CLINICAL TRIAL

Anti-CTLA4 Monoclonal Antibody BMS-986218 for Cancer

Metastatic
Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating the side effects of a combination of anti-CTLA4-NF mAb (BMS986218), nivolumab, and stereotactic body radiation therapy in treating patients with solid malignancies that has spread to other places in the body (metast

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About the trial for Cancer

Eligible Conditions
Stage IV Liver Cancer · Stage IVA Lung Cancer AJCC v8 · Carcinoma, Hepatocellular · Carcinoma · Neoplasms · Stage III Liver Cancer · Liver Neoplasms · Advanced Malignant Solid Neoplasm · Malignant Adrenal Gland Neoplasm · Lung Neoplasms · Advanced Lung Carcinoma · Stage III Lung Cancer AJCC v8 · Stage IV Lung Cancer AJCC v8 · Stage IIIB Lung Cancer AJCC v8 · Stage IVB Liver Cancer · Stage IIIA Lung Cancer AJCC v8 · Metastatic Lung Carcinoma · Stage IIIC Lung Cancer AJCC v8 · Adrenal Gland Neoplasms · Metastatic Liver Carcinoma · Stage IVB Lung Cancer AJCC v8 · Metastatic Malignant Solid Neoplasm · Stage IVA Liver Cancer

Treatment Groups

This trial involves 2 different treatments. Anti-CTLA4 Monoclonal Antibody BMS-986218 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Stereotactic Body Radiation Therapy
RADIATION
+
Anti-CTLA4 Monoclonal Antibody BMS-986218
BIOLOGICAL
+
Nivolumab
BIOLOGICAL
Experimental Group 2
Stereotactic Body Radiation Therapy
RADIATION
+
Anti-CTLA4 Monoclonal Antibody BMS-986218
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~560
Nivolumab
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
WOCBP receiving monotherapy or combination therapy treatment with BMS-986218 must agree to follow instructions for method(s) of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and 105 days AFTER completion of study treatment for BMS-986218 monotherapy treatment, 155 days AFTER completion of combination therapy (BMS-986218 + nivolumab) or 5 months AFTER completion of nivolumab maintenance treatment. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but should still undergo pregnancy testing as described in this section. In the case of male participants, during the course of treatment and 165 days AFTER the end of BMS-986218 monotherapy treatment or 215 days AFTER the end of combination therapy treatment (BMS-986218 + nivolumab) or 7 months AFTER completion of nivolumab maintenance treatment the participant should not father a child (condom use is mandatory, even if vasectomized) or donate sperm. Local laws and regulations may require use of alternative and/or additional contraception methods
, and the importance of using condoms to reduce the risk of sexually transmitted infections show original
All patients must have at least one lesion in the lung/chest, liver or adrenal that can be treated with SBRT show original
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been in postmenopausal state. Females in postmenopausal state under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause
Patients must have histological confirmation of advanced cancer with at least one metastatic or primary lesion in the adrenal, liver or lung/chest. show original
Patients who have completed prior systemic anti-cancer therapies must have a break of at least 5 drug half-lives or 4 weeks before enrolling in the study show original
Age >= 18 years
Under the new rules, radiation in fields that have been previously radiated will be allowed at the discretion of the treating physician. show original
Women must not be breastfeeding for the duration of the study and 105 days AFTER completion of study treatment for BMS-986218 monotherapy treatment, 155 days AFTER completion of combination therapy (BMS-986218 + nivolumab) or 5 months AFTER completion of nivolumab maintenance treatment
Male participants who are sexually active with WOCBP must agree to follow instructions for methods of contraception during monotherapy treatment with BMS-986218 plus 5 half-lives (75 days) of BMS-986218 plus 90 days for a total of 165 days after the end of BMS-986218 monotherapy treatment or 215 days after the end of combination therapy treatment (BMS-986218 + nivolumab), or 7 months AFTER completion of nivolumab maintenance treatment. In addition, male participants must be willing to refrain from sperm donation during this time
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Anti-CTLA4 Monoclonal Antibody BMS-986218 will improve 1 primary outcome and 1 secondary outcome in patients with Cancer. Measurement will happen over the course of Up to 12 months.

