A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer (NCT03212469) | Clinical Trial Compass
CompletedPhase 1/2
A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer
France54 participantsStarted 2017-06-20
Plain-language summary
The study is an open label, multicentric, Phase I/II trial aiming to evaluate the safety, the clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.
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:
I1. Male or Female patients ≥18 years of age or older.
I2. Histologically or cytologically proven metastatic squamous cell carcinoma (from head and neck, oesophagus, lung, cervix, vagina, vulva or anus) with the following features:
* Previously treated with at least one prior regimen (chemotherapy, signal transduction inhibitors or radiotherapy)
* To be treated with radiotherapy at primary tumor site or metastatic site or menacing metastatic site.
* The sites of metastases allowed are: soft tissue, peripheral lung, and liver.
* Patients with brain and bone metastasis to be treated with radiotherapy are not allowed. Patients with asymptomatic brain metastasis can be included.
* The total tumor volume to be irradiated must not exceed 400 cc.
I3. At least one tumor lesion must be accessible to radiation therapy and at least another tumor site can be spared from radiation therapy (unirradiated site).
I4. At least one unirradiated and one irradiated tumor site must be accessible to tumor biopsy.
I5. Known availability of an archived block
I6. The irradiated and unirradiated tumor sites must be measurable as per RECIST 1.1
I7. Patients must have no history of previous radiation therapy within the body area to be irradiated.
I8. Minimal wash-out periods from previous treatments to C1D1 must be
* Any investigational agent \> 4 weeks
* Bevacizumab \> 6 weeks
* Chemotherapy \> 4 weeks
* TKI \> 4 weeks
* RANK ligand agonists \> 6 weeks
* Immunosuppressive m…
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.