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A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
UCLA Department of Medicine, Division of Hematology/Oncology
Los Angeles, California, 90024 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy
which has progressed on standard therapy or for which no standard therapy is
available.

- Measurable disease per RECIST v1.1.

- Adequate bone marrow, renal and liver functioning

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- CNS primary malignancies, active seizure disorder or spinal cord compression, or
carcinomatous meningitis.

- History of any of the following toxicities associated with a prior immunotherapy:

- Grade 3 immune mediated adverse event that was considered related to previous
immunotherapy and required immune suppressive therapy;

- Grade 2 hepatic function related adverse event that persisted more than 1 week,
was considered related to immunotherapy, or required treatment discontinuation or
immunosuppressive therapy

- Any of the following within the 12 months prior to registration: myocardial
infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic
congestive heart failure, cerebrovascular accident or transient ischemic attack and 6
months for deep vein thrombosis or pulmonary embolism.

- History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4
interstitial fibrosis or interstitial lung disease, including a history of
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a
history of prior radiation pneumonitis. Patients with clinically significant lung
disease requiring oxygen therapy (eg, COPD).

NCT02179918
Pfizer
Completed
A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)

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A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)
A Phase 1b Study Of The 4-1bb Agonist Pf-05082566 In Combination With The Pd-1 Inhibitor Mk-3475 In Patients With Advanced Solid Tumors
This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in patients with solid tumors.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: PF-05082566
    Starting dose of 0.45 mg/kg q3wks IV, dose escalation
  • Drug: MK-3475
    2 mg/kg q3wks, IV
    Other Name: pembrolizumab
Experimental: PF-05082566 +MK-3475
PF-05082566 +MK-3475
Interventions:
  • Drug: PF-05082566
  • Drug: MK-3475
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
February 24, 2017
February 24, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available.
  • Measurable disease per RECIST v1.1.
  • Adequate bone marrow, renal and liver functioning

Exclusion Criteria:

  • CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis.
  • History of any of the following toxicities associated with a prior immunotherapy:

    • Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy;
    • Grade 2 hepatic function related adverse event that persisted more than 1 week, was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy
  • Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
  • History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02179918
B1641003
KEYNOTE-0036
No
Not Provided
Not Provided
Pfizer
Pfizer
Merck Sharp & Dohme Corp.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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