Trial · NCT04812535
Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
NCT04812535, Phase 2, Terminated, InflaRx GmbH; results first posted 2025-02-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC. Trials, record NCT04812535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04812535
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
- NCT number
- NCT04812535
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- InflaRx GmbH
- Conditions
- SCC - Squamous Cell Carcinoma of Skin
- Interventions
- Vilobelimab, Vilobelimab + pembrolizumab combination therapy
- First posted
- 2021-03-23
- Last updated
- 2025-02-11
- Other registries' IDs
- eudract:2020-000864-42
- Results first posted
- 2025-02-11
- Limitations and caveats
The study was prematurely terminated due to a strategic decision by the sponsor. Therefore, the total number of participants enrolled is smaller than planned (actually enrolled and treated: 25, planned: 70).
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate (Best ORR) - Arm A and Arm B | Up to 36 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immunologic RECIST (iRECIST) for target lesions and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the diameters of target lesions; Best Overall Response (OR) = CR + PR, from the start of the treatment until PD/recurrence. |
| Primary | Dose-limiting Toxicity (DLT) - Arm B | Cycle 1 Day 1 - Cycle 1 Day 36 | Frequency of dose-limiting toxicities (DLTs) by dose cohort. |
| Secondary | Disease Control Rate - Arm A and Arm B | Up to 36 months | Disease control rate is defined as the relative number of patients achieving stable disease (SD/iSD), CR/iCR or PR/iPR according to modified RECIST v1.1 (including clinical response)/iRECIST response. |
| Secondary | Progression-free Survival (PFS)- Arm A and Arm B | Up to 36 months | PFS is defined as the time from first study treatment administration to progression (i.e. PD, iUPD, iCPD) or death. Patients without progression are censored at their last visit/study treatment administration. |
| Secondary | Overall Survival (OS)- Arm A and Arm B | Up to 36 months | Overall survival is defined as the time from first study treatment administration to death. Patients alive when they discontinue the study are censored at their last recorded date of being alive. |
| Secondary | Antidrug Antibodies (ADAs) - Arm A and Arm B | Up to 27 months | Development of human antidrug antibodies (ADAs) against Vilobelimab. In contrast to the time frame of the secondary efficacy outcome measures (3.-5., 7.-8), which were reported until EOS (up to 36 months), the time frames of ADAs (6.) and PK (9.) are measured (only) until first FU. Therefore, the time frame is different, i.e. 24 months of treatment until EOT + (approx.) 12 weeks/3 months until first FU up to 27 months. |
| Secondary | Quality of Life (QoL) - Arm A and Arm B | Up to 36 months | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 version 3.0 measures the different aspects that define the quality of life of cancer patients or survivors. The reported total score ranges from 0 to 100 whereas a higher score represents a higher response level. The total score was calculated as mean of all 15 single scores. It was only calculated if all 15 single scores were non-missing (for more information see Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.). The absolute changes from baseline are presented. |
| Secondary | Response (Complete Response (CR) / CR According to iRECIST (iCR) / Partial Response (PR) / PR According to iRECIST (iPR)) and Stable Disease (SD) Duration - Arm A and Arm B | Up to 36 months | Duration of stable disease is defined as the time from first diagnosis of response or stable disease (i.e., CR/iCR/PR/iPR/SD/iSD) to progression (i.e. progressive disease (PD), unconfirmed progressive disease according to iRECIST (iUPD), confirmed progressive disease (iCPD)) or death. Responding and stable patients without progression are censored at their last visit/study treatment administration. Patients who never respond or have a stable disease are excluded from this analysis. |
| Secondary | Plasma Concentration of Vilobelimab - Arm A and Arm B | Up to 27 months | The plasma concentration of vilobelimab was assessed at different time points pre- and post-dose. The post-dose Cycle 1 Day 22 values correspond to Cmax and the pre-dose Cycle 1 Day 8, pre-dose Cycle 1 Day 22, pre-dose Cycle 2 Day 1 and per-dose Cycle 5 Day 1 values to Ctrough. In contrast to the time frame of the secondary efficacy outcome measures (3.-5., 7.-8), which were reported until EOS (up to 36 months), the time frames of ADAs (6.) and PK (9.) are measured (only) until first FU. Therefore, the time frame is different, i.e. 24 months of treatment until EOT + (approx.) 12 weeks/3 months until first FU up to 27 months. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate (Best ORR) - Arm A and Arm B | Up to 36 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Dose-limiting Toxicity (DLT) - Arm B | Cycle 1 Day 1 - Cycle 1 Day 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Control Rate - Arm A and Arm B | Up to 36 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS)- Arm A and Arm B | Up to 36 months | days | MEDIAN | |
