Study Evaluating CMP-001 in Combination With Atezolizumab in Participants With Non-Small Cell Lung Cancer

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03438318
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • CMP-001 — DRUG
    CMP-001 will be administered as per the dose and schedule specified in the respective arms.
  • Atezolizumab — DRUG
    Atezolizumab will be administered as per the approved label and according to the schedule specified in the respective arms.
  • Radiation Therapy — RADIATION
    Radiation therapy will be administered using either 3-dimensional (3D) conformal radiotherapy or intensity-modulated radiation therapy (IMRT) to non-target node or metastatic lesion as per the dose and schedule specified in the respective arms.

Study Details

This is a multicenter, two part (Part A and Part B) clinical study of CMP-001 administered intratumorally (IT) and subcutaneously (SC) in combination with atezolizumab with or without radiation therapy in participants with NSCLC.

Key Dates

Start date
Mar 15, 2018
Status verified
Aug 2022
Primary completion
Dec 11, 2019
Completion
Dec 11, 2019

Study Design

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

Arms

  • Experimental: Part A (CMP-001, Atezolizumab and Optional Radiation Therapy)
    Participants will receive CMP-001 5 milligrams (mg) SC once weekly for 2 weeks, then 10 mg IT once weekly for 3 weeks, followed by every 3 weeks thereafter until discontinuation of treatment in combination with atezolizumab SC every 3 weeks starting at Week 2. Route of administration (IT/SC) for CMP-001 beyond Week 5 will be determined by Investigator. Participants enrolled in Part A who progressed per RECIST v1.1 on combination of CMP-001 and atezolizumab have opportunity to enroll in Part A optional radiation therapy add-on after documented disease progression per CT/MRI or PET scan. After CMP-001 washout period of 10 days, participants will be treated with radiation consisting of 20 grays in 5 fractions for 5 days then resume CMP-001 treatment.
  • Experimental: Part B (Radiation Therapy, CMP-001 and Atezolizumab)
    Participants will be treated with radiation therapy consisting of 20 grays in 5 fractions for 5 days, then participants will receive CMP-001 5 mg SC once weekly for 2 weeks, then 10 mg IT once weekly for 3 weeks, followed by dosing every 3 weeks thereafter until discontinuation of treatment. The route of administration (that is, IT or SC) for CMP-001 beyond Week 5 will be determined by the Investigator. First dose of CMP-001 will be administered within 2 days of radiation therapy. Atezolizumab will be administered SC in combination with CMP-001 every 3 weeks starting at Week 2.

Primary Outcome Measure

Part A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (up to approximately 2 years 9 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
City of Hope Medical CenterDuarteCalifornia91010-
University of Colorado AuroraAuroraColorado80045-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
MD AndersonHoustonTexas77030-

Find similar trials in Gilbert, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Banner MD Anderson Cancer Center· Gilbert, AZCity of Hope Medical Center· Duarte, CAUniversity of Colorado Aurora· Aurora, COUniversity of Iowa Hospitals and Clinics· Iowa City, IAMD Anderson· Houston, TX

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