Merck: Clinical Trials | A Phase 3, Randomized, Double-Blind Study of Pembrolizumab plus Ipilimumab vs Pembrolizumab plus Placebo in Previously Untreated | 3475-598

A Phase III, Randomized, Double-Blind Study of Pembrolizumab plus Ipilimumab vs Pembrolizumab plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors are PD-L1 Positive (TPS ≥ 50%) (MK-3475-598)

At a Glance

This clinical research study will evaluate how well an immunotherapy called pembrolizumab works when combined with a second immunotherapy called ipilimumab. Ipilimumab is not currently FDA approved to treat non-small cell lung cancer and the combination of these two immunotherapies is investigational. This study is also researching how safe it is to use both drugs at the same time.

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  • Condition: Non-small Cell Lung Cancer (NSCLC)
  • Study Treatment/Method (drugs): Ipilimumab or placebo in combination with pembrolizumab
    • Phase: III
    • Enrollment Goal: 548
  • Possibility of treatment with pembrolizumab:
  • Possibility of treatment with ipilimumab:

Important Information to Consider

There's a lot to think about when considering whether to volunteer for a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before deciding to participate.

Also, this is not a complete overview of study criteria. A study doctor will review your information to see if you qualify.

To learn more about how clinical studies work, visit the Patients & Caregiver section of the Merck Clinical Trials site, as well as our frequently asked questions.

Clinical Study Approach

Investigational Drug

WHAT WE'LL NEED FROM PARTICIPANTS:

A new sample of your tissue from any tumor site and blood test

A new or archived sample of tissue from any tumor site plus blood and urine tests

Radiographic imaging every 9 to 12 weeks

Study visits every 3 weeks

  • Other requirements as decided by the study doctor.

The Study Drug

The study drugs, pembrolizumab and ipilmumab, have been FDA-approved for use in certain types of cancer but ipilimumab is not currently FDA approved to treat non-small cell lung cancer. The combination of these two immunotherapies is investigational.

Participation & Eligibility

Age 50 to 85
Genders: Male

DURATION & REQUIREMENTS SUMMARY

You must have a diagnosis of non-small cell lung cancer. The study will last approximately 3 years.

 

Learn More

Study Locations

We are planning on conducting this study in the United States and/or Canada.

Find a Study Location

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