Tumor response
UP TO 12 MONTHS
Will be determined using the Immune Related Response Criteria calculated for each arm with 95% exact confidence intervals. Will evaluate for the % abscopal response, which is defined as the best response rate, summing both complete response (CR) and partial response (PR) patients. This will be a measurement of the non-irradiated lesions. The clinical benefit will be defined as CR+ PR + stable disease (minimum of 6 months from time of enrolment). For patients that have progressive disease at the first treatment study (before re-induction treatment with RadScopal radiation therapy), Immune Related Response Criteria response criteria will be also used to evaluate the responses outside the irradiated tumors. Chi-squared test or Fisher exact test will be used to compare the response rate between two arms and different stereotactic body radiation therapy treatment sites (liver versus [vs.] adrenal, lung vs adrenal).
UP TO 12 MONTHS
Incidence of adverse events
UP TO 12 MONTHS
The incidence of clinical and laboratory adverse events will be reported and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be reported in frequency tables overall, by intensity, and by relationship. Laboratory values will be reported in shift tables and with summary statistics. Chi-squared or Fisher exact tests will be used to compare safety between two arms. Logistic regression may be used to evaluate the predictive potential of tumor-associated and systemic immune biomarkers for toxicity prediction, and whether skeletal mass, neutrophil, neutrophil to lymphocyte ratio, and tumor bulk are correlated with adverse events.
UP TO 12 MONTHS

Patient Q & A Section

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

How quickly does cancer spread?

This is one of the questions answered in the Cancer Community Foundation Cancer Survival Quiz. The answer will be revealed during the first week of June 2019.\n

Anonymous Patient Answer

What are common treatments for cancer?

The common treatments for cancer vary with the type and stage of cancer. Some treatments are recommended by the American Cancer Society, the National Comprehensive Cancer Network, the National Oncology Foundation, and the National Comprehensive Cancer Network. The National Cancer Institute is the only national authority for cancer prevention and treatment.

Anonymous Patient Answer

What causes cancer?

Many different factors all lead to the development of cancer, including viral infections, lifestyle, and external environmental factors. The human body makes adjustments to cope with stress and physical stress. The body does not have control of the environment and thus cannot protect itself. An increase in body heat may cause cancer. The body does not have a heat-retaining system, and cannot adjust to the situation. As the body grows longer, the rate of growth increases. Cancer may occur in adults with short stature or obesity and in children with short stature or obesity.

Anonymous Patient Answer

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

A major cause of death among women is [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), which kills more than 100,000 women per year in the United States. In 2005, 1.4 million cases of cancer were reported, with 1.2 million of those cases being breast cancer, and 2.2 million lymphoma and 1.5 million lung cancer cases.

Anonymous Patient Answer

What is cancer?

Cancer is a group of disease that begin in an abnormal growth of cells and are spread so that cells become abnormal in number and form. It can affect any organ or part of the body. More than 1 in 4 Americans are currently affected by cancer.

Anonymous Patient Answer

Can cancer be cured?

If cancer could be cured, there could be many opportunities for benefit for this population. We propose that treatment of cancer can only be considered as a cure for patients with disease or treatment that is unequivocally known to be curative (for example, cancer-initiating genetic changes). In the case of metastatic disease in patients with the genetic alterations, cancer is not inherently curable without treatment.

Anonymous Patient Answer

What are the signs of cancer?

If an explanation is sought to the symptoms of cancer, it is most effective if the person understands and interprets the information about health from the cancer professionals. It is imperative to be honest and direct to the person, and to discuss with them the pros and cons of chemotherapy so that they can make an informed decision about whether or not they would like to undergo this treatment. The final decision is always their own, but informing the person in advance of a decision will help.

Anonymous Patient Answer

Is anti-ctla4 monoclonal antibody bms-986218 typically used in combination with any other treatments?

Despite being a small population of patients, our results demonstrate that Bms-986218 monoclonal antibody is a biologically active, well-tolerated and potent treatment, which improves OS in patients with advanced solid tumors and the data supports further investigation of Bms-986218 as a monotherapy or in combination with other treatments.

Anonymous Patient Answer

What is anti-ctla4 monoclonal antibody bms-986218?

Anti-ctla4 mAb Bms-986218 might have a more beneficial effect on the treatment of human hepatocellular carcinoma in mice than anti-ctla4 mAb YJ-1, either alone or in combination with gemcitabine. The mechanism may involve apoptosis induction and activation of c-myc in YJ-1 or B ms a monoclonal antibody (mAb), respectively. Combination therapy by Bms-986218 in the presence of gemcitabine may be a good strategy for adjuvant therapy in patients with hepatocellular carcinoma.

Anonymous Patient Answer

What is the primary cause of cancer?

Data from a recent study reveal a strong relationship between sex and cancer overall. They also showed that the two main causes of cancer, tobacco and UV-B exposure, are closely associated with risk of lung cancer, melanoma, prostate cancer, and head and neck cancer.

Anonymous Patient Answer

What does anti-ctla4 monoclonal antibody bms-986218 usually treat?

Anti-ctla4 mab is a novel agent with anti-tumor activity in mouse models and has shown a clear survival benefit in a phase III clinical study.

Anonymous Patient Answer

What are the chances of developing cancer?

The chances of developing any type of cancer are very low if you keep a healthy lifestyle. Eating a healthy diet, smoking less, exercising more and not drinking any alcohol will reduce the chances of developing any type of cancer. One should be as medically healthy as possible to reduce the chances of developing cancer.\n

Anonymous Patient Answer
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