Trial · NCT03520686
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 24 Months | Defined by RECIST Version 1.1 based on BICR |
| Primary | Change in absolute lymphocyte count (ALC). | Significantly Higher ALC Values Over Time Between Experimental & Control Arms Through 27 Weeks | Change in absolute lymphocyte count (ALC) over time in participants treated with NAI in combination with approved CPI(s) |
| Secondary | Overall Survival (OS) | 24 Months | |
| Secondary | Overall Response Rate (ORR) | 24 Months | Defined by RECIST Version 1.1 based on BICR |
| Secondary | Duration of Response (DOR) | 24 Months | Defined by RECIST Version 1.1 based on BICR. |
| Secondary | PFS | 24 Months | Defined by iRECIST based on BICR. |
| Secondary | Overall Response Rate (ORR) | 24 Months | Defined by iRECIST based on BICR. |
| Secondary | Duration of Response (DOR) | 24 Months | Defined by iRECIST based on BICR. |
| Secondary | Disease Control Rate (DCR) | 2 Months | Confirmed CR, PR, or SD lasting for at least 2 months by RECIST Version 1.1 based on BICR |
| Secondary | Quality of Life based on Patient Reported Outcomes Questionnaires (Cohorts A, B, C only) | 24 Months | FACT-L |
| Secondary | Disease Specific Survival (DSS) | 24 Months | This relates to how DSS will be tracked as part of the analysis at the end |
| Other | Incidence of treatment-emergent AEs and SAEs | 24 Months | Graded using the NCI CTCAE Version 5.0 |
| Other | Immunogenicity profile of NAI in combination with immune CPI(s) ( Cohorts A, B, and C) | 24 Months | Detection of anti-drug antibodies |
| Other | Tumor molecular profiles and correlations with subject outcomes (Cohorts A, B, C only). | 9 Weeks | Genomic sequencing of tumor cells from tissue |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03520686/registered