Durvalumab for Adenocarcinoma

Phase-Based Estimates
1
Effectiveness
2
Safety
The Moncton Hospital, Moncton, Canada
Adenocarcinoma+1 More
Durvalumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Adenocarcinoma

Study Summary

This study is evaluating whether a new treatment for pancreatic cancer is better than the standard treatment.

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Eligible Conditions

  • Adenocarcinoma
  • Adenocarcinomas of the Pancreas

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 2 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of 35 months.

35 months
Objective Response Rate
Overall Survival
Progression Free Survival

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Gemcitabine plus Nab-Paclitaxel
Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab

This trial requires 180 total participants across 2 different treatment groups

This trial involves 2 different treatments. Durvalumab 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.

Gemcitabine + Nab-Paclitaxel + Durvalumab + TremelimumabGemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days. plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.
Gemcitabine plus Nab-PaclitaxelGemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Tremelimumab
Not yet FDA approved
Paclitaxel
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 35 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 35 months for reporting.

Closest Location

The Moncton Hospital - Moncton, Canada

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 histologically or cytologically confirmed pancreatic ductal adenocarcinoma which is metastatic.
Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Patients must be considered suitable candidates for, and able to receive, first line chemotherapy for metastatic disease with gemcitabine and nab-paclitaxel.
Patient must consent to provision of, and investigator(s) must confirm access to and agree to submit within 4 weeks of randomization to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue of adequate amount and quality in order that the specific correlative marker assays proscribed in the protocol may be conducted.
Patient must consent to provision of samples of blood, serum and plasma in order that the specific correlative marker assays proscribed may be conducted.
Patients must be ≥ 18 years of age.
Patients must have an ECOG performance status of 0 or 1 with a life expectancy of at least 12 weeks.
No prior treatment for metastatic disease is permitted. Patients may have received prior adjuvant chemotherapy if the last dose was given more than 6 months prior to recurrence. Patients may not have received chemoradiotherapy or adjuvant radiation therapy. Patient may not have received nab-paclitaxel as adjuvant therapy. Prior systemic treatment for borderline resectable or locally advanced disease is not permitted. Patients receiving a single dose of radiation (up to 8Gy/800RAD) with palliative intent for pain control are eligible provided a minimum of 14 days have elapsed between the radiation and the date of randomization.
Adequate normal organ and marrow function as defined below (must be done within 14 days prior to registration).
Absolute neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥90 g/L Bilirubin ≤ 1.5 x upper normal limit AST and ALT ≤ 2.5 x upper normal limit Serum creatinine <1.25 UNL or Creatinine clearance ≥40mL/min

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 is adenocarcinoma?

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Adenocarcinoma is one of the most common forms of cancer in the urinary tract. Its symptoms may include bladder pain, dysuria, hesitancy in urinating, lower back pain, and difficulty in retaining urine.\n

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What causes adenocarcinoma?

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The risk of metastasis in adenocarcinoma is higher in patients with higher grade, younger age, and larger tumor size. In addition, patients with adenocarcinoma have a higher risk of developing more distant metastases.

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Can adenocarcinoma be cured?

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On postoperative survival, [cancer stage(s)] was not significantly associated with cancer-specific survival. To date, there have been no reported [cancer cures]. However, in theory, if there were more patients diagnosed with stage IA (T1), the cure rates should be higher than they are because T1 tumors are usually cured by surgery. On the other hand, there is no data to suggest that T3 tumors become [cancer free].[supplied by author] If adenocarcinoma can be cured, there should be a [cancer cure] rate.

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What are the signs of adenocarcinoma?

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A 2014 study concluded that (a) signs of adenocarcinoma may not show up on mammograms until two years after the diagnosis, and (b) signs on a mammogram of adenocarcinoma often look like those seen with non-cancerous processes such as calcification and fatty changes. The study authors call attention to four'signs' on mammograms that may indicate the onset of breast cancer, two of which are also associated with cervical cancer. They also conclude that the presence of these signs should be investigated further and (c) the presence of adenocarcinoma should be taken seriously when interpreting the results of a mammogram.

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What are common treatments for adenocarcinoma?

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Adenocarcinoma commonly spreads to local lymph nodes, distant lymph nodes, or the lungs or liver, and treatment for metastatic adenocarcinoma is primarily based on the tumor's ability to be removed or debulked. Surgery is often combined with adjuvant therapies to try to remove all affected tumor. Tx for metastatic adenocarcinoma is based on the cancer's ability to be treated with chemotherapy, radiation therapy, or hormone therapy. Chemotherapy may be used to help shrink or stabilize an adenocarcinoma. Radiotherapy may also help shrink a tumor. People with metastatic adenocarcinoma can expect to be better, but not cured, from these treatments.

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

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Around 21,871 people in the United States are diagnosed with adenocarcinoma a year. 5.3% of males and 4.1% of females are diagnosed with adenocarcinoma. The annual increase in incidence rates varies between different age groups: 0.1% per year in infants to 4.9% per year in patients aged 90 or more. Most adenocarcinomas are detected in men (59%) than in women (28%); overall, adenocarcinoma occurs in women at a significantly lower rates (12.7%) than men (26.7%).

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How quickly does adenocarcinoma spread?

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Adenocarcinoma spreads more rapidly than [squamous cell carcinoma of the esophagus] (in a pooled analysis) and squamous cell carcinoma of the head and neck (in a retrospective analysis). However, the results may be affected by the way the two cancers are defined and the sample size of both subtypes can affect the rates of spread. If this finding is confirmed prospectively in a larger pooled analysis, then it may lead to more effective cancer screening measures.

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Have there been other clinical trials involving durvalumab?

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Although two trials are completed, both were halted prematurely prematurely owing to study-related adverse experiences. This experience suggests that it would be prudent to reconsider the role of Durvalumab in the treatment of breast cancer patients.

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What does durvalumab usually treat?

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In this cohort of patients with advanced NSCLC, durvalumab treatment was associated with increased progression-free survival and may decrease progression-free survival and overall survival in those with PD-L1 amplification. Durvalumab appears to be associated with a high rate of non-targeted therapy-related hypersensitivity reactions of varying severity but without a clear dose or schedule relationship and without a clear pattern of toxicity.

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What are the latest developments in durvalumab for therapeutic use?

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The phase 3 trial results indicate that the addition of durvalumab to darbepoetin should improve erythropoiesis in myelodysplastic syndrome and chronic myelomonocytic leukaemia. The phase 2 trial results, in combination with postmarketing studies, suggest that the addition of durvalumab could be a key factor in erythroid differentiation in the context of myeloid neoplasms.

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What is the latest research for adenocarcinoma?

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There are new therapies for metastatic adenocarcinoma. Chemotherapy is the newest treatment for patients with metastatic adenocarcinoma. Radiation therapy is one form of treatment for metastatic adenocarcinoma. New therapies include monoclonal antibodies, vaccines, and targeted therapy. A better understanding of mechanisms of tumour cells to spread will lead to more effective treatments.

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What is the average age someone gets adenocarcinoma?

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Adenocarcinoma is more prevalent in men than in women. By the age of 30, the ratio is 3:1. As the rates of survival are greater for women than men, it is likely that they survive longer. This can be attributed to many factors that affect survival rates including screening procedures and treatment options.

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