Ipilimumab and Nivolumab in Recurrent Extensive Stage Small Cell Lung Cancer After Receiving Platinum-based Chemotherapy

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT03670056
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Combination immunotherapy with Ipilimumab and Nivolumab — DRUG
    Patients will be treated with nivolumab 1 mg/kg and ipilimumab 3 mg/kg, starting on Day 1. Patients will receive 4 doses of each nivolumab and ipilimumab and then will receive nivolumab 240 mg starting week 13 (day 85) every 2 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.

Study Details

This is a pilot study of patients who previously received platinum chemotherapy with recurrent SCLC to evaluate the change in the ratio of intratumoral Teff/Treg cells and clinical benefit of treatment with nivolumab and ipilimumab.

Key Dates

Start date
Dec 6, 2018
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Ipilimumab
    Patients will be treated with nivolumab 1 mg/kg and ipilimumab 3 mg/kg, starting on Day 1. Patients will receive 4 doses of each nivolumab and ipilimumab and then will receive nivolumab 240 mg starting week 13 (day 85) every 2 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.

Primary Outcome Measure

Change in the ratio of Teff/Treg cells [ Time Frame: Up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University, Yale Cancer CenterNew HavenConnecticut06510-

Find similar trials in New Haven, CT

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Yale University, Yale Cancer Center· New Haven, CT

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