Study Summary
This trial will test a new cancer treatment involving two immunotherapy drugs given before surgery, and one drug given for a year after surgery.
Eligible Conditions
- Mesothelioma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: 5 years
5 years
Pathological Response to neoadjuvant nivolumab +/- ipilimumab in resected tumor and lymph nodes in patients with resectable MPM defined as ≤10% residual viable tumor cells and pathologic complete response
Radiographic Response to neoadjuvant nivolumab +/- ipilimumab utilizing RECIST 1.1
Day 100
Toxicity as assessed by number of participants experienced grade III/IV adverse events as defined by CTCAE v5.0 within 100 days of last study drug administration
up to 5 years
Feasibility of neoadjuvant nivolumab +/- ipilimumab in patients with resectable MPM who complete of neoadjuvant treatment and proceed to surgery
Safety Profile of neoadjuvant nivolumab +/- ipilimumab in patients with resectable malignant pleural mesothelioma (MPM) with grade III/IV adverse events defined by CTCAE v5.0
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Arm B Nivolumab + Ipilimumab
1 of 2
Arm A Nivolumab Only
1 of 2
Experimental Treatment
30 Total Participants · 2 Treatment Groups
Primary Treatment: Nivolumab Injection · No Placebo Group · Phase 1 & 2
Arm B Nivolumab + IpilimumabExperimental Group · 2 Interventions: Nivolumab Injection, Ipilimumab Injection · Intervention Types: Drug, Drug
Arm A Nivolumab Only
Drug
Experimental Group · 1 Intervention: Nivolumab Injection · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,501 Previous Clinical Trials
3,928,204 Total Patients Enrolled
14 Trials studying Mesothelioma
2,067 Patients Enrolled for Mesothelioma
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
536 Previous Clinical Trials
31,235 Total Patients Enrolled
Patrick Forde, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4 Previous Clinical Trials
589 Total Patients Enrolled
2 Trials studying Mesothelioma
535 Patients Enrolled for Mesothelioma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Specimens must be reviewed by faculty pathologist at SKCC, MDACC, or UMGCCC.
References
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