Trial · NCT03049618
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 22 months | Calculated based on the evaluable population of patients who received at least 1 dose of therapy. Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Duration of Response | Up to 22 months | Duration of response is measured from date of first confirmed response until date of disease progression. |
| Secondary | Number of Participants With Adverse Events | Adverse events were collected from first dose of study treatment up to 30 days after last dose of treatment, up to 21 months (number of treatment given ranged from 1 cycle to 30 cycles). | The adverse events were graded as per common terminology criteria for adverse events(CTCAE) version 4.0. For a detailed list of adverse events refer to the adverse event module. |
| Secondary | Overall Survival (OS) | Up to 41 months | OS is the duration from study entry to death. Participants last known to be alive are censored at date of last contact. |
| Secondary | Progression Free Survival (PFS) | Up to 23 months | PFS was defined as duration of time from the first dose of study drug to the first documentation of Progressive Disease (PD) by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: \>=20% increase (\>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed, and disease is progressing, regardless of the status of the target lesions. |
| Other | Association of Biomarker With Overall Response Rate - HPV Status | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarker With Overall Response Rate - P16 Status | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarkers With Overall Response Rate - EphrinB2 Status | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarkers With Overall Response Rate - PD-L1 Status | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarkers With Overall Response Rate - EphrinB2 Positive/HPV-negative | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarkers With Overall Survival (OS) - HPV Status | Up to 34 months | OS was calculated from study entry to date of death. Participants last known to be alive are censored at date of last contact. |
| Other | Association of Biomarkers With Overall Survival (OS) - P16 Status | Up to 34 months | OS was calculated from study entry to date of death. Participants last known to be alive are censored at date of last contact. |
| Other | Association of Biomarkers With Overall Survival (OS) - EphrinB2 | Up to 24 months | OS was calculated from study entry to date of death. Participants last known to be alive are censored at date of last contact. |
| Other | Association of Biomarkers With Overall Survival (OS) - PD-L1 Status | Up to 34 months | OS was calculated from study entry to date of death. Participants last known to be alive are censored at date of last contact. |
| Other | Association of Biomarkers With Overall Survival (OS) - EphrinB2 Positive/HPV-negative | Up to 34 months | OS was calculated from study entry to date of death. Participants last known to be alive are censored at date of last contact. |
| Other | Association of Biomarkers With Progression Free Survival (PFS) - HPV Status | Up to 11 months | From study entry to the date of first documented disease progression or death due to any cause, whichever came first. |
| Other | Association of Biomarkers With Progression Free Survival (PFS) - P16 Status | Up to 11 months | From study entry to the date of first documented disease progression or death due to any cause, whichever came first. |
| Other | Association of Biomarkers With Progression Free Survival (PFS) - EphrinB2 Status | Up to 11 months | From study entry to the date of first documented disease progression or death due to any cause, whichever came first. |
| Other | Association of Biomarkers With Progression Free Survival (PFS) - PD-L1 Status | Up to 11 months | From study entry to the date of first documented disease progression or death due to any cause, whichever came first. |
| Other | Association of Biomarkers With Progression Free Survival (PFS) - EphrinB2 Positive/HPV-negative | Up to 11 months | From study entry to the date of first documented disease progression or death due to any cause, whichever came first. |
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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GET https://conductscience.org/api/trials/v1/NCT03049618/registered