Trial · NCT04590326
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
NCT04590326, Phase 1, Phase 2, Recruiting, Regeneron Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab. Trials, record NCT04590326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04590326
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
- NCT number
- NCT04590326
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 612 participants, estimated
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Endometrial Cancer
- Interventions
- REGN5668, Cemiplimab, Ubamatamab, Sarilumab, Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
- First posted
- 2020-10-19
- Last updated
- 2026-09-24
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04590326
GET https://conductscience.org/api/trials/v1/NCT04590326/registered