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

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Health & Services
• Collaborators: Merck Sharp & Dohme Corp.; Providence Cancer Center, Earle A. Chiles Research Institute
• Treatments: Gemcitabine; Pembrolizumab

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.