Trial · NCT04524689
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks) | DLT-evaluable population included participants who received 1 cycle with at least 80% of the intended dose for each study treatment of the combination during the safety run-in at both doses of tusamitamab ravtansine in Part A (doublet cohort), Part B (triplet cohort) or Part C (quadruplet cohort). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Doublet Cohort: Objective Response Rate (ORR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort) at both tusamitamab ravtansine doses. | percentage of participants | NUMBER |
| PRIMARY | Quadruplet Cohort: Objective Response Rate | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 139.9 weeks | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet) | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Doublet and Quadruplet Cohorts: Progression-free Survival (PFS) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet) and 139.9 weeks (quadruplet) | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | months | MEDIAN |
| SECONDARY | All Cohorts: Disease Control Rate (DCR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet) | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Duration of Response (DOR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet) | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Only participants with confirmed CR or PR as BOR were included in the analysis. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | months | MEDIAN |
| SECONDARY | Triplet Cohort: Objective Response Rate | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 113 weeks | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part B (triplet cohort) at both tusamitamab ravtansine doses. | percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Trough Concentration (Ctrough) of Tusamitamab Ravtansine | Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks) | PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | All Cohorts: Ctrough of Pembrolizumab | Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks) | PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | mcg/mL | MEAN |
| SECONDARY | Quadruplet Cohort: Plasma Concentration of Pemetrexed | 30 minutes post-dose on Day 1 of Cycle 1 (cycle duration=3 weeks) | PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | mcg/mL | MEAN |
| SECONDARY | Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion (Ceoi) of Cisplatin | At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks) | PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | mcg/mL | MEAN |
| SECONDARY | Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion of Carboplatin | At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks) | PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | mcg/mL | MEAN |
| SECONDARY | All Cohorts: Number of Participants With Treatment-emergent Anti-Therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet) | ATA population included all participants from the all-treated population with at least 1 post-baseline ATA result (negative, positive, or inconclusive). Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | Participants | COUNT_OF_PARTICIPANTS |
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.
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GET https://conductscience.org/api/trials/v1/NCT04524689/outcomes