Nivolumab 240 MG for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Roswell Park Cancer Center, Buffalo, NY
Adenocarcinoma+1 More
Nivolumab 240 MG - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a drug called nivolumab may help treat pancreatic cancer.

See full description

Eligible Conditions

  • Adenocarcinoma
  • Gastro-oesophageal Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Adenocarcinoma

Study Objectives

This trial is evaluating whether Nivolumab 240 MG will improve 1 primary outcome and 3 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of 12 months.

12 months
Number of patients with 12-month progression free survival
Number of subjects who receive short course chemotherapy with immunotherapy that achieve 12-month progression free survival
2 year
Occurrence of Significant Toxicity, as measured by Number of Grade 3 and Grade 4 Adverse Events (Combined) Attributable to Immunotherapy
Overall Survival, as measured by the rate of survival in patients

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Adenocarcinoma

Trial Design

1 Treatment Group

Cohort 2
1 of 1
Experimental Treatment

This trial requires 74 total participants across 1 different treatment group

This trial involves a single treatment. Nivolumab 240 MG is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohort 2
Drug
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2. Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 year for reporting.

Closest Location

Roswell Park Cancer Center - Buffalo, NY

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:
Subjects with a diagnosis of advanced unresectable or metastatic gastroesophageal adenocarcinoma (eg. gastric, gastroesophageal junction, and esophageal adenocarcinoma)
Be willing and able to provide written informed consent/assent for the trial
Age > 18 years
ECOG performance status ≤ 1
Absolute neutrophil count ≥ 1,500/mL
Platelets ≥ 100,000/mL
Total bilirubin ≤ 1.5x upper limits of normal, unless the patient has known Gilbert's disease.
AST/ALT ≤ 2.5 upper limits of normal, or < 5x ULN for subjects with liver metastases
Creatinine ≤ 1.5 mg/dl. If Creatinine > 1.5 mg/dl, creatinine clearance > 60 ml/min
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 28 days prior to initiation of treatment on Day 1.

Patient Q&A Section

What are common treatments for adenocarcinoma?

"We were unable to identify any treatments that have a low risk/no burden and therefore may be considered. These would be effective and would have the benefit of being low-risk treatments of adenocarcinoma. We identified no new drugs that appear to have a low risk/no burden (ie, with less risk than cisplatin-based chemotherapy)." - Anonymous Online Contributor

Unverified Answer

What is adenocarcinoma?

"Adenocarcinoma is a type of cancer that forms in the stomach and esophagus. More than 90% of the people with adenocarcinoma of the esophagus, stomach, and colon, have this type of cancer. Adenocarcinoma appears in the stomach and esophagus more often in men than in women. It is an aggressive form of cancer that has few or no symptoms in early stages. Once it has spread, it can create symptoms by blocking the digestive tract, causing vomiting and pain." - Anonymous Online Contributor

Unverified Answer

Can adenocarcinoma be cured?

"Adenocarcinoma has a poor long-term prognosis and in no cases has cure been reported. However, long-term survival has risen with increasing survival. Adequate treatment can offer long-term survival and can result in cure if the cancer is adequately controlled." - Anonymous Online Contributor

Unverified Answer

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

"The yearly age-adjusted incidence of adenocarcinoma in the United States is 14.3 per 100,000 per year. This is slightly higher than the annual incidence reported by the Cancer Surveillance and End Results Program of the National Comprehensive Cancer Network (31 per 100,000 per year). Women have 2-fold higher incidence compared to men and the incidence of adenocarcinoma increases with age." - Anonymous Online Contributor

Unverified Answer

What are the signs of adenocarcinoma?

"Most men with prostate cancer have symptoms. Symptoms suggestive of prostate cancer include painful ejaculation, erectile dysfunction, increased urge to urinate, or unexplained weight loss. However, many men with prostatitis have a symptom similar to those of prostate cancer." - Anonymous Online Contributor

Unverified Answer

What causes adenocarcinoma?

"Both diet and lifestyle factors can affect how the gastrointestinal tract and pancreas work, leading to cancers of these organs. Adenocarcinoma, which makes up about five percent of human cancers, is a specific type of cancer of the digestive tract. These cancers are often associated with prolonged use of alcohol or smoking. Adenocarcinoma is most common in the colon, but can appear in all parts of the GI tract. Adenocarcinoma is a type of pancreatic cancer which accounts for the majority of pancreatic cancer related death. Adenocarcinoma of the pancreas is an unusual group of cancers with a wide array of risk factors." - Anonymous Online Contributor

Unverified Answer

Is nivolumab 240 mg safe for people?

"Nivolumab 240 mg produced a comparable safety profile to a more commonly studied dose of 140 mg. This dose could be considered safely for treatment of metastatic or advanced cancers in people with no indication for previous chemotherapy." - Anonymous Online Contributor

Unverified Answer

Has nivolumab 240 mg proven to be more effective than a placebo?

"Results from a recent paper indicate that NIV, at 240 mg once weekly, improves progression-free survival significantly in patients with RR-mantle RCC undergoing first-line AUCI with or without bortezomib. NIV administered every 2 weeks may be considered superior to other dosing schedules in this setting." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing adenocarcinoma?

"In women younger than age 55, adenocarcinoma is the second most common malignancy in the breast. In postmenopausal women aged 70-80, invasive lobular carcinoma is more common. The incidence of adenocarcinoma increases with age, rising exponentially with age of 80." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating adenocarcinoma?

"Most cancer patients will receive radiation therapy for cancer treatment, but it is still a large dilemma to the doctor where other less invasive therapies should be applied for patients to decrease the negative consequences of the radiation therapies. Now, with advances in molecular biology and biotechnology, the study of adenocarcinoma is a hot topic for the academic world, medical industry, and the public who is trying to stop or find a way to treat this deadly cancer. Most of the researches focus on the metastasis and cancer heterogeneity among cancer cells. The heterogeneity is mainly responsible for the different survival times of each tumor cells. However, until now, researches for adenocarcinoma are limited in the scope in which it is to treat." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for adenocarcinoma?

"Clinical trials, but not meta-analyses, are more likely to find evidence that adenocarcinoma behaves differently in men than in women. Although women with nonmetastatic adenocarcinoma have improved outcome, those women who have not been treated have similar outcome to those undergoing treatment, suggesting the necessity of further investigation." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nivolumab 240 mg for therapeutic use?

"Nivolumab 240 mg for the treatment of the metastatic PD-L1 positive solid tumour will be introduced in 2018 on the NHS in the United Kingdom under the NICE's new pathway for cancer therapies. The cost for the treatment of a patient will be around £26,000." - 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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