A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma
Part of paid clinical trials in Basking Ridge, New Jersey.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT04162015
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Malignant Pleural Mesothelioma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGnivolumab 360 mg
- Pemetrexed — DRUG500 mg/m\^2
- Cisplatin or Carboplatin — DRUGcisplatin 75 mg/m2 or carboplatin AUC=5
Study Details
This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.
Key Dates
- Start date
- Nov 12, 2019
- Status verified
- Sep 2025
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 22 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: nivolumab with pemetrexed and cisplatin or carboplatinEligible patients will receive two cycles of neoadjuvant therapy with nivolumab 360 mg, pemetrexed 500 mg/m2, and cisplatin 75 mg/m2 or carboplatin AUC=5. Subsequently, they will undergo pleurectomy/decortication.
Primary Outcome Measure
number of patients going to operating room for surgical resection [ Time Frame: 30 days of the initially planned date ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memoiral Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | - |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | - |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | - |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | - |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | - |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | - |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | - |
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