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Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer (KEYNOTE166)

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ClinicalTrials.gov Identifier: NCT02448303
Recruitment Status : Unknown
Verified November 2016 by Acerta Pharma BV.
Recruitment status was:  Active, not recruiting
First Posted : May 19, 2015
Last Update Posted : December 1, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Pembrolizumab Drug: Acalabrutinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Non-small Cell Lung Carcinoma
Study Start Date : May 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
pembrolizumab
Drug: Pembrolizumab
Other Name: Keytruda

Experimental: Arm 2
acalabrutinib plus pembrolizumab
Drug: Pembrolizumab
Other Name: Keytruda

Drug: Acalabrutinib
Other Name: ACP-196




Primary Outcome Measures :
  1. The overall response rate (ORR) of pembrolizumab monotherapy and the combination of acalabrutinib and pembrolizumab in subjects with recurrent or metastatic NSCLC [ Time Frame: 52 weeks ]


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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:

  • Men and women ≥ 18 years of age
  • ECOG performance status of 0 or 1
  • Histologically confirmed recurrent or metastatic NSCLC (adenocarcinoma, large cell, squamous cell, or not otherwise specified) that has either progressed during or after platinum-based chemotherapy
  • Received at least 1 platinum-based chemotherapy regimen. Note: Subjects with EGFR mutations or ALK translocations are required to have received prior therapy with appropriate TKI; prior platinum-based chemotherapy is not required for this specific patient population

Exclusion Criteria:

  • Prior malignancy (other than lung cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
  • Known central nervous system metastases and/or carcinomatous meningitis
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
  • Breastfeeding or pregnant

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): NCT02448303


Locations
United States, Arizona
Western Regional Medical Center/Cancer Treatment Center of America
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Acerta Pharma BV
Merck Sharp & Dohme Corp.
Investigators
Study Director: Linda Bavisotto, MD Acerta Pharma, LLC

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02448303     History of Changes
Other Study ID Numbers: ACE-ST-007
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents