax

A Safety Study of Oral Venetoclax in Combination With Intravenous Pembrolizumab in Adult Participants With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) With High Programmed Cell Death Ligand-1 (PD-L1) Expression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04274907
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. It is the most common form of lung cancer, accounting for around 85% of lung cancers. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of Venetoclax in combination with Pembrolizumab in participants with NSCLC.

Venetoclax is a drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. Pembrolizumab is approved drug for the treatment of NSCLC. It works with your immune system to help fight certain cancers. The study is split into two portions - dose escalation and randomization. Participants are assigned one of the three treatment groups to receive pembrolizumab alone or in combination with venetoclax. Each group receives a different treatment. Participants who are at least 18 years of age with a diagnosis of NSCLC will be enrolled. Around 100 participants will be enrolled in the study in approximately 44 sites across United States.

Participants will receive intravenous (IV) infusion of pembrolizumab alone or in combination with oral venetoclax tablets.

There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Cancer Drug: Venetoclax Drug: Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Venetoclax in Combination With Pembrolizumab in Subjects With Previously Untreated NSCLC Whose Tumors Have High PD-L1 Expression
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : April 26, 2022
Estimated Study Completion Date : January 11, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation Phase: Venetoclax + Pembrolizumab
Participants will receive escalating doses of venetoclax in combination with pembrolizumab dose A
Drug: Venetoclax
Tablet: Oral
Other Names:
  • Venclexta
  • ABT-199

Drug: Pembrolizumab
Intravenous (IV) Infusion
Other Name: Keytruda

Experimental: Randomization Phase: Venetoclax + Pembrolizumab
Participants will receive venetoclax at dose levels determined in the dose escalation phase in combination with pembrolizumab dose A
Drug: Venetoclax
Tablet: Oral
Other Names:
  • Venclexta
  • ABT-199

Drug: Pembrolizumab
Intravenous (IV) Infusion
Other Name: Keytruda

Active Comparator: Randomization Phase: Pembrolizumab Monotherapy
Participants will receive pembrolizumab dose A
Drug: Pembrolizumab
Intravenous (IV) Infusion
Other Name: Keytruda




Primary Outcome Measures :
  1. Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 28 Days ]
    DLTs are adverse events that are considered to have a reasonable possibility of relationship to the administration of venetoclax and pembrolizumab and cannot be attributed by the investigator to a clearly identifiable cause such as disease progression, concurrent illness or concomitant medication.

  2. Change in the Sum of the Longest Diameter (SLD) [ Time Frame: Up to 35 Cycles (Each Cycle is 21 Days) ]
    Change in the SLD is assessed by exposure-response modeling


Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of Venetoclax [ Time Frame: Up to Cycle 1 (Each Cycle is 21 Days) ]
    Maximum plasma concentration (Cmax) of venetoclax

  2. Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax [ Time Frame: Up to Cycle 1 (Each Cycle is 21 Days) ]
    Time to maximum observed plasma concentration (Tmax) of venetoclax

  3. Area Under the Plasma Concentration-Time Curve Over Time from 0 to 24 (AUC0-24) of Venetoclax in Plasma [ Time Frame: Up to Cycle 1 (Each Cycle is 21 Days) ]
    Area Under the Plasma Concentration-time Curve (AUC) from 0-24 (AUC0-24)

  4. Objective Response Rate (ORR) [ Time Frame: Up to 35 Cycles (Each Cycle is 21 Days) ]
    ORR will be defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR).



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

Inclusion Criteria:

  • Histologically documented advanced or metastatic NSCLC with no known epidermal growth factor receptor (EGFR) sensitizing (activating) mutation or anaplastic lymphoma kinase (ALK) translocation.
  • At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
  • High PD-L1 tumor expression (tumor proportion score >= 50%) as determined by a Food and Drug Administration (FDA)-approved test.
  • Willing to provide tissue biopsy sample prior to start of study and during treatment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  • Received prior systemic treatment for their advanced or metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
  • History of or ongoing interstitial lung disease or pneumonitis that required oral or intravenous (IV) steroids.
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

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): NCT04274907


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 39 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04274907    
Other Study ID Numbers: M19-700
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Non Small Cell Lung Cancer (NSCLC)
Cancer
Venetoclax
Pembrolizumab
PD-L1 Expression
ABT-199
Additional relevant MeSH terms:
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Venetoclax
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
Antineoplastic Agents, Immunological
Antineoplastic Agents