Trial · NCT05556616
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs) | Cycle 1 (Cycle length is 28 days) | The DLT-evaluable Analysis Set included participants who experienced a DLT in Cycle 1 in the treatment phase of the study or completed Cycle 1 procedures and received a full Cycle 1 dose of modakafusp alfa and at least 75% of the planned dose of the combination partner. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | Up to 16.7 months | The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Up to 16.7 months | |||
| SECONDARY | Overall Response Rate (ORR) | Up to 16.7 months | Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline \& at least 1 post-baseline efficacy evaluation. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Overall Survival (OS) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Time to Progression (TTP) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Time to Next Treatment (TTNT) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Disease Control Rate (DCR) | Up to 16.7 months | The Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline and at least 1 post-baseline efficacy evaluation. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled the criteria for the Response-Evaluable Analysis Set and hence are not presented here. | percentage of participants | NUMBER |
| SECONDARY | Groups 2 and 3: Event-free Survival (EFS) | Up to 16.7 months | |||
| SECONDARY | Groups 2 and 3: Time to Response (TTR) | Up to 16.7 months | |||
| SECONDARY | Group 1: Percentage of Participants With MRD Negativity Status at a Threshold of 10^-5 | At 6 months, 1 year, and 2 years after the start of treatment | MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., being on study at 6 months). | ||
| SECONDARY | Groups 2 and 3: Percentage of Participants With MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator | Up to 2 years after CR confirmation | MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response). | ||
| SECONDARY | Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity | Up to 2 years after treatment | MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response). | ||
| SECONDARY | Group 2 and 3: Percentage of Participants With MRD Negativity Status at a Threshold of 10^-5 | Up to 16.7 months | MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response). | ||
| SECONDARY | Groups 2 and 3: Duration of MRD Negativity Status at a Sensitivity Threshold of 10^-5 in Participants Achieving MRD Negativity | Up to 16.7 months | MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response). | ||
| SECONDARY | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb) | Up to 16.7 months |
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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