Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT02665416
Phase
PHASE1
Status
Completed

Conditions

  • Advanced/Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • Selicrelumab — DRUG
    Selicrelumab will be provided as concentrate for solution to be administered via SC injection
  • Vanucizumab — DRUG
    Vanucizumab will be provided as solution to be administered via IV infusion.
  • Bevacizumab — DRUG
    Bevacizumab will be administered via IV infusion.

Study Details

This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish the maximum tolerated dose (MTD) of Selicrelumab in this combination. Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab in combination with bevacizumab among indication-specific cohorts and to confirm the recommended dose.

Key Dates

First listed
Jan 27, 2016
Start date
Jan 25, 2016
Status verified
Apr 2020
Primary completion
Oct 30, 2019
Completion
Oct 30, 2019

Study Design

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

Arms

  • Experimental: Part I: Selicrelumab, Vanucizumab/Bevacizumab
    Participants will receive a fixed dose of vanucizumab, 2 grams via IV infusion on Days 1 and 15 of every 28-day cycle. Selicrelumab will be given SC in ascending dose levels on Day 2 of Cycles 1 to 4 and every third cycle thereafter. Treatment will continue as long as the participant experiences clinical benefit or until unacceptable toxicity, withdrawal of consent, or the end of Part I of the study (expected 24 months). Due to the discontinuation of Vanucizumab development, Participants ongoing in Part I will switch from Vanucizumab to Bevacizumab. All the dose escalation has been performed using Vanucizumab.
  • Experimental: Part II: Selicrelumab, Bevacizumab
    Bevacizumab will be administered via IV infusion on days 1 and 15 of every 28-day cycle. Selicrelumab will be given SC after the Bevacizumab infusion at the dose determined in the Part I of the study on Day 2 of Cycles 1 to 4 and every third cycle thereafter. Treatment will continue as long as the participant experiences clinical benefit or until unacceptable toxicity, withdrawal of consent, or the end of Part II of the study (expected 18 months).

Primary Outcome Measure

Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Baseline until Participant's discontinuation or death, whichever occurs first, as per schedule in the description (up to approximately 42 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Univ of CO Health Science CtrDenverColorado80262-
Yale Cancer Center; Medical OncologyNew HavenConnecticut06520-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CAUniv of CO Health Science Ctr· Denver, COYale Cancer Center; Medical Oncology· New Haven, CTDana Farber Cancer Institute· Boston, MAUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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