Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Study ID
NCT03792724
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • Urelumab + Nivolumab — DRUG
    Treatment with intratumoral urelumab after which Nivolumab will be given.

Study Details

Open label, phase I-II study to evaluate the safety and activity of intratumoral urelumab combined with systemic nivolumab in patients with advanced solid tumors. Serial tumor and blood samples will be obtained during the study to characterize the changes induced by treatment in the tumor microenvironment, as well as predictive biomarkers of response.

Key Dates

Start date
Jan 30, 2019
Status verified
Nov 2018
Primary completion
Jan 30, 2023
Completion
Jan 30, 2023

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Three doses of intratumoral urelumab will be administered, every 4 weeks. after which Nivolumab will be given at a fixed dose of 240 mg for Cycle 2 and at a fixed dose of 480 mg every 4 weeks (Q4W) from Cycle 3 and beyond
  • Experimental: Cohort B
    Three doses of intratumoral urelumab will be administered, every 4 weeks. after which Nivolumab will be given at a fixed dose of 240 mg for Cycle 2 and at a fixed dose of 480 mg Q4W from Cycle 3 and beyond

Primary Outcome Measure

Number of adverse events [ Time Frame: 27 months ]

Central Contacts

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