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

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

Tracking Information

• First Submitted Date: March 20, 2015
• First Posted Date: April 21, 2015
• Last Update Posted Date: September 10, 2022
• Actual Study Start Date: July 20, 2015
• Estimated Primary Completion Date: August 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 20, 2015)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 20, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)
• Official Title: A Phase I/II Study of MK-3475 With Gemcitabine in Patients With Previously-Treated Advanced Non-small Cell Lung Cancer (NSCLC)
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small-Cell Lung

Intervention

• Drug: MK-3475
  Investigational drug.
  Other Name: Anti-PD-1, Pembrolizumab
• Drug: Gemcitabine
  Standard care drug.
  Other Name: Gemzar

Study Arms

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.

Interventions:

• Drug: MK-3475
• Drug: Gemcitabine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 8, 2018): 16
• Original Estimated Enrollment (submitted: April 20, 2015): 46
• Estimated Study Completion Date: August 2024
• Estimated Primary Completion Date: August 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02422381
• Other Study ID Numbers: 15-011A
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Providence Health & Services
• Original Responsible Party: Same as current
• Current Study Sponsor: Providence Health & Services
• Original Study Sponsor: Same as current

Collaborators

• Merck Sharp & Dohme LLC
• Providence Cancer Center, Earle A. Chiles Research Institute

Investigators

• Principal Investigator: Rachel Sanborn, MD; Providence Health & Services

• PRS Account: Providence Health & Services
• Verification Date: September 2022