Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03918252
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab Injection — DRUG
    Receive preoperative nivolumab, 240mg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
  • Ipilimumab Injection — DRUG
    Receive preoperative nivolumab, 3mg/kg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) + ipilimumab 1mg/kg IV on Day -42 prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).

Study Details

The proposed study will evaluate the safety and feasibility of neoadjuvant nivolumab +/- ipilimumab in resectable MPM. In addition, maintenance nivolumab will be administered for 1 year following completion of standard bi-/tri-modality therapy.

Key Dates

Start date
Oct 2, 2019
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A Nivolumab Only
    Receive preoperative nivolumab, 240mg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
  • Experimental: Arm B Nivolumab + Ipilimumab
    Receive preoperative nivolumab, 3mg/kg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) + ipilimumab 1mg/kg IV on Day -42 prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).

Primary Outcome Measure

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 [ Time Frame: up to 5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Greenebaum Comprehensive Cancer Center University of Maryland School of MedicineBaltimoreMaryland21201-
Johns Hopkins UniversityBaltimoreMaryland21287-
University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Baltimore, MD

By research site
Greenebaum Comprehensive Cancer Center University of Maryland School of Medicine· Baltimore, MDJohns Hopkins University· Baltimore, MDUniversity of Texas M.D. Anderson Cancer Center· Houston, TX

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