Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06416436
Phase
PHASE1
Status
Withdrawn

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered at a fixed dose of 1680 mg IV route every 4 weeks (1680 mg on Day 1 of each 28-day cycle), which is an approved dosage for atezolizumab, as outlined in the prescribing information.
  • Stereotactic Ablative Radiotherapy (SBRT) — RADIATION
    Ultra-High Doses of Ablative Radiosurgery SBRT is delivered to metastases over 3-5 fractions within 1-2 weeks

Study Details

The purpose of this study is to determine whether cytoreduction of bulky metastatic disease using ultra high dose SBRT in combination with immunotherapy is tolerable and feasible In patients who have exhausted SoC treatment options.

Key Dates

Start date
Jul 15, 2024
Status verified
Jun 2025
Primary completion
Jul 15, 2024
Completion
Jul 15, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SBRT with concurrent and adjuvant atezolizumab immunotherapy

Primary Outcome Measure

Maximum tolerated dose of ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) for 3 different body sites [ Time Frame: 1 Month ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Kansas Medical CenterKansas CityKansas66160-

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