Immunotherapy + Radiation for Advanced Lung or Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of treatments to evaluate their effectiveness for individuals with lung, chest, or liver cancer that has metastasized. It tests new medications called monoclonal antibodies, including BMS-986156, Ipilimumab, and Nivolumab, which may help the immune system fight cancer. These may be combined with a precise form of radiation therapy known as Stereotactic Body Radiation Therapy. Individuals with metastatic lung, chest, or liver cancer who have already tried other treatments might be suitable candidates. The trial aims to determine the best dose, understand any side effects, and assess whether the treatments can halt cancer growth or spread. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Do I need to stop my current medications for the trial?
The trial requires that you stop any prior systemic anti-cancer therapies for a period of 5 drug half-lives or 4 weeks, whichever is shorter, before enrolling. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of BMS-986156, ipilimumab, and nivolumab is generally well-tolerated by patients. These immunotherapy drugs, when used together, have produced promising results for individuals with advanced cancers. Specifically, BMS-986156, combined with ipilimumab and nivolumab, has been well-tolerated, with many patients experiencing positive outcomes in trials.
One study found that this combination was well-received even when used with stereotactic body radiation therapy (SBRT). This suggests that the treatment remains manageable for patients, even with added radiation. While side effects can occur, as with any treatment, these drugs have demonstrated a safety profile in other trials that supports further research.
It is important to note that BMS-986156 is still under study and has not yet received FDA approval for general use. However, ipilimumab and nivolumab are approved for other conditions, indicating a certain level of safety. Participating in a clinical trial can help provide more information about how these treatments work together and their side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine immunotherapy with radiation in a novel way to tackle advanced lung or liver cancer. Unlike traditional chemotherapy or standalone immunotherapy, this approach uses a combination of drugs like ipilimumab, nivolumab, and the novel anti-GITR agonistic monoclonal antibody BMS-986156, which work together to enhance the immune system's ability to fight cancer. Additionally, some treatment arms incorporate SBRT (stereotactic body radiation therapy), delivering high doses of radiation precisely to the tumor. This combination aims to boost the effectiveness of immunotherapy and potentially lead to better outcomes with fewer side effects than conventional treatments.
What evidence suggests that this trial's treatments could be effective for advanced lung or liver cancer?
Research shows that combining the drug BMS-986156 with ipilimumab and nivolumab may help the immune system attack cancer cells. In this trial, participants in Group I will receive ipilimumab, BMS-986156, and nivolumab. Studies have found that using ipilimumab and nivolumab together can help patients with certain advanced cancers, like liver and lung cancer, live longer compared to standard treatments. Participants in Group II will receive ipilimumab, BMS-986156, and nivolumab, along with stereotactic body radiation therapy (SBRT), which precisely targets tumors and may enhance treatment effectiveness by killing more cancer cells with fewer side effects. Group III participants will receive nivolumab, BMS-986156, and SBRT. Early studies suggest that BMS-986156, when used with these drugs, may further enhance the body's ability to fight cancer. Overall, these combination therapies are generally well-tolerated and have shown promising results in patients.36789
Who Is on the Research Team?
Joe Y Chang, MD,MS,PHD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic lung/chest or liver cancers. Participants must have completed previous cancer therapies, be in stable condition (ECOG <=2), and have acceptable organ function. Those with certain brain metastases can join if symptom-free without needing high-dose steroids. Pregnant women, individuals with serious autoimmune diseases, uncontrolled illnesses, recent surgeries, active infections like HIV or hepatitis B/C are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive ipilimumab and BMS-986156 with or without SBRT, followed by nivolumab in later cycles
Radiation
Patients undergo stereotactic body radiation therapy (SBRT) targeting 1-4 lesions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986156
- Ipilimumab
- Nivolumab
- Stereotactic Body Radiation Therapy
Trial Overview
The study tests the combination of immunotherapy drugs BMS-986156, Ipilimumab, Nivolumab and possibly Stereotactic Body Radiation Therapy (SBRT). It aims to find the best dose of BMS-986156 and see how well these treatments work together against lung/chest or liver cancers by enhancing the body's immune response to attack cancer cells.
How Is the Trial Designed?
Patients receive nivolumab IV over 30 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 over 60 minutes on day 1. Patients also undergo SBRT over 30-45 minutes on days 1-4 for 4 fractions or on days 1-12 for 10 fractions. Treatment repeats every 28 days for up to 26 cycles of nivolumab and for up to 4 cycles of anti-GITR agonistic monoclonal antibody BMS-986156 in the absence of disease progression or unacceptable toxicity.
Patients receive ipilimumab IV over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 2, patients then undergo SBRT on days 29-32 for 4 fractions or on days 29-40 for 10 fractions. Beginning day 1 of cycle 5 (day 85), patents receive nivolumab IV over 30 minutes. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive ipilimumab IV over 90 minutes and anti-GITR agonistic monoclonal antibody BMS-986156 IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 1 of cycle 5 (day 85), patients receive nivolumab IV over 30 minutes. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Phase I/II study of BMS-986156 with ipilimumab or nivolumab ...
Herein we describe the results of the safety and efficacy of BMS-986156+ipilimumab or nivolumab with/without stereotactic ablative radiotherapy ...
Study Details | NCT04021043 | BMS-986156, Ipilimumab, ...
Immunotherapy with monoclonal antibodies, such as BMS-986156, ipilimumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere ...
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Efficacy ...
Five-year survival outcomes with nivolumab plus ipilimumab versus chemotherapy as first-line treatment for metastatic non-small cell lung cancer in CheckMate ...
Clinical trial results for previously untreated advanced liver ...
42% of those given OPDIVO® + YERVOY® for untreated advanced HCC survived longer. People given OPDIVO + YERVOY lived longer compared to targeted therapies ...
Bristol Myers Squibb Announces Opdivo (nivolumab) Plus ...
Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population.
Phase I/II study of BMS-986156 with ipilimumab or ...
BMS-986156 was well-tolerated with ipilimumab, nivolumab, with or without SABR. Outcomes were encouraging in this population, ...
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Safety ...
Five-year survival outcomes with nivolumab plus ipilimumab versus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer in Checkmate ...
Phase I/II study of BMS-986156 with ipilimumab or ...
BMS-986156 was well-tolerated with ipilimumab, nivolumab, with or without SABR. Outcomes were encouraging in this population, as more than half of patients had ...
Clinical trial results for advanced liver cancer
See how OPDIVO® (nivolumab) + YERVOY® (ipilimumab) performed in a clinical trial as a treatment for people with liver cancer (hepatocellular carcinoma) ...
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