Immunotherapy and SBRT for Metastatic Head and Neck Carcinomas (NCT03283605) | Clinical Trial Compass
CompletedPhase 1/2
Immunotherapy and SBRT for Metastatic Head and Neck Carcinomas
Canada33 participantsStarted 2018-07-17
Plain-language summary
Immunotherapy targeting the PD-1/PD-L1 pathway had previously been shown to be efficacious in the treatment of patients with metastatic head and neck squamous cell carcinomas. Stereotactic Body Radiotherapy (SBRT) to metastatic lesions causes localized cancer cell killing and the release of cancer cell debris, which could stimulate the immune system in the presence of immunotherapy. The purpose of this study is to assess the tolerability and efficacy of combining Durvalumab (MEDI4736), Tremelimumab and SBRT in controlling cancer progression. SBRT will be administered to patients while they are receiving Durvalumab and Tremelimumab.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pathologically (histologically or cytologically) confirmed diagnosis HNSCC at a metastatic site. This includes histologic variants of SCC such as spindle cell carcinoma, poorly differentiated keratin-positive carcinoma, and lymphoepithelioma. The pathology can come from the most accessible site and does not need to be from the time of diagnosis.
. ≥2 locoregional and/or extracranial metastatic lesions (no brain metastases) that are treatable by SBRT. Lesions that are not measurable per RECIST v1.1 must show progression on 2 consecutive imaging studies with a minimum increase of 1 mm, and must be a mimimum size of 5 mm at time of enrollment. .
. ≤ 4 prior treatment lines with systemic therapy
. ≥2 measurable disease (RECIST) consisting of extracranial metastatic lesions (no brain metastasis) that are treatable by SBRT.
. ≤ 10 metastatic lesions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute toxicities of the treatment
Timeframe: 3 months
2
Progression Free Survival (PFS)
Timeframe: 6 months
Trial details
NCT IDNCT03283605
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
. Evaluation by a radiation oncologist within 45 days prior to study registration
. Evaluation by a medical oncologist within 45 days prior to study registration
Exclusion criteria
. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
. Nasopharyngeal carcinoma
. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
. \>4 prior treatment lines with systemic therapy
. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) ≤ 30 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca/MedImmune and the investigator.
. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg. hormone replacement therapy) is acceptable.
. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug