Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03377023
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Intravenous nivolumab every 2 weeks.
  • Ipilimumab — DRUG
    Intravenous ipilimumab every 6 weeks.
  • Nintedanib — DRUG
    Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.

Study Details

The main purpose of this study is to see if the combination of nivolumab, ipilimumab and nintedanib is effective in people with non- small cell lung cancer. Researchers also want to find out if the combination of nivolumab, ipilimumab and nintedanib is safe and tolerable.

Key Dates

Start date
Feb 2, 2018
Status verified
Mar 2026
Primary completion
Nov 28, 2023
Completion
Aug 31, 2026

Study Design

Enrollment
66 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Nintedanib Dose Escalation 100-200 mg QD to BID
    Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given the following: Nivolumab: 3 mg/kg IV Q2 weeks. Ipilimumab: 1 mg/kg Q6 weeks. Nintedanib Level -1: 100 mg by mouth (PO) once a day (QD) Days 1-14 (Daily dose =100 mg). Nintedanib Level 0:150 mg by mouth (PO) once a day (QD) Days 1-14 (Daily dose =150 mg) Nintedanib Level 1: 100 mg PO twice daily (BID) Days 2-28 (Daily dose = 200 mg). Nintedanib Level 2: 150 mg PO BID Days 1-14 (Daily dose = 300 mg). Nintedanib Level 3: 200 mg PO BID Days 1-14 (Daily dose = 400 mg).
  • Active Comparator: Phase 2 - Arm A Nintedanib 100-200 mg BID Treatment-naïve
    Arm A: Treatment-naïve defined as newly diagnosed or treatment-naïve patients, with a target overall response rate (ORR) of 50%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.
  • Active Comparator: Phase 2 - Arm B Nintedanib 100-200 mg BID Treatment Non-naïve
    Arm B: Treatment Non-naïve defined as patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.

Primary Outcome Measure

Phase 1 - Maximum Tolerated Dose (MTD) [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Related coverage on Hipa.ai

Find similar trials in Tampa, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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