Ipilimumab for Metastatic Carcinoma in the Liver

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Metastatic Carcinoma in the Liver+6 More
Ipilimumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of immunotherapy and radiation therapy may be effective in treating patients with cancer.

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Eligible Conditions

  • Metastatic Carcinoma in the Liver
  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Thoracic Cavity
  • Metastatic Carcinoma in the Lung

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Ipilimumab will improve 5 primary outcomes and 7 secondary outcomes in patients with Metastatic Carcinoma in the Liver. Measurement will happen over the course of Up to 29 days for groups 1 and 3, up to day 43 for group 2.

Up to 1 year
Adverse events will be evaluated using skeletal mass, neutrophil, neutrophil to lymphocyte ratio, and tumor bulk.
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
Incidence of adverse events of nivolumab with BMS-986156 and SBRT targeting lung lesions
Predictive potential value of tumor-associated and systemic immune biomarkers
Progression of non-irradiated tumors
Response of non-irradiated tumors
Treatment Success Defined by Immune-related Responses
Treatment response
Tumor mutational burden
Day 43
Incidence of dose-limiting toxicities (DLT)

Trial Safety

Trial Design

3 Treatment Groups

Group I (ipilimumab, BMS-986156, nivolumab)
1 of 3
Group III (nivolumab, BMS-986156, SBRT)
1 of 3
Group II (ipilimumab, BMS-986156, SBRT, nivolumab)
1 of 3
Experimental Treatment

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Ipilimumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Group I (ipilimumab, BMS-986156, nivolumab)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.
Group III (nivolumab, BMS-986156, SBRT)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 (ipilimumab, BMS-986156, SBRT, nivolumab)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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~590

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 year for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have histological confirmation of solid metastatic cancer with at least one metastatic or primary lesion in the liver or lung/chest, except for group 1.
Patients who have completed prior systemic anti-cancer therapies, an interval of 5 drug half-lives or 4-weeks whichever is shorter, is required, prior to enrollment on study. Note: patients with anaplastic thyroid will be waived from this inclusion criteria given the rapid trajectory of their disease
All patients must have at least one metastatic or primary lesion within the lung/chest or liver located in an anatomical location amenable to SBRT treatment with 50 Gy in 4 fractions or with 60 Gy in 10 fractions, except for group 1.
Repeat radiation in fields previously radiated will be allowed at the discretion of the treating physician
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky > 60%)
Total bilirubin =< 2.0 mg/dL (does NOT apply to patients with Gilbert's syndrome) (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
White blood count (WBC) >= 2500/uL (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
Absolute neutrophil count (ANC) >= 1000/uL (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)
Platelets >= 75K (use of growth factors or blood transfusion to achieve these requirements is not allowed 2 weeks prior to study enrollment)

Patient Q&A Section

What are common treatments for cancer?

"The majority of people with cancer are treated by a team of professionals including nurses, surgeons, and oncologists. Many patients have to endure the discomfort of chemotherapy, radiotherapy, pain and other side-effects. Many more cases of cancer can be prevented by making changes to lifestyle. Tobacco smoking is a significant cause of lung cancer. Although most people have access to smoking cessation support from a nurse, a more effective and less stigmatizing support might help smokers, as well as those with cancer, manage and cope with their disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Many of the following symptoms are not related to cancer itself but to the treatment or other medical conditions a person has that might mimic certain signs of cancer." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"Various genetic factors and environmental hazards appear to converge to increase the odds of developing cancer, probably as a result of multiple genomic aberrations or epigenetic alterations." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Around 703,500 new cancer cases occur each year in the United States, including 355,600 cases of cervical cancer and 258,100 of breast cancer. The annual number of cases of colon cancer, cancer of the stomach, and cancer of the pancreas is about 70,500; of oral cancer is about 34,000. Lung cancer, kidney cancer, and brain cancer comprise about 36,500 new cases each year. A few important differences have been observed in the rates of cancer in different racial groups and between men and women." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"Treatment with systemic chemotherapy in patients with colorectal cancer is associated with significant survival. However, current trends indicate that survival in colorectal cancer will most likely remain below average levels in the near future." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"While cancer is a progressive condition, its underlying causes, like genetic alterations and environmental factors, are not entirely understood. It is therefore important to maintain awareness of cancer. Copyright © 2015 John Wiley & Sons, Ltd." - Anonymous Online Contributor

Unverified Answer

What does ipilimumab usually treat?

"To date, some 50 oncological diseases and conditions have been associated with ipilimumab [4], but to date, a clear pattern has not emerged. These have included primary immunologic conditions such as interstitial lung disease, autoimmune or rheumatic disease [5], autoimmune disorders [e.g., systemic lupus erythematosus and Sjögren’s syndrome] [6], connective tissue disorders [e.g." - Anonymous Online Contributor

Unverified Answer

Is ipilimumab safe for people?

"This is the largest study published in the literature to date in which ipilimumab is studied in a cohort that includes people older than 70 years of age. In a preliminary analysis, no significant changes were observed in rates of AEs between the 2 age cohorts. These data from the phase II study validate the safety and tolerability of ipilimumab when it is given at the highest dose in patients who are 70 years or older." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing cancer?

"Almost one quarter of subjects with no health problems on a general population, cohort developed cancer before the age of 60. Overall cancer incidence was 2 times higher than expected. Subjects already diagnosed with breast cancer have a considerably lower rate of developing further cancer. Thus the lifetime risk of developing cancer is higher for those with an early onset breast cancer than for those with later onset breast cancer. There was no difference on the risk between men and women, or between family members of either gender. The observed difference in cancer rates between men and women cannot be explained by their different lifetime risks." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer?

"A new treatment method called radiation oncology (radiation, chemotherapy, or other therapies) is available for many cancer types, but even so, a full cure is still very likely not practical unless there are major advances in understanding cellular signaling in cancer. Recent advances in genetics have produced a huge new set of new tools, which could lead to a greater understanding of the signal-transduction mechanisms that control cell growth and the mechanisms by which cancer cells escape the regular cell death process known as apoptosis or programmed cell death. In particular, cancer cells have several different pathways through which they can escape this process." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cancer?

"As all cancers cause death earlier than their diagnosis in most parts of the world (this may be due to people being more actively engaged in treatment and survival) the average age of diagnosis is skewed towards earlier ages in the tropics. This is unfortunate, because it means that people with cancer are diagnosed when they are most vulnerable and unable to take advantage of interventions to prevent the development of secondary cancer\n\nAs mentioned above, it is generally true in countries like India that those diagnosed with cancer receive comparatively poorly funded cancer care than those who are healthier. Therefore, in India, less developed areas are less likely to receive the care they need and thus die of illness sooner than industrialized countries." - Anonymous Online Contributor

Unverified Answer

Has ipilimumab proven to be more effective than a placebo?

"Recent findings showed that ipilimumab has shown effectiveness against cancer when compared to placebo. The survival was higher. The median survival was 2.3 months in the study arm compared to 3 months in the placebo arm. The most adverse side effects were rash/eczema and the most common side effects were anxiety, fever, and a mild leukopenia also a severe leukopenia. In addition, the side effects were less common when compared to other immune-based chemotherapy. The most common side effects in this study are not related to ipilimumab so probably would not be seen in other patients with different cancer types." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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