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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MK-3475

Gemcitabine

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring NSCLC, lung cancer, Gemzar, Pembrolizumab, Anti-PD-1, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Providence Oncology & Hematology Care Clinic - Eastside
Providence Oncology & Hematology Care Clinic - Westside

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MK-3475 + Gemcitabine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression Free Survival

Patients will have CT scans after every two cycles for up to 2 years to assess changes in tumor sizes.

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.

Disease Response

Patients will have CT scans to assess changes in tumor sizes.

Full Information

NCT ID

NCT02422381

First Posted

March 20, 2015

Last Updated

September 9, 2022

Sponsor

Providence Health & Services

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02422381

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 20, 2015 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Providence Health & Services

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC, lung cancer, Gemzar, Pembrolizumab, Anti-PD-1, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MK-3475 + Gemcitabine

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

MK-3475

Other Intervention Name(s)

Anti-PD-1, Pembrolizumab

Intervention Description

Investigational drug.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

Standard care drug.

Primary Outcome Measure Information:

Title

Frequency of Toxicities (determine any changes in signs or symptoms that may represent drug toxicity)

Description

Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity.

Time Frame

126 Days (six 21-day cycles)

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

Patients will have CT scans after every two cycles for up to 2 years to assess changes in tumor sizes.

Time Frame

2 years

Title

Overall Survival

Description

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.

Time Frame

Every 12 weeks (up to 2 years)

Title

Disease Response

Description

Patients will have CT scans to assess changes in tumor sizes.

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel Sanborn, MD

Organizational Affiliation

Providence Health & Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Providence Oncology & Hematology Care Clinic - Eastside

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Providence Oncology & Hematology Care Clinic - Westside

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://oregon.providence.org/our-services/p/providence-cancer-center/

Description

Providence Cancer Center

Learn more about this trial

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

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