Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma… (NCT02831933) | Clinical Trial Compass
TerminatedPhase 2
Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma
Stopped: Lack of funding
United States11 participantsStarted 2017-02-15
Plain-language summary
This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous non-small cell lung carcinoma (NSCLC) and metastatic uveal melanoma. In situ gene therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy.
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:
* Male or female ≥18 years of age.
* Histologically or cytologically confirmed stage IV, metastatic squamous or non-squamous NSCLC that has progressed after a platinum-based chemotherapy and after a single-agent immunotherapy OR histologically or cytologically confirmed metastatic uveal melanoma that is immunotherapy naive
* Evaluable or measurable disease as per RECIST 1:1, a target lesion of suitable diameter (at least 5 mm) for SBRT, and a non-target lesion of at least 1 cm in diameter for abscopal effect evaluation.
* ≥ 4 weeks since any major surgery.
* A 2-week washout period post any prior systemic anticancer therapy, RT, and/or investigational therapy is required prior to trial entry. Subject should be adequately recovered from the acute toxicities of any prior therapy.
* Life expectancy greater than or equal to 6 months.
* Eastern Cooperative Oncology Group performance status of 0-1.
* Adequate bone marrow function:
* Absolute neutrophil count ≥ 1.5 x 10\^9/L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
* Platelets ≥ 100 x 10\^9/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
* Hemoglobin ≥ 8 g/dL (without blood transfusion)
* White blood cell count \> 2,500/uL and \< 15,000/uL
* Lymphocyte count ≥ 500/uL
* Adequate liver function (NSLC Cohort):
* Serum bilirubin less than or equal to 1.0 X upper limit of normal (ULN; p…
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
Overall Response Rate (ORR)
Timeframe: 30 days after the last dose of nivolumab, up to 6 months