Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 29, 2021

Primary Completion Date

May 17, 2024

Study Completion Date

May 31, 2027

Conditions
MelanomaUnresectable Solid TumorsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteAntineoplastic Agents, ImmunologicalAntineoplastic AgentsImmune Checkpoint InhibitorsMolecular Mechanisms of Pharmacological ActionNivolumab
Interventions
DRUG

nivolumab

"Nivolumab (BMS-936558-01), 480 mg intravenous (every 4 weeks)~Treatment must be within 7 days of the last dose of radiation."

DRUG

BMS-986253

"BMS-986253 (Anti-IL-8), 2,400 mg intravenous (every 2 weeks)~Treatment must be within 7 days of the last dose of radiation."

RADIATION

Stereotactic Body Radiotherapy (SBRT)

"Stereotactic Body Radiotherapy (SBRT) (varying doses)~SBRT: Initial Dose fractionation of 3 or 5 fractions of radiation as determined by the location of the metastases to be irradiated, to at least 1 but no more than 4 metastatic lesions. There will be a minimum of 40 hours between treatments for an individual metastasis.~SBRT must be completed within a 14-day window, separate from the screening phase. Treatment with nivolumab and BMS-986253 must be within 7 days of the last dose of radiation."

Trial Locations (2)

15232

RECRUITING

UPMC Hillman Cancer Center, Pittsburgh

60637

RECRUITING

University of Chicago Medical Center, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Yana Najjar

OTHER

NCT04572451 - Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma | Biotech Hunter | Biotech Hunter