RecruitingPhase 1NCT04572451

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

Phase I Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma

Sponsor

Yana Najjar

Enrollment

50 participants

Start Date

Nov 29, 2021

Study Type

INTERVENTIONAL

Conditions

Melanoma Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immune Checkpoint Inhibitors Neoplasms by Histologic Type Unresectable Solid Tumors Antineoplastic Agents, Immunological Nivolumab

Summary

Nivolumab (and other agents affecting the anti-programmed death-1 \[anti-PD-1\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance. In this phase I/Ib study, radiation will be used in combination with IO agents nivolumab and anti-IL-8 (BMS-986253) to assess toxicity by organ system and then assess the preliminary efficacy of the treatment regimen. In Part 1, the study will determine the safe doses of radiation by organ site in conjunction with nivolumab and BMS-986253. In Part 2, the treatment regimen will be investigated in melanoma, prioritizing acral melanoma, to describe the response rate to treatment as well as other clinical and safety outcomes. The study will also provide the opportunity to evaluate changes in the tumor microenvironment induced by the treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of targeted radiation (SBRT) with two immunotherapy drugs — an anti-PD-1 drug (nivolumab) and an anti-IL-8 drug — for people with advanced cancers including melanoma and kidney cancer. The goal is to see whether combining radiation with these drugs is safe and can help shrink tumors. **You may be eligible if...** - You are 18 years old or older - You have advanced or metastatic cancer that has progressed after standard treatments - You have 1–4 tumor sites that can safely receive radiation - You are in good general health (ECOG performance status 0 or 1) - Your blood counts, liver, and kidney function are within acceptable ranges - You have at least one measurable tumor **You may NOT be eligible if...** - You have an autoimmune disease that required treatment in the past 2 years - You are on systemic steroids or other immune-suppressing medications - You have active brain metastases - You are pregnant or breastfeeding - You have had a prior severe reaction to immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGnivolumab

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

DRUGBMS-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.

RADIATIONStereotactic 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.