Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT02259621
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Anti-PD-1 Therapy
  • Carboplatin — DRUG
    Anti-PD-1 Therapy
  • Paclitaxel — DRUG
    Anti-PD-1 Therapy
  • Ipilimumab — DRUG
    Anti-PD-1 Therapy

Study Details

The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.

Key Dates

Start date
Sep 30, 2014
Status verified
Nov 2025
Primary completion
Oct 14, 2022
Completion
Oct 31, 2027

Study Design

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

Arms

  • Experimental: Arm B- Nivolumab
    Nivolumab administration: Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days.
  • Experimental: Arm C- Nivolumab, Carboplatin, & Paclitaxel
    Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0.
  • Experimental: Arm A- Nivolumab and Ipilimumab
    One dose of Nivolumab 3mg/kg IV \& Ipilimumab 1mg/kg will be administered to enrolled patients on Day-42, then 2 doses of Nivolumab 3mg/kg will be administered to enrolled patients on Day-28 and Day-14

Primary Outcome Measure

Safety as Measured by Number of Participants With Grade 3 and 4 Lab Abnormalities, as Defined by CTCAE v4.03 [ Time Frame: 8 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Johns Hopkins at Bayview Medical CenterBaltimoreMaryland21224-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-
Memorial Sloan KetteringNew YorkNew York10065-
Swedish Cancer InsituteEdmondsWashington98026-

Find similar trials in Baltimore, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Johns Hopkins at Bayview Medical Center· Baltimore, MDSidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDMemorial Sloan Kettering· New York, NYSwedish Cancer Insitute· Edmonds, WA

Related Studies