IRB #

STUDY00015662

Title

CA209-451: A Randomized, Multicenter, Double Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (SCLC) after Completion of Platinum-based First Line Chemotherapy

Principal Investigator

Jeremy Cetnar

Study Purpose

To assess the effectiveness, safety, and tolerability of using nivolumab in patients with Small Cell Lung Cancer (SCLC). This study will also compare any good and bad effects of adding a drug called ipilimumab to using nivolumab to see if it improves the survival of patients with SCLC, and if it can delay the progression of lung cancer when compared to placebo.

Medical Condition(s)

Extensive-stage disease Small Cell Lung Cancer (SCLC)

Eligibility Criteria

1. Male or female age 18 or older
2. Confirmed Small Cell Lung Cancer (SCLC)
3. Extensive stage disease (Stage IV)
4. Received one prior chemotherapy for metastatic disease


Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Treatment will continue until your disease progresses, you can’t tolerate the treatment, or you and/or your doctor decide to stop treatment. After that participants will be followed until the end of the study.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
knight@ohsu.edu

Sponsor

Bristol-Myers Squibb

Recruitment End

12/31/2030

Compensation Provided

No


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