Trial · NCT04663347
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Dose limiting Toxicities (DLTs) | During the first cycle (Cycle length= 28 days) in each cohort | DLT events are defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0. |
| Primary | Part 1 and Part 2 (Arms 1-5, 7 and 10): Number of Participants With Adverse Events (AEs) | From first dose of drug until either 60 days after last dose, date participant withdraws consent, date participant starts a new systemic anticancer therapy, or date participant dies, whichever occurs first (up to approximately 3 years) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Primary | Part 2 (Except Arm 7): Overall Response Rate (ORR) | Up to 3 years | ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria. |
| Secondary | Part 1 and 2: Clearance (CL) of Epcoritamab | Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) | |
| Secondary | Part 1 and 2: Area Under the Concentration-Time Curve (AUC) of Epcoritamab | Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) | |
| Secondary | Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab | Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) | |
| Secondary | Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab | Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) | |
| Secondary | Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab | Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years) | |
| Secondary | Part 1 and 2: Number of Immune Cell Populations | Up to 2 years | Immune cell populations in peripheral blood and tumor biopsies will be assessed. |
| Secondary | Part 1 and 2: Percentage of Immune Cell Populations | Up to 2 years | Immune cell populations in peripheral blood and tumor biopsies will be assessed. |
| Secondary | Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3 | Up to Cycle 3 (cycle length = 21 days for Arms 1, 4, 8 and 10; cycle length = 28 days for Arms 2, 3, 5, 6 and 9; cycle length = 28 days (Cycle 1) and 56 days (Cycles 2, 3) for Arm 7) | Change in cytokine levels in peripheral blood samples will be assessed. |
| Secondary | Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years) | Up to 2 years | Change in circulating tumor DNA levels will be assessed. |
| Secondary | Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab | Up to 3 years | |
| Secondary | Part 1: ORR | Up to 3 years | ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria. |
| Secondary | Part 1 and 2: Duration of Response (DOR) | Up to 3 years | DOR: the time from the first documentation of objective tumor response (CR or PR) to the date of first PD or death, whichever occurs earlier, based on Lugano criteria. |
| Secondary | Part 1 and 2: Time to Response (TTR) | Up to 3 years | TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR). |
| Secondary | Part 1 and 2: Progression Free Survival (PFS) | Up to 3 years | PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier, based on Lugano criteria. |
| Secondary | Part 1 and 2: Overall Survival (OS) | Up to 3 years | OS is defined as the time from the date of first dose, to the date of death due to any cause. |
| Secondary | Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT) | Up to 3 years | TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy. |
| Secondary | Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity | Up to 3 years | It is defined as the percentage of participants with at least 1 MRD negative result. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04663347/registered