Trial · NCT05729139
Cemiplimab/Peg-Interferon-α in Advanced CSCC
NCT05729139, Phase 1, Withdrawn, Baptist Health South Florida
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cemiplimab/Peg-Interferon-α in Advanced CSCC. Trials, record NCT05729139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05729139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cemiplimab/Peg-Interferon-α in Advanced CSCC
- NCT number
- NCT05729139
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Baptist Health South Florida
- Conditions
- Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma, Advanced Squamous Cell Carcinoma
- Interventions
- Cemiplimab-Rwlc, PEG-IFN alfa-2a
- First posted
- 2023-02-15
- Last updated
- 2023-08-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Incidence of Dose Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) Leading to Discontinuation or Death | 2 years | DLT rate by dose level, frequency distribution of treated participants with AE using the worst common terminology criteria grade. Participants will be counted only (1) once at the preferred term level, (2) once at the system organ class level, and (3) once in the "total participant" row at their worst common terminology criteria grade, regardless of system organ class or preferred term. The DLT window of observation will be during treatment cycle 1 only (i.e., during the first 21-day cycle; adverse events (AEs) meeting the definition of a DLT but occurring after this period will not be considered DLTs). The occurrence of certain toxicities during treatment cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to PEG-IFN-α and/or cemiplimab. |
| Secondary | Response Rate (RR) | 2 years | RR is defined as the proportion of participants whose best overall response is complete (CR) or partial (PR). |
| Secondary | Duration of Response (DOR) | 2 years | DOR is defined as the amount of time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first in participants who had achieved CR or PR. |
| Secondary | Progression-free Survival (PFS) | 2 years | PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first |
| Secondary | Overall Survival (OS) | 2 years | OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT05729139
GET https://conductscience.org/api/trials/v1/NCT05729139/registered