CLINICAL TRIAL

durvalumab for Cancer

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Waitlist Available · 18+ · All Sexes · Vancouver, Canada

This study is evaluating whether a drug called durvalumab can be used to treat cancer.

See full description

About the trial for Cancer

Eligible Conditions
Solid Malignancies · Neoplasms

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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
durvalumab
DRUG
tremelimumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Tremelimumab
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or the other condition listed above. 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:
Patients must have histologically and/or cytologically confirmed cancer that is advanced / metastatic / recurrent or unresectable and for which no curative therapy exists.
Patients must be considered suitable candidates for and eligible to receive one of the regimens (including durvalumab and tremelimumab alone (dose level 5) included in this protocol and which is open to accrual. For each regimen, specific criteria for registration may be applicable to the cohort/dose level to ensure tolerability in the planned phase II or III trials. Centres must confirm that the planned cohort is open to accrual and whether there are any restrictions on tumour types prior to approaching patients.
For etoposide/carboplatin regimen, patients must have untreated small cell lung cancer (SCLC).
If a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) is available, patients must have provided informed consent for the release of the block. All patients must have provided informed consent for correlative studies.
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). Patients ideally should have measurable disease.
Patients must have an ECOG performance status of 0, 1, or 2 (0 or 1 for untreated SCLC enrolled to etoposide/carboplatin). Patients with PS 2 must be considered fit for first line cytotoxic or immune based therapy and discussed with CCTG prior to enrolment.
Previous Therapy
• Patients should not have received prior chemotherapy for advanced disease. Exceptions may be made for selected patients and regimens. Patients planned for dose level 5 may have received one line or prior chemotherapy. Consult CCTG before approaching patients.
Notes: Patients planned for cisplatin regimens should have received no more than 250mg mg/m2 prior to cisplatin.
• For dose levels 0-3, patients with untreated SCLC must have received two cycles of their first etoposide carboplatin regimen prior to registration to that chemotherapy cohort. For dose level 4, SCLC patients planned for the etoposide/carboplatin cohort may not have had prior chemotherapy regimens and do not have to have their first two cycles of etoposide-platinum prior to study entry.
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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: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 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 durvalumab will improve 1 primary outcome and 3 secondary outcomes in patients with Cancer. Measurement will happen over the course of 24 months.

Efficacy of durvalumab ± tremelimumab in patients receiving standard chemotherapy. Assessed by chest/abdomen/pelvis CT scan and other scans as necessary to document
24 MONTHS
disease
24 MONTHS
Number of Participants with treatment-related adverse events as assessed by CTCAE v 4.0
24 MONTHS
24 MONTHS
Characterize the immunogenicity of durvalumab ± tremelimumab in patients receiving standard chemotherapy
24 MONTHS
24 MONTHS
Confirm the recommended phase II dose (RP2D) of durvalumab ± tremelimumab in patients receiving standard chemotherapy
24 MONTHS
24 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.

What is cancer?

In general, cancer is a disease that arises from uncontrolled cell growth. However, there are multiple cancer types. For cancer to form, a single normal cell must undergo a genetic transformation. The cells that undergo this process must be able to leave the body via a blood vessel or lymph vessel. Cancer starts at various sites in the body, but the first cancer is brain cancer.\n\nIn health, blood flows through the heart to the body and the brain, then to other organs and then back to the heart. However, in cancer, in a tumor, or other growth from a single cell, the heart is not functioning normally and the blood cannot flow to other body tissue.

Anonymous Patient Answer

What causes cancer?

The causes of cancer differ between genders, but cancers are likely influenced by many different factors in both the environment and the biology of the cells that carry tumors. Cancer is a disease of abnormal growth.

Anonymous Patient Answer

What are the signs of cancer?

These include, in order of prevalence, unintentional weight loss, loss of appetite, constipation or diarrhea, unintentional hand eczema (also known as palmar erythema), unexplained muscle weakness, sudden weight gain, swollen ankles, and unexplained itching. However, not all of these are conclusive signs or symptoms of cancer. Many signs can reflect a common ailment or symptom and must be considered when planning treatment for the cause.

Anonymous Patient Answer

Can cancer be cured?

While there are some patients who can experience a complete remission with surgery, chemotherapy, and other modalities, many individuals will not respond to all the current treatments. Although a cure is not guaranteed for all cancer patients, early detection and treatment may still result in a significant improvement in the quality of life of cancer patients, especially if it can be done in an early and non-emergency setting.

Anonymous Patient Answer

What are common treatments for cancer?

Results from a recent paper shows that patients with cancer are most concerned with treatments for their disease, with a focus on improving quality of life and alleviating symptoms. There were concerns about treatment toxicity and whether chemotherapy and certain types of radiation oncology were compatible with other treatment options such as cancer surgery.

Anonymous Patient Answer

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

Each year, around 1.6 million Americans are diagnosed with cancer and approximately 1.9 million are diagnosed with a fatal disease of the breast while at least half of all deaths in the United States result from cancer.

Anonymous Patient Answer

How serious can cancer be?

The data in this report provide strong evidence for the importance of examining cancer patients for signs of malnutrition, anemia and dehydration when they are hospitalized as well as following them closely when they are out to ensure treatment is given correctly so that any of the complications can be prevented, minimized and/or corrected.

Anonymous Patient Answer

Who should consider clinical trials for cancer?

On the basis of results presented here, we conclude that a well defined target population for cancer trials, such as those of younger people, those with high stage/grade disease, and those with disease that has progressed in the metastatic phase should be eligible. It is necessary to define in practice the eligibility criteria for clinical trials. Physicians' willingness to contribute their time to clinical research can increase through the dissemination of clinical trial protocols.

Anonymous Patient Answer

What is durvalumab?

Durvalumab is a FDA-approved monoclonal antibody for the treatment of advanced squamous cell carcinoma of the head and neck (SCCNHN), which is currently undergoing Phase II clinical trials. The overall objective of early clinical trials is to assess dosing and timing patterns that maximize antitumor responses and minimize off-target morbidities. The safety and efficacy of durvalumab have not yet been established in SCCNHN, and therefore, further studies are warranted to verify whether duravelumab can improve progression-free survival relative to platinum-based chemotherapy.

Anonymous Patient Answer

Is durvalumab typically used in combination with any other treatments?

The current study highlighted the potential benefits in combination therapy with PD-1 targeting agents. This could be useful in improving the outcome of cancer patients who are either progressing or refractory to other therapies.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer?

The discovery of the new chemotherapeutic agents and radiotherapeutic agents for NSCLC and [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is an ongoing process in which we as clinicians have a critical role. The advances in treatments for cancer has come faster than we realize. There are many new agents in clinical trial for new treatments (e.g. immunotherapy, biological response modifiers, etc.). There are no drugs like Gleevec (c-kit inhibition) or Sutent (multitarget kinase inhibition), but I believe new therapeutic strategies in the future will yield those agents for those patients who are benefiting from the agents currently in use.

Anonymous Patient Answer

Is durvalumab safe for people?

Median (95 % CI) primary outcome outcomes and disease progression rates are similar in the two cohorts. Durvalumab treatment appears to be well tolerated in this series of patients with advanced solid tumors with moderate-to-severe disease symptoms. More patients died and underwent transplantation; more patients were hospitalized; and more patients experienced adverse events in the durvalumab cohort compared to patients in the placebo cohort.

Anonymous Patient Answer
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