Trial · NCT04875195
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator | Up to approximately 30 months | ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose- positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by investigator is presented. |
| Secondary | ORR Per Lugano Classification as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 30 months | ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by BICR is presented. |
| Secondary | Duration of Response (DOR) Per Lugano Classification as Assessed by Investigator | Up to approximately 51 months | For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants were evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). DOR as assessed by investigator is presented among participants who demonstrated CR or PR. |
| Secondary | DOR Per Lugano Classification as Assessed by BICR | Up to approximately 51 months | For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants were evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). DOR as assessed by BICR is presented among participants who demonstrated CR or PR. |
| Secondary | Area Under the Curve (AUC) Early Cycle of Pembrolizumab | Predose on Day 1 and Day 42 of Cycle 1 (cycle length=6 weeks) | AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time. Blood samples were collected to determine the AUC of pembrolizumab during Cycle 1 (early cycle). A cycle was 6 weeks. |
| Secondary | Area Under the Curve (AUC) Steady State of Pembrolizumab | Predose on Day 1 and Day 42 of Cycle 4 (cycle length=6 weeks) | AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time. Blood samples were collected to determine the AUC of pembrolizumab during Cycle 4 (steady state). A cycle was 6 weeks. |
| Secondary | Maximum Serum Concentration (Cmax) Early Cycle of Pembrolizumab | Predose on Day 1 of Cycle 1 and end of infusion on Day 1 of Cycle 1 (cycle length = 6 weeks) | Cmax is defined as the maximum serum drug concentration. Blood samples were collected to determine the Cmax of pembrolizumab during Cycle 1 (early cycle). |
| Secondary | Maximum Serum Concentration (Cmax) Steady State of Pembrolizumab | Predose on Day 1 of Cycle 4, and end of infusion on Day 1 of Cycle 4 (cycle length = 6 weeks) | Cmax is defined as the maximum serum drug concentration. Blood samples were collected to determine the Cmax of pembrolizumab during Cycle 4 (steady state). |
| Secondary | Trough Serum Concentration (Ctrough) Early Cycle of Pembrolizumab | Predose on Day 1 of Cycle 1 and Day 42 of Cycle 1 (cycle length = 6 weeks) | Ctrough is defined as the lowest serum drug concentration at the end of dosing interval. Blood samples were collected to determine the Ctrough of pembrolizumab during Cycle 1 (early cycle). |
| Secondary | Trough Serum Concentration (Ctrough) Steady State of Pembrolizumab | Predose on Day 1 of Cycle 1 and Day 42 of Cycle 4 (cycle length = 6 weeks) | Ctrough is defined as the lowest serum drug concentration at the end of dosing interval. Blood samples were collected to determine the Ctrough of pembrolizumab during Cycle 4 (steady state). |
| Secondary | Antidrug Antibody Levels (ADA) for Pembrolizumab | Predose 0-4 hours on Cycle1 Day1, Cycle2 Day1, Cycle4 Day1, Cycle5 Day1, Cycle7 Day1, Cycle9 Day1, Cycle13 Day1, Cycle17 Day1 and end of infusion on Cycle1 Day1, Cycle4 Day1 and anytime on Cycle1 Day22 and Cycle4 Day22 (cycle length = 6 weeks) | Blood samples were collected and assayed for anti-pembrolizumab antibodies presence using a validated electrochemiluminescence immunoassay. Negative ADA refers to all pre-treatment and postdose samples negative in the assay for antibodies against pembrolizumab and the concentration of pembrolizumab in the last postdose sample below the drug tolerance level. Treatment emergent positive was defined as pre-treatment sample negative and at least one postdose sample positive in the assay or pre-treatment and postdose sample positive with an increase in titer (≥2 fold of baseline). Non-treatment emergent positive was defined as pre-treatment sample positive and postdose sample negative or pre-treatment and postdose sample positive with a postdose titer \<2 fold of baseline. Neutralizing positive was defined as at least 1 of the ADA positive samples test positive in the neutralizing assay. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 51 months | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to AE | Up to approximately 25 months | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
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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