Trial · NCT03104699
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab | 21 days | DLT Analysis Set: all participants who were enrolled for DLT evaluation (excluding participants enrolled to backfill cohorts) and either received all balstilimab administrations or stopped treatment due to a DLT during the DLT evaluation period. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 3 years | Safety Analysis Set: all participants who received at least 1 dose of balstilimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) as Determined by an Independent Endpoint Review Committee (IERC) | Up to 3 years | Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Receptor Occupancy of Circulating T Cells | 4 hours after the first dose (Cycle 1 Day 1) and immediately prior to the second dose (Cycle 2 Day 1) (2-3 weeks/cycle) | Receptor Occupancy Analysis Set: all participants who completed ≥1 balstilimab infusion, with adequate measurements of PD-1 receptor occupancy on circulating T cells. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points. | percent occupancy | MEAN |
| SECONDARY | Phase 1: Maximum Observed Concentration (Cmax) of Balstilimab | Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks) | Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion of study drug and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase 1: Area Under the Drug Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Balstilimab | Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks) | Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points. | h*µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase 1: Number of Participants With Serum Anti-drug Antibodies (ADAs) for Balstilimab | Up to 2.5 years | Safety Analysis Set: all participants who received at least 1 dose of balstilimab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Number of Participants Experiencing TEAEs | Up to 3 years | Safety Analysis Set: all participants who received at least 1 dose of balstilimab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Cmax of Balstilimab | Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks) | Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase 2: AUC0-last of Balstilimab | Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks) | Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points. | day*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase 2: Number of Participants With Serum ADAs for Balstilimab | Up to 2.5 years | Safety Analysis Set: all participants who received at least 1 dose of balstilimab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: ORR as Determined by the Investigator | Up to 3 years | Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Duration of Response (DOR) | Up to 3 years | Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Phase 2: Disease Control Rate (DCR) as Determined by an IERC | Up to 3 years | Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Tumor Control Rate (TCR) as Determined by an IERC | Up to 3 years | Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Time to Response (TTR) as Determined by an IERC | Up to 3 years | Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Phase 2: Progression-free Survival (PFS) | Up to 3 years | Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Phase 2: Overall Survival (OS) | Up to 3 years | Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure. | months | MEDIAN |
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
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GET https://conductscience.org/api/trials/v1/NCT03104699/outcomes