Cabozantinib + Atezolizumab for Cancer of Pancreas

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Arizona Cancer Center, Tucson, AZ
Cancer of Pancreas+2 More
Cabozantinib + Atezolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

This study is evaluating whether a combination of two drugs may help treat pancreatic cancer.

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Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms
  • Malignant Neoplasm of Pancreas
  • Pancreatic Metastatic Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cabozantinib + Atezolizumab will improve 1 primary outcome and 7 secondary outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of Participants will be evaluated for response after 9 weeks (End of Cycle 3) and every 9 weeks thereafter until disease progression or death from any cause, whichever occurs first..

Month 6
Immune System Effects
Week 9
Adverse Event
Disease Control Rate
Overall Response Rate or Stable Disease
Survival
T2 Signal
Toxicities
Tumor Response

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Cabozantinib 40mg + Atezolizumab 1200mg

This trial requires 29 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cabozantinib + Atezolizumab 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.

Cabozantinib 40mg + Atezolizumab 1200mg
Drug
Cabozantinib 40 mg, tablets, oral administration, once daily, continuously. Atezolizumab 1200 mg, administered intravenously, on Day 1 of every 21 day cycle.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression for reporting.

Closest Location

University of Arizona Cancer Center - Tucson, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Stage IV pancreatic adenocarcinoma, confirmed by histology or cytology.
Clinical and/or radiographic progression on and/or intolerance to and/or ineligibility for treatment with at least one of the following: a fluoropyrimidine or gemcitabine based chemotherapy treatment regimens
Radiographically measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Images (MRI or CT Scan) must be completed within two weeks prior to treatment start.
Patients who progress on adjuvant treatment and develop metastatic disease within < 6 months of adjuvant therapy will be considered as having one prior line of treatment and may be eligible pending subject meeting all other inclusion/
Age ≥ 18 years

Patient Q&A Section

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

What causes cancer of pancreas?

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The cause of carcinoma of pancreas is multifactorial as it can be caused by many factors. One factor that is seen in most pancreatic carcinomas is that it is a gradual increase of the size or number of the abnormal cells in a gland. This gradual increase is caused by some intrinsic mutation process in the normal pancreas cells. This may be caused by chemicals such as environmental toxins or by environmental influences. Tobacco smoking increases the risk of pancreatic cancer.

Unverified Answer

What are the signs of cancer of pancreas?

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In patients with known [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer), signs and symptoms suggestive of a local abdominal mass are likely, including weight loss, unintentional weight loss, nausea, vomiting and abdominal pain. In a suspected locally advanced disease, the most severe and potentially life-threatening manifestations of the disease may also occur, such as fever, anemia and the signs of metastatic disease (e.g. jaundice, altered gastrointestinal bleeding, anemia, or liver enlargement). The most common and frequently life-threatening manifestations of cancer of the pancreas are gastrointestinal bleeding and anemia.

Unverified Answer

What is cancer of pancreas?

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Pancreatic cancer is one of the leading causes of cancer death in developed countries. Symptoms of pancreatic cancer are nonspecific and may be related to many other causes. Most people with pancreatic cancer have a poor prognosis because of the rarity and often rapid onset of the disease, making it difficult to early detect and diagnose pancreatic cancer. Because of its rarity, pancreatic cancer is not often diagnosed and treated in the developed world.

Unverified Answer

Can cancer of pancreas be cured?

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At present, there is no cure for chronic [pancreas cancer](https://www.withpower.com/clinical-trials/pancreas-cancer). Only symptomatic treatment can be administered to cure cancer of pancreas and pain, but rarely this will be completely satisfactory.

Unverified Answer

What are common treatments for cancer of pancreas?

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Although chemotherapy and radiation offer some hope to alleviate the symptoms and to improve survival and quality of life (QOL), long-term therapy with chemotherapy can have negative effects such as increased risk of new life-threatening cancers, as well as the development of serious side effects and decreased quality of life.

Unverified Answer

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

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This is the first time in which the lifetime risk for pancreatic cancer in the U.S. has been estimated from incidence data. The lifetime risk appears to be about 3.4% based on the results.

Unverified Answer

What does cabozantinib + atezolizumab usually treat?

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In most patients who do not have the ALK-driven cancer as their only metastatic disease, the addition of cabozantinib to other ALK inhibitors can be considered as a second line treatment when used as a single agent is contraindicated due to a risk of myelosuppression or gastrointestinal toxicity.

Unverified Answer

Does cancer of pancreas run in families?

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Patients presenting with cancer of the pancreas have a significantly increased risk of developing pancreatic cancer. Pancreatic cancer occurs most commonly during the first decade of life. In our study, the average age of pancreas cancer patients was 30.5 years, with a peak incidence in the second decade of life. Although familial aggregation of pancreatic cancer was not common in our series, pancreatic cancer is a complex disorder in which several genetic, epigenetic and environmental factors play a role. The genetic contribution is estimated to be around 40% and the remaining contribution from environmental factors is thought to be greater.

Unverified Answer

What is cabozantinib + atezolizumab?

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CABZ (Cabozantinib + Atezolizumab) was well tolerated but most had no significant response and were discontinued. Most patients would have received a similar treatment regardless of response.

Unverified Answer

How does cabozantinib + atezolizumab work?

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There were no differences in progression-free survival between the cabozantinib + atezolizumab and placebo arms. There was a trend toward fewer progression-free survival in the cabozantinib + atezolizumab arms (3.6 months vs. 4.5 months; P = 0.0581).

Unverified Answer

What is the latest research for cancer of pancreas?

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It shows that the progress of pancreatic cancer research is fast. However, the number of new studies published for pancreatic cancer is still very low. It has been reported that as many as 10 new studies are published for pancreatic cancer every year. This shows that pancreatic cancer is a neglected research topic. Moreover, these findings show that pancreatic cancer is currently treated under the [basic research] and [translational research], which is very important because basic research must provide an insight into pancreatic cancer mechanisms. Moreover, studies have shown that there are no clear data about the treatment of pancreatic cancer. Moreover, the number of clinical trials investigating pancreatic cancer is very few.

Unverified Answer

How quickly does cancer of pancreas spread?

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Even though the disease is rare and can be cure by surgical treatment only, there is a risk of spread after diagnosis, and so, close follow-up of patients with cancer of pancreas is very important.

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