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Monoclonal Antibodies

IFX-1 Alone or Combined with Pembrolizumab for Skin Cancer

Phase 2
Waitlist Available
Led By Prof. Dr. D. Schadendorf, MD
Research Sponsored by InflaRx GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with biopsy-proven, histologically or cytologically confirmed (a.) locally advanced cSCC not amenable for curative treatment or (b.) metastatic cSCC. Patients must have been treated with all approved therapies for (a.) inoperable locally advanced cSCC contraindicated for radiation therapy or (b.) metastatic cSCC
At least 18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial has two groups of patients receiving different treatments to see if either is effective in treating the disease.

Who is the study for?
This trial is for adults over 18 with advanced or metastatic cSCC who have not responded to anti-PD-1/L1 therapy and can't be cured by surgery or radiation. They must be relatively healthy (ECOG PS ≤1) and not have had other cancers in the last 5 years, no severe immune conditions, recent surgeries, active brain metastases, infections, heart failure, or be pregnant.Check my eligibility
What is being tested?
The study tests IFX-1 alone or combined with pembrolizumab in patients whose cSCC has worsened despite previous treatments. It's an open-label Phase II trial where participants are openly assigned to one of two treatment groups without randomization.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs' components, infusion-related reactions similar to those from other monoclonal antibodies which could range from mild discomfort to more serious symptoms depending on individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced or metastatic skin cancer and cannot be cured with surgery or radiation.
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I am at least 18 years old.
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My cancer has worsened despite treatment with specific immune therapy.
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I can carry out all my self-care but not work activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DLT- Arm B
ORR- Arm A
ORR- Arm B
+1 more
Secondary outcome measures
ADAs against IFX-1 - Arm B
ADAs- Arm A
Disease control rate - Arm A
+9 more

Side effects data

From 2020 Phase 2 trial • 179 Patients • NCT03487276
12%
Nasopharyngitis
12%
Hidradenitis
12%
Diarrhoea
12%
Headache
9%
Pain of skin
6%
Viral upper respiratory tract infection
6%
Pyrexia
6%
Vomiting
6%
Nausea
6%
Dyspepsia
6%
Pain in extremity
6%
Foot fracture
3%
Back pain
3%
Abscess
3%
Pharyngitis
3%
Bronchitis
3%
Upper respiratory tract infection
3%
Gastrooesophageal reflux disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Main Period: Cohort 2
Extension Period: Cohort 3
Main Period: Cohort 4
Main Period: Cohort 1
Main Period: Cohort 5
Extension Period: Cohort 4
Main Period: Cohort 3

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: IFX-1 + pembrolizumab combination therapyExperimental Treatment1 Intervention
IFX-1 + pembrolizumab combination therapy
Group II: Arm A: IFX-1 monotherapyExperimental Treatment1 Intervention
IFX-1 monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IFX-1
2018
Completed Phase 2
~370

Find a Location

Who is running the clinical trial?

InflaRx GmbHLead Sponsor
10 Previous Clinical Trials
990 Total Patients Enrolled
Prof. Dr. D. Schadendorf, MDPrincipal InvestigatorUniversity Hospital, Essen

Media Library

IFX-1 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04812535 — Phase 2
Systemic Scleroderma Research Study Groups: Arm A: IFX-1 monotherapy, Arm B: IFX-1 + pembrolizumab combination therapy
Systemic Scleroderma Clinical Trial 2023: IFX-1 Highlights & Side Effects. Trial Name: NCT04812535 — Phase 2
IFX-1 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04812535 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what maladies is IFX-1 commonly prescribed?

"IFX-1 may be utilized to treat malignant tumours, inoperable melanoma, and cases of high microsatellite instability."

Answered by AI

In how many distinct locations is this clinical trial currently taking place?

"This medical study is currently utilizing 6 clinical trial sites, located in Fairfax, La Jolla and Aurora amongst other locations. It is prudent to pick the closest centre so as to lessen any travelling demands if you are accepted into the program."

Answered by AI

How has IFX-1 been evaluated in past research?

"Currently, 961 medical experiments are underway investigating the effects of IFX-1. Of these ongoing studies, 122 have reached Phase 3 status. Although a majority of trials for this drug occur in Houston, Texas there are over 35 thousand sites running tests on it globally."

Answered by AI

What is the size of the cohort involved in this research?

"This medical study necessitates the enrolment of 70 individuals that meet its specific inclusion criteria. These volunteers can register with Inova Schar Cancer Institute in Fairfax, Virginia or UC San Diego Moores Cancer Center in La Jolla, California."

Answered by AI

What would the outcomes of this experiment indicate?

"This medical study has a 36-month duration, with its primary goal being to measure TEAEs of Arm B. Secondary objectives include Response (CR/iCR/PR/iPR) and SD -Arm B; OS - Arm A; and PFS - Arm B."

Answered by AI

Is the intake process for this medical experiment still open?

"Affirmative. According to clinicaltrials.gov, this experiment is currently enrolling participants, with the initial posting on June 1st 2021 and most recent update being November 10th 2022. 70 individuals between 6 different sites are sought after for this trial."

Answered by AI

What adverse effects are associated with IFX-1?

"Our internal evaluation gave IFX-1 a safety rating of 2 as there is existing data that suggest its safety, but no studies have been conducted to assess efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
2021. "Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04812535.
~18 spots leftby Apr 2025
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