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Anti-metabolites

MK-3475 + Gemcitabine for Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Rachel Sanborn, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Prior therapy with any anti-PD-1, anti-PD-L1, or anti-CTLA4 antibody
Prior therapy with gemcitabine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks (up to 2 years)
Awards & highlights

Summary

This trial is for patients with advanced NSCLC who have been treated before. It will test the safety of adding MK-3475 (an investigational drug) to standard treatment with gemcitabine, as well as trying to identify the best dose of MK-3475 to give in combination with gemcitabine.

Who is the study for?
This trial is for men and women with advanced NSCLC who have had 1-3 prior treatments but not with anti-PD-1, anti-PD-L1, or gemcitabine. Participants must be in good health otherwise, have a life expectancy of at least 3 months, and cannot be pregnant. They should not have active autoimmune diseases (except stable hypothyroidism or vitiligo), other cancers except controlled skin carcinoma, or serious medical conditions.Check my eligibility
What is being tested?
The study tests the safety of adding MK-3475 to standard gemcitabine treatment in advanced NSCLC patients. It aims to find the best dose for this combination therapy. Patients will receive MK-3475 alongside their regular chemotherapy regimen to see how well they work together.See study design
What are the potential side effects?
Possible side effects include those common to immunotherapy like fatigue, skin reactions, inflammation-related symptoms affecting various organs including lungs (pneumonitis), as well as typical chemotherapy side effects such as nausea and low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced non-small cell lung cancer confirmed by a biopsy.
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I have had 1 to 3 treatments for my advanced disease.
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I am capable of becoming pregnant and have a negative pregnancy test.
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My blood tests for organ and marrow function are normal.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with drugs targeting PD-1, PD-L1, or CTLA4.
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I have been treated with gemcitabine before.
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I have an autoimmune disease, but it's either vitiligo or stable hypothyroidism.
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I have no active cancer except for treated skin cancer.
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I am HIV positive or have Hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks (up to 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks (up to 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Toxicities (determine any changes in signs or symptoms that may represent drug toxicity)
Secondary outcome measures
Disease Response
Overall Survival
Progression Free Survival

Side effects data

From 2020 Phase 2 trial • 65 Patients • NCT02085070
83%
Fatigue
62%
Cough
50%
Constipation
50%
Dyspnea
43%
Back pain
40%
Anorexia
36%
Headache
33%
Diarrhea
31%
Pain in extremity
29%
Nausea
24%
Rash maculo-papular
24%
Dizziness
24%
Edema limbs
21%
Anxiety
17%
Insomnia
17%
Hypertension
14%
Abdominal pain
14%
Thromboembolic event
14%
Hypothyroidism
12%
Non-cardiac chest pain
12%
Pruritus
12%
Allergic rhinitis
10%
Vomiting
10%
Pain
10%
Muscle weakness lower limb
10%
Floaters
7%
Gastroesophageal reflux disease
7%
Dyspepsia
7%
Aspartate aminotransferase increased
7%
Fever
7%
Arthralgia
7%
Neck pain
7%
Chest wall pain
7%
Depression
7%
Creatinine increased
7%
Bone pain
7%
Seizure
7%
Alanine aminotransferase increased
5%
Cognitive disturbance
5%
Pneumonitis
5%
Nasal congestion
2%
Chills
2%
Adrenal Insufficienvy
2%
Acute Kidney Injury
2%
Hypokalemia
2%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-small Cell Lung Cancer Patients
Melanoma Patients

Trial Design

1Treatment groups
Experimental Treatment
Group I: MK-3475 + GemcitabineExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-3475
2014
Completed Phase 2
~1340
Gemcitabine
2017
Completed Phase 3
~2070

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve immune checkpoint inhibitors such as Pembrolizumab. Pembrolizumab works by inhibiting the PD-1 receptor, a protein on T cells that normally helps keep these cells from attacking other cells in the body, including cancer cells. By blocking PD-1, Pembrolizumab enhances the immune system's ability to detect and destroy cancer cells. This mechanism is significant for NSCLC patients as it offers a targeted approach to boost the body's natural defenses against cancer, potentially leading to better treatment outcomes and prolonged survival.
Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11).

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
119 Previous Clinical Trials
822,571 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,247 Total Patients Enrolled
Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
18 Previous Clinical Trials
462 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02422381 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: MK-3475 + Gemcitabine
Non-Small Cell Lung Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02422381 — Phase 1 & 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02422381 — Phase 1 & 2
~2 spots leftby Jul 2025