Durvalumab for Advanced Rare Tumours

Phase-Based Estimates
1
Effectiveness
2
Safety
London Regional Cancer Program, London, Canada
Durvalumab - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Advanced Rare Tumours

Study Summary

This study is evaluating whether chemotherapy or other treatments can help people with cancer.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 4 secondary outcomes in patients with Advanced Rare Tumours. Measurement will happen over the course of 48 months.

48 months
Number and severity of adverse events
Objective response rate measured by RECIST version 1.1
Progression free survival based on Kaplan-Meier method
Response duration , based on Kaplan-Meier method
Time to progression based on Kaplan-Meier method

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Durvalumab + Tremelimumab

This trial requires 140 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.

Durvalumab + TremelimumabDurvalumab 1500 mg IV 60 min Day 1 every 4 weeks Tremelimumab 75 mg IV 60 min Day 1, cycles 1-4
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Tremelimumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 48 months for reporting.

Closest Location

London Regional Cancer Program - London, Canada

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Advanced Rare Tumours. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Salivary carcinoma (excluding adenoid cystic carcinoma histology)
Carcinoma of unknown primary with tumour infiltrating lymphocytes (TILs) and/or expressing PD-L1
Mucosal melanoma
Acral melanoma
Osteosarcoma
Undifferentiated pleomorphic sarcoma
Clear cell carcinoma of the ovary
Squamous cell carcinoma of the anal canal (SCCA)
All patients must have a tumour tissue from their primary or metastatic tumour available
Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).

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 are the signs of advanced rare tumours?

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There were no features common to all rare tumours. Advanced slow-growing tumours were more likely to occur in the head and neck region, and metastasis to bone is more likely in patients with cancers arising in the head and neck region compared with primary tumours.

Unverified Answer

How many people get advanced rare tumours a year in the United States?

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The incidence of these rare tumours in the US is relatively stable, with a mean of 2.45 new diagnoses per 100,000 population per year between 2004 and 2015. Over this time period, the most common rare tumours were Merkel cell carcinoma and malignant peripheral nerve sheath tumour. Over the same period, the incidence of cholangiocarcinoma, peritoneal cancer, and multiple endocrine neoplasia type1 was stable.

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Can advanced rare tumours be cured?

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Patients with ATN have very good 10 year survival, and some might be curable. There is no prognostic factor that would permit to predict whether a patient might be curable.

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What is advanced rare tumours?

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Advances in the study of rare cancers are encouraging, but the next challenge will likely include clinical research in the development of novel and effective therapies.

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What are common treatments for advanced rare tumours?

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There tends to be poor adherence to clinical trials of new agents and the number is small in comparison with drugs for common cancers. This may have some impact on the quality of evidence available for advanced rare tumours. There appears also to be a discrepancy between reported prescribing patterns and the extent to which patients are benefiting from their treatment. Future studies will require more explicit standardisation of patient selection, inclusion criteria and study design to optimize outcomes in a more explicit and robust manner.

Unverified Answer

What causes advanced rare tumours?

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The causes of AROT remain poorly understood and the vast majority will be treated as rare tumour syndromes. As a group of patients with rare tumours, the prognosis is poor, but some patients (especially those with rare tumours presenting early) have a better outcome than patients with rare tumours presenting later. A multidisciplinary approach is required to provide an effective treatment.

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Does advanced rare tumours run in families?

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As of this time, no such reports involving such disease have been reported. Based upon these observations and current knowledge of the cause, it would be most prudent to recommend that, while the parents and family are examined, genetic testing should be considered. Genetic testing should be offered at the latest to all individuals with advanced rare tumours in a family. However, this can be challenging due to the number of possible mutations, and to reach a diagnosis, it should be done with a specialized team of clinicians.

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Who should consider clinical trials for advanced rare tumours?

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Clinical trials should be offered to patients who will benefit from clinical treatment and are willing to participate, with particular emphasis on patients who are young or elderly, oncological patients with poor performance status, or in the context of palliative care.

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How serious can advanced rare tumours be?

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Advanced rare tumours can involve multiple sites; metastases from the lung, brain or bone. In addition, advanced rare tumours can have debilitating effects on individual patients, which should be kept in mind when making management decisions. Advanced rare tumours have been almost uniformly poor prognostic indicators, except for brain metastases.

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Has durvalumab proven to be more effective than a placebo?

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This phase 3 study shows that patients receiving 200 mg/m³ of durvalumab had a significantly longer progression-free survival compared to patients receiving placebo in addition to standard of care chemotherapy for patients with mCLL. Additional randomized controlled trials of durvalumab in combination with anticancer chemotherapies for patients with the previously described subtypes of mCLL are warranted to determine if this treatment strategy should be incorporated into practice to improve outcomes.

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Does durvalumab improve quality of life for those with advanced rare tumours?

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While the short-term QoL improvement observed with durvalumab therapy suggests that a longer follow-up period may prove that sustained benefit may be observed, the QoL questionnaire was poorly suited to evaluate QoL improvement. It appears that no QoL benefit was sustained during long-term therapy with durvalumab. Identifying the relevant patient domains and QoL improvement will be key during future studies.

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What are the common side effects of durvalumab?

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Durvalumab is well tolerated in patients with advanced solid tumours. In general, side effects occur in less than 5% of patients, and are manageable. Most of these are mild or moderate in severity.

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