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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase I/II Study of MK-3475 With Gemcitabine in Patients With Previously-Treated Advanced Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02422381
• Other study ID #: 15-011A
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 20, 2015
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: August 2024
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• MK-3475
Investigational drug.
• Gemcitabine
Standard care drug.

Locations

Country	Name	City	State
United States	Providence Oncology & Hematology Care Clinic - Eastside	Portland	Oregon
United States	Providence Oncology & Hematology Care Clinic - Westside	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Providence Health & Services	Merck Sharp & Dohme LLC, Providence Cancer Center, Earle A. Chiles Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Toxicities (determine any changes in signs or symptoms that may represent drug toxicity)	Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity.	126 Days (six 21-day cycles)
Secondary	Progression Free Survival	Patients will have CT scans after every two cycles for up to 2 years to assess changes in tumor sizes.	2 years
Secondary	Overall Survival	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.	Every 12 weeks (up to 2 years)
Secondary	Disease Response	Patients will have CT scans to assess changes in tumor sizes.	up to 2 years

External Links

•   Providence Cancer Center