Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

  • Interventional
  • Recruiting
  • NCT02899299
Eligibility Details Visit Clinicaltrials.gov

A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

        Inclusion Criteria:

         - Males and Females at least 18 years of age

         - Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery

         - ECOG Performance status of 0 or 1

         - Available tumor sample for testing

         - Acceptable blood work

        Exclusion Criteria:

         - Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas

         - Prior chemotherapy for pleural mesothelioma

         - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody

         - History of other malignancy unless the subject has been disease-free for at least 3 years

         - Active, untreated central nervous system (CNS) metastasis

        Other protocol defined inclusion/exclusion criteria could apply

At a Glance

National Government IDNCT02899299

IRB#IRB16-1055

Lead SponsorBristol-Myers Squibb

Lead PhysicianHedy Kindler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting