A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Hoffmann-La Roche
Study ID
NCT02350673
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Participants will receive atezolizumab IV infusion at doses of 800 mg q2w or 1200 mg q3w.
  • Cergutuzumab Amunaleukin — DRUG
    Participants will receive cergutuzumab amunaleukin IV infusion at escalated doses and at different dosing schedules in Part I and at MTD (or recommended dose) in Part II.

Study Details

This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the standard of care therapy. Enrolled participants who continue treatment will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest a benefit.

Key Dates

Start date
Jun 29, 2015
Status verified
Jan 2020
Primary completion
Dec 16, 2019
Completion
Dec 16, 2019

Study Design

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

Arms

  • Experimental: Cergutuzumab+Atezolizumab (Part I)
    Participants will receive escalated IV doses of cergutuzumab amunaleukin in combination with atezolizumab. This is a Part I dose escalation phase of the study. Cergutuzumab amunaleukin will be escalated from a starting dose of 6 milligrams (mg) and dosing schedules of every week (qw) and every 2 weeks (q2w) may be explored. Atezolizumab will be administered in fixed flat doses of either 840 mg q2w or 1200 mg every 3 weeks (q3w). Treatment will be continued until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent for a maximum treatment period of 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest longer treatment period is needed.
  • Experimental: Cergutuzumab +Atezolizumab (Part II)
    This is a Part II expansion phase of the study. Participants will receive cergutuzumab amunaleukin at maximum tolerated dose (MTD) (or recommended dose) identified during Part I in combination with atezolizumab. Treatment will be continued until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent for a maximum treatment period of 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest longer treatment period is needed.

Primary Outcome Measure

Number of Participants with Dose-Limiting Toxicities [ Time Frame: Day 1 up to Day 21 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Yale Cancer Center; Medical OncologyNew HavenConnecticut06520-
Columbia Univ Med CtrNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
SCRI-Tennessee OncologyNashvilleTennessee37203-

Find similar trials in New Haven, CT

By research site
Yale Cancer Center; Medical Oncology· New Haven, CTColumbia Univ Med Ctr· New York, NYMemorial Sloan Kettering Cancer Center· New York, NYSCRI-Tennessee Oncology· Nashville, TN

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