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Monoclonal Antibodies
Immunotherapy + Radiation for Advanced Lung or Liver 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
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%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer has spread to my liver or lungs, confirmed by a biopsy.
Select...
I have a cancer lesion in my lung/chest or liver that can be treated with SBRT.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
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
Ipilimumab
FDA approved
Nivolumab
FDA approved
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,440 Total Patients Enrolled
James WelshPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
452 Total Patients Enrolled
Joe ChangPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
What are the chief aims of this experiment?
"The primary objective of the study, assessed for up to a year, is examining adverse events related with nivolumab alongside BMS-986156 and SBRT targeting lung lesions. Additionally, secondary objectives include evaluating if skeletal mass, neutrophil count and ratio, and tumor bulk are linked to clinical outcomes or adverse events via qualitative correlations; exploring how tumor kinetics in combination with other data can be used to determine treatment response through mathematical modelling; as well as determining whether increased tumour mutational burden leads to improved clinical responses."
Answered by AI
What is the highest number of participants this experiment can accommodate?
"Affirmative. The information on clinicaltrials.gov states that the medical trial, which was first posted 19th August 2019, is actively recruiting. Approximately 60 participants must be recruited from one location."
Answered by AI
Are there any other empirical investigations that have utilized Ipilimumab?
"Currently, 765 clinical studies seeking to evaluate Ipilimumab are underway. Of those trials, 86 have entered Phase 3 and many of these are situated in Pittsburgh, Pennsylvania. Globally there are 42707 sites conducting research for this treatment option."
Answered by AI
Are there any patient slots left available to participate in this trial?
"Correct. Clinicaltrials.gov data indicates that this clinical trial, which was launched on August 19th 2019, is presently running and looking for applicants. Approximately 60 participants are needed from a single centre."
Answered by AI
What pathologies has Ipilimumab been found to be an efficacious treatment for?
"Ipilimumab can be a viable option for treating prior anti-angiogenic therapy, malignant neoplasms, and inoperable melanoma."
Answered by AI
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