Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks (up to 2 years)
Awards & highlights
Study 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 belowSelect...
I have advanced non-small cell lung cancer confirmed by a biopsy.
Select...
I have had 1 to 3 treatments for my advanced disease.
Select...
I am capable of becoming pregnant and have a negative pregnancy test.
Select...
My blood tests for organ and marrow function are normal.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 12 weeks (up to 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks (up to 2 years)
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 • NCT0208507083%
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
~1290
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,519 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,555 Total Patients Enrolled
Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
18 Previous Clinical Trials
462 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had lung issues from past radiation that might worsen with new treatment.I have been treated with drugs targeting PD-1, PD-L1, or CTLA4.I have been treated with gemcitabine before.Your disease can be measured using specific criteria called RECIST 1.1.I am currently using steroids, but only in forms that don't affect my whole body.I have advanced non-small cell lung cancer confirmed by a biopsy.I have had 1 to 3 treatments for my advanced disease.Any side effects from my past treatments have mostly gone away.I am capable of becoming pregnant and have a negative pregnancy test.I finished any experimental treatments over 3 weeks ago.My blood tests for organ and marrow function are normal.I completed radiation for symptoms outside my brain or spinal cord over 2 weeks ago.I have an autoimmune disease, but it's either vitiligo or stable hypothyroidism.I have treated brain metastases and no symptoms.The hospital has saved enough tumor tissue for testing.I have no active cancer except for treated skin cancer.I am fully active or restricted in physically strenuous activity but can do light work.You are expected to live for at least 3 more months.I am HIV positive or have Hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: MK-3475 + Gemcitabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has MK-3475 been explored in other scientific experiments?
"Currently, MK-3475 is being studied in 1368 live trials with 244 of them having reached Phase 3. Trials are dispersed across 54125 medical sites throughout the world, though there is a strong focus on Shanghai."
Answered by AI
What is the enrollment size of this clinical investigation?
"At present, this clinical trial is not seeking recruits. The posting was initially published on July 20th 2015 and altered for the last time on September 9th 2022. Notably, there are 1904 distinct trials currently recruiting patients suffering from carcinoma non-small cell lung cancer and 1368 studies searching for individuals in need of MK-3475 intervention."
Answered by AI
To what ailments is MK-3475 commonly prescribed?
"MK-3475 can help treat malignant tumours, unresectable melanoma, and cases where microsatellite instability is high."
Answered by AI
Are enrollments still being accepted for this investigation?
"Presently, this research endeavor is not accepting new participants. It was initially made available on July 20th 2015 and last updated September 9th 2022. If you are seeking alternative trials, there are 1904 investigations actively admitting patients with carcinoma non-small-cell lung cancer in addition to 1368 studies utilizing MK-3475 which have open registrations."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger