Can vaccines help prevent cancer?

Primary Outcome Measures :

  1. To assess the safety and tolerability of EMD 521873 given in combination with local irradiation of pulmonary primary tumor/metastases and to determine whether the maximum tolerated dose (MTD) is reached with EMD 521873 doses of up to 0.45 mg/kg. [ Time Frame: Incidence of DLTs occurring during the first cycle (21 days) of administration of any dose of EMD 521873 following radiotherapy ]

Secondary Outcome Measures :

  1. Evaluate the pharmacokinetics (PK) of EMD 521873 in combination with local tumor irradiation [ Time Frame: First 4 cycles of treatment ]

  2. Evaluate the immunogenicity of EMD 521873 in combination with local tumor irradiation by measuring the induction of anti-EMD 521873 antibodies [ Time Frame: First 4 cycles of treatment in each cycle, then every 4 cycles ]

  3. Collect evidence of best overall response, changes in tumor marker levels and circulating tumor cell numbers after treatment with EMD 521873 in combination with local tumor irradiation [ Time Frame: First 4 cycles of treatment ]

  4. Collect evidence of best overall response after second-line therapy and duration of the response when it is shown [ Time Frame: At one year of follow up ]

  5. Evaluate progression-free survival and overall survival [ Time Frame: At one year of follow up ]

  6. Evaluate biological/immune responses following treatment with EMD 521873 by assessing changes in relevant parameters including leukocyte subset analysis [ Time Frame: First 4 cycles of treatment ]

  7. Evaluate biological/immune responses following treatment with EMD 521873 by assessing changes in relevant parameters including: molecular markers of immune activation (e.g. cytokines/chemokines, IL-2 receptor and neopterin) [ Time Frame: First 4 cycles of treatment ]

https://clin.larvol.com/trial-detail/NCT02113683