Trial · NCT03104699
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab | 21 days | A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period). |
| Primary | Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 3 years | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious), regardless of causality, is located in the 'Reported Adverse Events' Section. |
| Primary | Phase 2: Objective Response Rate (ORR) as Determined by an Independent Endpoint Review Committee (IERC) | Up to 3 years | ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| 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) | The percentage of PD-1 receptor occupancy on circulating T cells was measured as an indication of target engagement. An increase in percent occupancy indicates a potential increase in drug effectiveness. |
| 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) | Blood samples were collected for serum balstilimab concentration determinations. Results are reported as micrograms/milliliter (ug/mL). |
| 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) | Blood samples were collected for serum balstilimab concentration determinations. Results are reported as hours\*micrograms/milliliter (h\*µg/mL). |
| Secondary | Phase 1: Number of Participants With Serum Anti-drug Antibodies (ADAs) for Balstilimab | Up to 2.5 years | Blood samples were collected for serum balstilimab ADA determination. |
| Secondary | Phase 2: Number of Participants Experiencing TEAEs | Up to 3 years | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
| 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) | Blood samples were collected for serum balstilimab concentration determinations. Results are reported in μg/mL. |
| 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) | Blood samples were collected for serum balstilimab concentration determinations. Results are reported in day\*μg/mL. |
| Secondary | Phase 2: Number of Participants With Serum ADAs for Balstilimab | Up to 2.5 years | Blood samples were collected for serum balstilimab ADA determination. |
| Secondary | Phase 2: ORR as Determined by the Investigator | Up to 3 years | ORR was defined as percentage of participants with a BOR of CR or PR, as determined by the investigator per RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 2: Duration of Response (DOR) | Up to 3 years | DOR was defined as time from first observation of response to first observation of documented progressive disease (PD) (or death within 12 weeks after last tumor assessment), per RECIST 1.1 and as determined by an IERC and the investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment. |
| Secondary | Phase 2: Disease Control Rate (DCR) as Determined by an IERC | Up to 3 years | DCR was defined as the percentage of participants with CR, PR, or stable disease (SD) for at least 12 weeks. CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). |
| Secondary | Phase 2: Tumor Control Rate (TCR) as Determined by an IERC | Up to 3 years | TCR was defined as percentage of participants who had a BOR of either SD or a confirmed objective response (CR or PR). CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). |
| Secondary | Phase 2: Time to Response (TTR) as Determined by an IERC | Up to 3 years | TTR was defined as the time from the first dose date to first observation of confirmed response. |
| Secondary | Phase 2: Progression-free Survival (PFS) | Up to 3 years | PFS was defined as time from first treatment administration to first observation of documented PD (or death within 12 weeks after last tumor assessment), per RECIST 1.1, as determined by an IERC and investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment. |
| Secondary | Phase 2: Overall Survival (OS) | Up to 3 years | OS was defined as time from start of treatment to death. For participants who were still alive at the time of data cutoff for trial analysis or who were lost to follow-up, survival was censored at the last recorded date that the participant was known to have been alive as of the cutoff date for analysis. |
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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