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Monoclonal Antibodies
Immunotherapy + Radiation for Advanced Cancer
Phase 1 & 2
Waitlist Available
Led By James Welsh
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients must have at least one metastatic or primary lesion within the bone, lung/chest, liver or adrenal located in an anatomical location amenable to radiation treatment with either 50 Gy in 4 fractions, 60 Gy in 10 fractions, or 30 Gy in 5 fx. Patients may not have more then 80% liver displaced with cancer
Patients must have histological confirmation of solid metastatic cancer with at least one metastatic or primary lesion in the bone, adrenal, liver or lung/chest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a combination of immunotherapy drugs and radiation to treat patients with metastatic solid malignancies. The goal is to see if this combination can kill more tumor cells with fewer side effects.
Who is the study for?
Adults with metastatic solid cancers, not breastfeeding or donating sperm, and willing to use contraception. They must have normal organ/marrow function, no severe allergies to immunotherapy drugs, and can't be on certain medications. Eligible even if they've had prior cancer treatments (except anti-CTLA4-NF drugs) or controlled autoimmune disorders.Check my eligibility
What is being tested?
The trial is testing a combination of an experimental drug BMS986218 with Nivolumab and precise radiation therapy on patients with metastatic cancers. The goal is to see how well this trio works together in stopping cancer growth by enhancing the body's immune response.See study design
What are the potential side effects?
Potential side effects include typical reactions from immunotherapies such as fatigue, inflammation in organs, allergic reactions, and possibly complications related to pre-existing conditions like autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a cancer lesion in a place suitable for radiation and less than 80% of my liver is affected by cancer.
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My cancer has spread to my bones, adrenal glands, liver, or lungs.
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I am not pregnant and have taken a test to confirm this if I'm able to have children.
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I am 18 years old or older.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am fully active or able to carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Neoplasms
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (BMS-986218, SBRT, nivolumab)Experimental Treatment3 Interventions
Patients receive anti-CTLA4 monoclonal antibody BMS-986218 and SBRT as in Arm 1. Beginning cycle 2, patients also receive nivolumab IV over 30 minutes starting on day 1. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (BMS-986218, SBRT)Experimental Treatment2 Interventions
Patients receive anti-CTLA4 monoclonal antibody BMS-986218 IV over 30 minutes on day 1. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT on days 36-39 (days 8-11 of cycle 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,203 Total Patients Enrolled
James WelshPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
427 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to follow the study's contraception rules or abstain from sex as required.I have brain metastases but no symptoms, and I haven't taken steroids for 2 weeks.I am not on treatments like IL-2, interferon, chemotherapy, or high-dose steroids while receiving BMS-986218.I have had cancer treatment with immunotherapy and my cancer got worse, but it's not required.I have hypothyroidism from an autoimmune condition and take hormone replacement.I do not have any health or mental conditions that could make this study unsafe for me.I agree to use birth control and not donate sperm for up to 7 months after treatment.My cancer has spread to my bones, adrenal glands, liver, or lungs.I have a cancer lesion in a place suitable for radiation and less than 80% of my liver is affected by cancer.You can still join the study if you have asthma that is under control or mild seasonal allergies.I've waited the required time after my last cancer treatment to join this study, except for specific ongoing therapies if I have prostate cancer.I have a stable thyroid condition, with no active autoimmune thyroid disorders.I am HIV positive or have hepatitis B, or I have hepatitis C but with a negative PCR test.I have not had any vaccines except the flu shot in the last month.I am not pregnant and have taken a test to confirm this if I'm able to have children.I have previously been treated with or my condition worsened on an anti-CTLA4-NF drug.My condition is listed as eligible for this trial.I have vitiligo.I have Type 1 diabetes.My total bilirubin levels are within normal range, or I have Gilbert's syndrome with normal direct bilirubin.I have a current diagnosis of diverticulitis or other serious GI conditions.You have a history of a weak immune system or have received treatments that weaken your immune system, as decided by your doctor.I have not had severe, unresolved side effects from previous immuno-oncology drugs.I have or might have an autoimmune disorder.Your body has too few infection-fighting white blood cells.I have had a stem cell or organ transplant from another person.I am 18 years old or older.If you have psoriasis that doesn't need strong medication or won't come back without an outside cause, you can join the trial.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.Your hemoglobin level is at least 9 grams per deciliter.Your platelet count is at least 75,000.My kidney function, measured by creatinine levels or clearance, is within the required range.Your white blood cell count is at least 2500 per microliter.You have enough infection-fighting white blood cells in your body.My doctor may approve repeat radiation on areas previously treated.Your blood test results for AST and ALT should not be more than 2.5 times the normal limit.My organ and bone marrow function is normal without needing growth factors or transfusions.I am fully active or able to carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (BMS-986218, SBRT, nivolumab)
- Group 2: Arm I (BMS-986218, SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the efficacy of Anti-CTLA4 Monoclonal Antibody BMS-986218 been validated through prior experiments?
"Presently, 82 Phase 3 trials are being conducted on Anti-CTLA4 Monoclonal Antibody BMS-986218 with a total of 718 clinical studies ongoing. Most of these research sites are located in Basel, BE; there is also an impressive 40237 locations running tests for Anti-CTLA4 Monoclonal Antibody BMS-986218."
Answered by AI
What medical concerns does Anti-CTLA4 Monoclonal Antibody BMS-986218 usually address?
"BMS-986218, an anti-CTLA4 monoclonal antibody, is utilized to combat malignant neoplasms and other disorders such as inoperable melanoma, squamous cell carcinoma, and metastasized esophageal adenocarcinoma."
Answered by AI
Are there still vacancies for individuals to partake in this research?
"This research project is not taking on new participants at this time. It was initially posted on the 29th of March 2021, and its last update came around November 4th 2022. However, individuals looking for other trials may be interested to know that there are currently 6175 studies recruiting patients with stage iii c lung cancer ajcc v8 and 718 clinical trials seeking out those affected by Anti-CTLA4 Monoclonal Antibody BMS-986218."
Answered by AI
Is this investigation the inaugural effort of its kind?
"Research on Anti-CTLA4 Monoclonal Antibody BMS-986218 commenced in 2012 with a study sponsored by Ono Pharmaceutical Co. Ltd., and after exhibiting positive results, it was approved for Phase 1 & 2 clinical trials. Nowadays, the drug is being studied across 49 countries in 2354 cities with 718 active studies."
Answered by AI
What is the scope of enrollment for this trial?
"Unfortunately, this trial is not currently recruiting. It was initially posted on March 29th 2021 and its most recent update happened November 4th 2022. If you're searching for alternative studies, there are 6175 clinical trials with stage iiic lung cancer ajcc v8 admitting participants at the moment and 718 medical experiments employing Anti-CTLA4 Monoclonal Antibody BMS-986218 accepting patients."
Answered by AI
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