| SECONDARY | Overall Survival (OS)- Arm A and Arm B | Up to 36 months | days | MEDIAN | |
| SECONDARY | Antidrug Antibodies (ADAs) - Arm A and Arm B | Up to 27 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Life (QoL) - Arm A and Arm B | Up to 36 months | Not all patients are analyzed at each visit as the values for these patients are missing. This reason for this is either that the values for these patients are missing in the data or that these patients have already discontinued the study. | units on a scale | MEAN |
| SECONDARY | Response (Complete Response (CR) / CR According to iRECIST (iCR) / Partial Response (PR) / PR According to iRECIST (iPR)) and Stable Disease (SD) Duration - Arm A and Arm B | Up to 36 months | Only patients with response were analyzed. As in Arm B: Regimen 1: there was no patient with a response, the overall number of participants analyzed is 0. | days | MEDIAN |
| SECONDARY | Plasma Concentration of Vilobelimab - Arm A and Arm B | Up to 27 months | Not all patients are analyzed at each visit as the values for these patients are missing. This reason for this is either that the values for these patients are missing in the data or that these patients have already discontinued the study. | ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group335
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm A: | ORR (Responder) | 1 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm B: Regimen 1: | ORR (Responder) | 0 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm B: Regimen 2: | ORR (Responder) | 1 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm B: Regimen 3: | ORR (Responder) | 2 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm A: | Non-responder | 9 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm B: Regimen 1: | Non-responder | 3 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm B: Regimen 2: | Non-responder | 4 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm B: Regimen 3: | Non-responder | 4 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm A: | No post baseline measurement | 0 | Participants | |
| Best Overall Response Rate (Best ORR) - Arm A and Arm B | Arm B: Regimen 1: | No post baseline measurement | 0 | Participants |
1 to 10 of 335Source ClinicalTrials.gov
See all 335 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: | 10 | |
| Overall Study | STARTED | Arm B: Regimen 1: | 3 | |
| Overall Study | STARTED | Arm B: Regimen 2: | 6 | |
| Overall Study | STARTED | Arm B: Regimen 3: | 6 | |
| Overall Study | COMPLETED | Arm A: | 1 | |
| Overall Study | COMPLETED | Arm B: Regimen 1: | 1 | |
| Overall Study | COMPLETED | Arm B: Regimen 2: | 1 | |
| Overall Study | COMPLETED | Arm B: Regimen 3: | 1 | |
| Overall Study | NOT COMPLETED | Arm A: | 9 | |
| Overall Study | NOT COMPLETED | Arm B: Regimen 1: | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events400
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Arm A: | 1 | 10 | 1 |
| other | Fatigue | General disorders | Arm B Regimen 1: | 1 | 3 | 1 |
| other | Fatigue | General disorders | Arm B Regimen 2: | 0 | 6 | 0 |
| other | Fatigue | General disorders | Arm B Regimen 3: | 2 | 6 | 2 |
| other | Asthenia | General disorders | Arm A: | 2 | 10 | 2 |
| other | Asthenia | General disorders | Arm B Regimen 1: | 0 | 3 | 0 |
| other | Asthenia | General disorders | Arm B Regimen 2: | 1 | 6 | 2 |
| other | Asthenia | General disorders | Arm B Regimen 3: | 0 | 6 | 0 |
| other | Pain | General disorders | Arm A: | 0 | 10 | 0 |
| other | Pain | General disorders | Arm B Regimen 1: | 0 | 3 | 0 |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: | 7 | 10 |
| Total, all-cause mortality | Arm B Regimen 1: | 2 | 3 |
| Total, all-cause mortality | Arm B Regimen 2: | 4 | 6 |
| Total, all-cause mortality | Arm B Regimen 3: | 1 | 6 |
| Total, other adverse events | Arm A: | 9 | 10 |
| Total, other adverse events | Arm B Regimen 1: | 3 | 3 |
| Total, other adverse events | Arm B Regimen 2: | 5 | 6 |
| Total, other adverse events | Arm B Regimen 3: | 6 | 6 |
| Total, serious adverse events | Arm A: | 7 | 10 |
| Total, serious adverse events | Arm B Regimen 1: | 2 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT04812535
GET https://conductscience.org/api/trials/v1/NCT04812535/results?page=2