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Monoclonal Antibodies
Immunotherapy + Radiation for Advanced Lung or Liver Cancer
Phase 1 & 2
Waitlist Available
Led By Joe Chang
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
Patients that have previously progressed on immunotherapy such as ipilimumab, anti-PD-I, anti-PDL-1 or talimogene laherparepvec (T-VEC) will be eligible.
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky > 60%)
Must not have
Patients who were intolerant to previous immuno-oncology (IO) drugs should be excluded
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing the side effects and best dose of an immunotherapy drug when given with another immunotherapy drug and/or radiation therapy. The immunotherapy drugs may help the body's immune system attack the cancer, and the radiation therapy may kill cancer cells.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions related to stimulating the immune system such as fatigue, diarrhea, skin issues and inflammation across various organs. SBRT may cause localized pain or skin changes where radiation is delivered. The severity of side effects varies among patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had cancer treatment before with immunotherapy and my cancer still got worse.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer has spread to my liver or lungs, confirmed by a biopsy.
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I have a cancer lesion in my lung/chest or liver that can be treated with SBRT.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a bad reaction to previous immunotherapy treatments.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I have had a stem cell transplant from a donor.
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My HIV, hepatitis B, or hepatitis C is not stable.
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I have a current diagnosis of diverticulitis or other serious GI conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events of ipilimumab with BMS-986156 and SBRT targeting lung lesions
Incidence of adverse events of ipilimumab with anti-GITR agonistic monoclonal antibody BMS-986156 (BMS-986156) and stereotactic body radiation therapy (SBRT) targeting liver lesions
Incidence of adverse events of nivolumab with BMS-986156 and SBRT targeting liver lesions
+2 moreSecondary study objectives
Adverse events will be evaluated using skeletal mass, neutrophil, neutrophil to lymphocyte ratio, and tumor bulk.
Predictive potential value of tumor-associated and systemic immune biomarkers
Progression of non-irradiated tumors
+4 moreSide effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group III (nivolumab, BMS-986156, SBRT)Experimental Treatment3 Interventions
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.
Group II: Group II (ipilimumab, BMS-986156, SBRT, nivolumab)Experimental Treatment4 Interventions
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.
Group III: Group I (ipilimumab, BMS-986156, nivolumab)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Ipilimumab
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,177 Total Patients Enrolled
Joe ChangPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
James WelshPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
452 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've waited the required time after my last cancer treatment to join this study.My liver function tests are within normal limits without needing treatments to achieve this.I do not have any health or mental conditions that could make the study unsafe for me.I have not had a bad reaction to previous immunotherapy treatments.I have had cancer treatment before with immunotherapy and my cancer still got worse.My platelet count is at least 75,000 without recent medical help.I am not pregnant or planning to become pregnant/breastfeed during and after the study. I agree to follow strict birth control measures.My doctor may allow me to have radiation again in areas previously treated.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am not on treatments like IL-2, interferon, chemotherapy, or high-dose steroids while receiving ipilimumab.I have had a stem cell transplant from a donor.I can take care of myself but might not be able to do heavy physical work.My cancer has spread to my liver or lungs, confirmed by a biopsy.I have a cancer lesion in my lung/chest or liver that can be treated with SBRT.My hemoglobin level is at least 9 g/dL without recent transfusions or growth factors.My total bilirubin level is 2.0 mg/dL or less, and I don't have Gilbert's syndrome.My HIV, hepatitis B, or hepatitis C is not stable.My creatinine levels are within twice the normal upper limit without using growth factors or transfusions in the last 2 weeks.My white blood cell count is high enough without recent medical help.I have a current diagnosis of diverticulitis or other serious GI conditions.I haven't had vaccines for infectious diseases a month before or after ipilimumab.I have brain metastases but no symptoms, and I haven't taken high doses of steroids recently.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (ipilimumab, BMS-986156, nivolumab)
- Group 2: Group II (ipilimumab, BMS-986156, SBRT, nivolumab)
- Group 3: Group III (nivolumab, BMS-986156, SBRT)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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