Trial · NCT04590326
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose Limiting Toxicities (DLT) | 42 days | Dose escalation phase, Module 1 |
| Primary | Incidence of DLTs | 21 days post combination administration | Dose escalation phase, Module 2 |
| Primary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | Through study completion, up to 5 years | Primary: Dose escalation phase Secondary: Dose expansion phase |
| Primary | Incidence of Serious Adverse Events (SAEs) | Through study completion, up to 5 years | Primary: Dose escalation phase Secondary: Dose expansion phase |
| Primary | Incidence of deaths | Through study completion, up to 5 years | Primary: Dose escalation phase Secondary: Dose expansion phase |
| Primary | Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0]) | Through study completion, up to 5 years | Primary: Dose escalation phase Secondary: Dose expansion phase |
| Primary | Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab | Through study completion, up to 5 years | Primary: Dose escalation phase |
| Primary | Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Eisenhauer, 2009) of REGN5668 in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination) | Through study completion, up to 5 years | Primary: Dose expansion phase |
| Secondary | ORR based on RECIST 1.1 | Through study completion, up to 5 years | Dose escalation phase |
| Secondary | Best Overall Response (BOR) based on RECIST 1.1 | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Duration Of Response (DOR) based on RECIST 1.1 | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Disease Control Rate (DCR) based on RECIST 1.1 | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Progression-Free Survival (PFS) based on RECIST 1.1 | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Cancer Antigen 125 (CA-125) change from baseline after treatment with REGN5668 in combinations with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination) | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Concentration of REGN5668 in serum over time when dosed alone and in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Presence or absence of anti-drug antibodies against REGN5668 | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Presence or absence of anti-drug antibodies against ubamatamab | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Presence or absence of anti-drug antibodies against cemiplimab | Through study completion, up to 5 years | Dose escalation and expansion phases |
| Secondary | Presence or absence of anti-drug antibodies against fianlimab | Through study completion, up to 5 years | Dose escalation and expansion phases |
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/NCT04590326/registered