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 range18 Years
SexALL
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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…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: 30 days after the last dose of nivolumab, up to 6 months