Study of Two Doses of MK-3475 (Pembrolizumab) Versus Docetaxel in Previously-Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01905657
First received: July 18, 2013
Last updated: October 1, 2014
Last verified: October 2014

July 18, 2013
October 1, 2014
August 2013
September 2015   (final data collection date for primary outcome measure)
  • Overall Survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Number of participants experiencing adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Number of participants discontinuing study drug due to adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01905657 on ClinicalTrials.gov Archive Site
  • Overall response rate (ORR) by RECIST 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Response duration by RECIST 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Two Doses of MK-3475 (Pembrolizumab) Versus Docetaxel in Previously-Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer

This study will compare two doses of pembrolizumab versus docetaxel in participants with non-small cell lung cancer (NSCLC) who have experienced disease progression after platinum-containing systemic therapy. Participants will be assigned randomly to receive either Low Dose or High Dose pembrolizumab every three weeks (Q3W), or docetaxel at 75 mg/m^2 Q3W. This study will use an adaptive trial design so that the total number of participants randomized will depend upon demonstration of sufficient objective responses at interim analysis. If the pembrolizumab Low Dose arm is closed, participants may receive pembrolizumab High Dose therapy.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer (NSCLC)
  • Biological: pembrolizumab
  • Drug: Docetaxel
  • Experimental: Pembrolizumab Low Dose
    Participants receive pembrolizumab, intravenously (IV) over 30 minutes Q3W
    Intervention: Biological: pembrolizumab
  • Experimental: Pembrolizumab High Dose
    Participants receive pembrolizumab, IV over 30 minutes Q3W
    Intervention: Biological: pembrolizumab
  • Active Comparator: Docetaxel 75 mg/m^2
    Participants receive 75 mg/m^2 docetaxel, IV over 1 hour Q3W
    Intervention: Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
920
January 2020
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Life expectancy of at least 3 months
  • Histologically- or cytologically-confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
  • At least one bi-dimensional measurable lesion
  • Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet
  • Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  • Prior therapy with docetaxel for NSCLC
  • Receiving systemic steroid therapy within three days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication
  • Expected to require any other form of systemic or localized antineoplastic therapy while on trial
  • History of allogeneic tissue/solid organ transplant
  • Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of >30 Gray within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug
  • Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), or took part in another pembrolizumab trial
  • Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
  • Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment
  • Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel
Both
18 Years and older
No
Contact: Toll Free Number 1-888-577-8839
United States,   Argentina,   Australia,   Belgium,   Canada,   Chile,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Netherlands,   Portugal,   Russian Federation,   South Africa,   Spain,   Taiwan,   United Kingdom
 
NCT01905657
3475-010, 2012-004391-19, 132355
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP