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MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT02422381
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : September 10, 2022
Merck Sharp & Dohme LLC
Providence Cancer Center, Earle A. Chiles Research Institute
Information provided by (Responsible Party):
Providence Health & Services

Brief Summary:
This is a study for patients with previously-treated advanced non-small cell lung cancer (NSCLC). The study will evaluate the safety of adding an investigational drug, MK-3475 to standard treatment with gemcitabine. The study will also try to identify the best dose of MK-3475 to give in combination with gemcitabine.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: MK-3475 Drug: Gemcitabine Phase 1 Phase 2

Detailed Description:
This study is an open-label, non-randomized phase I study, followed by open-label non-randomized phase II study. The first cohort of patients will receive 200 milligrams (mg) of MK-3475 by intravenous infusion over a 21-day period called a cycle along with Gemcitabine 1250 mg/m2 given on Days 1 and 8 of each 21-day cycle for up to 6 cycles. Patients will be seen in the study clinic 12 times over 126 days for an evaluation of signs and symptoms that may represent drug toxicity. Patients may continue to receive MK-3475 (without gemcitabine) for up to 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of MK-3475 With Gemcitabine in Patients With Previously-Treated Advanced Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : July 20, 2015
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: MK-3475 + Gemcitabine
200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
Drug: MK-3475
Investigational drug.
Other Name: Anti-PD-1, Pembrolizumab

Drug: Gemcitabine
Standard care drug.
Other Name: Gemzar

Primary Outcome Measures :
  1. Frequency of Toxicities (determine any changes in signs or symptoms that may represent drug toxicity) [ Time Frame: 126 Days (six 21-day cycles) ]
    Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity.

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
    Patients will have CT scans after every two cycles for up to 2 years to assess changes in tumor sizes.

  2. Overall Survival [ Time Frame: Every 12 weeks (up to 2 years) ]
    Patients will be contacted every 12 weeks following end of treatment to determine survival status until death, withdrawal of consent, or the end of the study, whichever occurs first.

  3. Disease Response [ Time Frame: up to 2 years ]
    Patients will have CT scans to assess changes in tumor sizes.

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

Inclusion Criteria:

  • Women or men with advanced, histologically proven NSCLC.
  • Patients must have received at least one but no more than three prior systemic therapies for advanced disease.
  • Any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with anti-PD1 therapy or gemcitabine should be resolved to less than Grade 1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Women of childbearing potential must have a negative pregnancy test
  • Ability to give informed consent and comply with the protocol.
  • Anticipated survival minimum 3 months.
  • Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
  • Patients must have normal organ and marrow function as seen on protocol-defined blood test results
  • Archived tumor tissue (minimum of 8 slides for paraffin-embedded tumor tissue) available
  • Measurable disease by RECIST 1.1 criteria.
  • Treated brain metastases will be allowed, provided they are asymptomatic.
  • Radiation for symptomatic lesions outside the Central nervous system (CNS) must have been completed at least 2 weeks prior to study enrollment.

Exclusion Criteria:

  • Prior therapy with any anti-PD-1, anti-PD-L1, or anti-CTLA4 antibody.
  • Prior therapy with gemcitabine.
  • Prior complications from radiation, such as history of radiation pneumonitis or pulmonary edema that, in the opinion of the investigator, may have risk of increasing toxicity with anti-PD1 therapy.
  • Active autoimmune disease except vitiligo or stable hypothyroidism.
  • Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, cardiopulmonary disease (COPD), allergic rhinitis).
  • Active other malignancy, except for controlled basal cell skin carcinoma.
  • HIV positive and/or Hepatitis B or C positive.
  • Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in this protocol.

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): NCT02422381

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United States, Oregon
Providence Oncology & Hematology Care Clinic - Eastside
Portland, Oregon, United States, 97213
Providence Oncology & Hematology Care Clinic - Westside
Portland, Oregon, United States, 97225
Sponsors and Collaborators
Providence Health & Services
Merck Sharp & Dohme LLC
Providence Cancer Center, Earle A. Chiles Research Institute
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Principal Investigator: Rachel Sanborn, MD Providence Health & Services
Additional Information:
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02422381    
Other Study ID Numbers: 15-011A
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Providence Health & Services:
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological