Trial · NCT02151448
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose (RP2D) (Phase 1) | Up to 24 weeks | Number of patients treated at each of the three possible dose levels of Interferon α (5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2) during the Phase 1 portion of the study. |
| Primary | Adverse Events Possibly, Probably or Definitely Related to Study Treatment | Up to 24 weeks | Number of participants with adverse events (by Grade) that were possibly, probably or definitely related to the combined study immunotherapy regimen (αDC1 vaccines + CKM) per CTCAE v 4.0 (Common Terminology Criteria for Adverse Events). |
| Secondary | Time to Progression (TTP) | Up to18 months | The length of time from the start of treatment until disease progression, per RECIST 1.1 considering only patients whose deaths were from cancer. Disease progression per RECIST 1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Overall Survival (OS) | Up to 5 years | The length of time from the start of treatment that diagnosed patients are still alive. |
| Secondary | Progression-free Survival (PFS) | Up to 5 years | The length of time during and after the treatment that patients remain alive with disease that does not progress. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | CXCL10 (Interferon Gamma-induced Protein 10) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Chemokine CXCL10 (Interferon gamma-induced protein 10) concentration levels measures in peripheral blood as a biomarker of anti-tumor activity. Increased levels can be predictive of good prognosis. |
| Secondary | CXCL11 (C-X-C Motif Chemokine 11) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | CXCL11 (C-X-C motif chemokine 11) protein concentration levels measures in peripheral blood. Increased levels can be predictive of good prognosis. |
| Secondary | Interleukin 10 (IL-10) Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Interleukin 10 (IL-10) (human cytokine synthesis inhibitory factor (CSIF)) concentration levels measures in peripheral blood. Increased levels of IL-10 is associated with advanced disease and poor prognosis. |
| Secondary | Interleukin 6 (IL-6) Cytokine Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Interleukin 6 (IL-6) concentration levels measures in peripheral blood. Increased levels of IL-6 is associated with associated with advanced disease and poor prognosis. |
| Secondary | Interleukin-8 (IL-8) Cytokine Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Interleukin-8 (IL-8) cytokine concentration levels measures in peripheral blood. Increased levels of IL-8 is associated with associated with advanced disease and poor prognosis. |
| Secondary | Stromal Derived Factor 1 Alpha (SDF-1A/CXCL-12) Chemokine Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Levels of stromal derived factor 1 alpha (SDF-1A/CXCL-12) chemokine in peripheral blood. Higher levels of SDF-1A/CXCL-12 is associated with good prognosis. |
| Secondary | Tumor Necrosis Factor (TFNα) Cytokine Levels | Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8) | Tumor necrosis factor (TFNα) cytokine concentration levels measures in peripheral blood. Higher TFNα levels is associated with good prognosis. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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