50 Participants Needed

Immunotherapy + SBRT for Solid Cancers

Recruiting at 1 trial location
AR
JU
Overseen ByJulie Urban, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combining radiation, nivolumab, and BMS-986253 for patients with advanced cancers who haven't responded to other treatments. The goal is to find safe doses and see if this combination can help the immune system fight cancer more effectively. Nivolumab, often combined with ipilimumab, has shown promising results in improving survival rates in various cancers, including melanoma.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on immunosuppressive therapy or have received chemotherapy or immunotherapy recently. It's best to discuss your specific medications with the trial team.

Is the combination of immunotherapy and SBRT generally safe for humans?

Immunotherapy drugs like nivolumab, which are used in combination with other treatments, have been associated with some side effects, including inflammation of the colon (colitis), liver enzyme changes, skin rash, thyroid issues, and lung inflammation. These side effects are generally rare and can often be managed with early intervention.12345

What makes the treatment with BMS-986253 and Nivolumab unique for solid cancers?

This treatment combines immunotherapy with stereotactic body radiotherapy (SBRT), using Nivolumab, a drug that blocks a protein called PD-1 to help the immune system attack cancer cells. This combination is unique because it aims to enhance the body's immune response against cancer by using both a targeted drug and precise radiation therapy.678910

What data supports the effectiveness of the treatment combining immunotherapy and SBRT for solid cancers?

Research suggests that combining stereotactic body radiotherapy (SBRT) with immunotherapy, like nivolumab, can enhance the immune response and improve disease control in patients with certain types of cancer, such as non-small cell lung cancer (NSCLC). This combination has shown potential in improving outcomes for patients with limited metastases, known as oligometastases.79111213

Who Is on the Research Team?

Medical Oncology | Dept of Medicine ...

Jason Luke, MD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors like melanoma or renal cell carcinoma, who have progressed on standard therapies. They must be able to undergo radiation, have normal organ function, and not be pregnant or breastfeeding. Participants need detectable IL-8 levels in their blood and an ECOG performance status of 0 or 1.

Inclusion Criteria

You have a certain level of IL-8 in your blood at the start of the study.
I am using effective birth control if I can have children or am sexually active.
I have 1-4 tumors that can be safely treated with radiation.
See 12 more

Exclusion Criteria

I have specific health conditions or cancers.
You have a current, known, or suspected autoimmune disease.
I have not had chemotherapy, immunotherapy, or radiation recently.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Evaluation of safety and tolerability of different doses of SBRT in combination with nivolumab and BMS-986253 in participants with advanced solid tumors

8 weeks
Every 2 weeks

Treatment Part 2

Assessment of preliminary efficacy of SBRT in combination with nivolumab and BMS-986253 in participants with advanced/metastatic/unresectable melanoma

Up to 1 year
Every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986253
  • Nivolumab
  • Stereotactic Body Radiotherapy (SBRT)
Trial Overview The study tests the safety of combining Stereotactic Body Radiotherapy (SBRT) with two immunotherapy drugs: Nivolumab (anti-PD1) and BMS-986253 (anti-IL-8). It aims to find safe radiation doses by organ site when used with these drugs and observe changes in tumor environments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Nivolumab (Anti-PD-1) + BMS-986253 (Anti-IL-8) + SBRTExperimental Treatment3 Interventions
480 mg intravenous nivolumab (BMS-936558-01) every 4 weeks + 2,400 mg intravenous BMS-986253 (Anti-IL-8) every 2 weeks + Stereotactic Body Radiotherapy (SBRT)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jason J. Luke, MD

Lead Sponsor

Trials
5
Recruited
720+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

In a phase 1 trial involving 37 treatment-naive patients with stage IV NSCLC, combining concurrent stereotactic body radiotherapy (SBRT) with nivolumab and ipilimumab showed no dose-limiting toxicities, indicating a favorable safety profile for this multimodal treatment approach.
The study reported a median progression-free survival of 5.8 months and demonstrated that concurrent therapy was well tolerated, suggesting that this combination could effectively control metastasis in widely metastatic patients.
A Phase 1 Trial of Concurrent or Sequential Ipilimumab, Nivolumab, and Stereotactic Body Radiotherapy in Patients With Stage IV NSCLC Study.Bestvina, CM., Pointer, KB., Karrison, T., et al.[2022]
The addition of stereotactic body radiation therapy (SBRT) to checkpoint inhibitor (CPI) immunotherapy in 35 patients with metastatic non-small cell lung cancer was found to be safe, with no severe radiation-induced toxicities (grade 3 to 5) reported.
The combination treatment resulted in a best systemic objective response rate of 53%, indicating a promising efficacy that supports the need for further randomized trials to explore this approach.
A Prospective Trial Evaluating the Safety and Systemic Response From the Concurrent Use of Radiation Therapy with Checkpoint Inhibitor Immunotherapy in Metastatic Non-Small Cell Lung Cancer.Mattes, MD., Eubank, TD., Almubarak, M., et al.[2022]
In a study of 85 patients with metastatic non-small cell lung cancer (NSCLC) treated with nivolumab, those who received radiotherapy (RT) prior to or during treatment had a significantly longer progression-free survival (PFS) of 2.8 months compared to 1.3 months for those who did not receive RT.
The combination of RT and nivolumab did not increase toxicity, suggesting that RT may enhance the effectiveness of anti-PD-1 therapy without adding adverse effects.
Prior or concurrent radiotherapy and nivolumab immunotherapy in non-small cell lung cancer.Ratnayake, G., Shanker, M., Roberts, K., et al.[2020]

Citations

A Phase 1 Trial of Concurrent or Sequential Ipilimumab, Nivolumab, and Stereotactic Body Radiotherapy in Patients With Stage IV NSCLC Study. [2022]
A Prospective Trial Evaluating the Safety and Systemic Response From the Concurrent Use of Radiation Therapy with Checkpoint Inhibitor Immunotherapy in Metastatic Non-Small Cell Lung Cancer. [2022]
Prior or concurrent radiotherapy and nivolumab immunotherapy in non-small cell lung cancer. [2020]
Oligometastasis and local ablation in the era of systemic targeted and immunotherapy. [2021]
Randomized phase II trial in prostate cancer with hormone-sensitive OligometaSTatic relapse: Combining stereotactic ablative radiotherapy and durvalumab (POSTCARD GETUG P13): Study protocol. [2023]
Safety and activity of ibrutinib in combination with nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukaemia: a phase 1/2a study. [2021]
Comprehensive Meta-analysis of Key Immune-Related Adverse Events from CTLA-4 and PD-1/PD-L1 Inhibitors in Cancer Patients. [2023]
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]
Imaging and clinical manifestations of immune checkpoint inhibitor-related colitis in cancer patients treated with monotherapy or combination therapy. [2021]
Abnormal generation of IL-17A represses tumor infiltration of stem-like exhausted CD8+ T cells to demote the antitumor immunity. [2023]
Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. [2023]
Toll-like receptor 7/8 agonist R848 alters the immune tumor microenvironment and enhances SBRT-induced antitumor efficacy in murine models of pancreatic cancer. [2023]
An update on the pharmacodynamics, pharmacokinetics, safety and clinical efficacy of nivolumab in the treatment of solid cancers. [2018]
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