A Phase 2 interventional study of Vilobelimab and Vilobelimab + pembrolizumab combination therapy in SCC - Squamous Cell Carcinoma of Skin, sponsored by InflaRx GmbH. Terminated at 25 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by InflaRx GmbH · Phase 2, Interventional, and Treatment
This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms
This is an open-label, non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms (Arm A: Vilobelimab monotherapy; Arm B: Vilobelimab + pembrolizumab combination therapy), both consisting of 2 stages whereas Arm B starts with a safety run in portion. Enrollment follows an optimal Simon's 2-stage design with an interim analysis of treatment response after Stage 1 prior to patient enrollment into Stage 2.
Arm B will start after ≥3 patients have been treated in Arm A and no toxicity concerns have emerged. In a safety run-in part of Arm B, escalating doses of Vilobelimab will be investigated in combination with pembrolizumab in order to identify the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D). Patients will be treated until progression, occurrence of unacceptable toxicity, or treatment discontinuation for any other reason.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →InflaRx GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
In addition to providing the material for ensuring the diagnosis as stated in inclusion criterion 2a for patients with locally advanced cSCC, patients must consent to undergo the following biopsies (at each time point a punch biopsy of externally visible cSCC lesions or a biopsy of material from accessible metastases) for biomarker assessments:
Patients must have the following minimum before first study treatment administration from previous treatments:
Exclusion Criteria:
Patients with previously treated may participate provided they are radiologically stable, i.e., without evidence of progression for ≥4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of treatment for ≥14 days prior to first dose of study treatment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vilobelimab monotherapy; Vilobelimab monotherapy was administered as a 30-minute (-5 / +10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until end of treatment (EOT)
Drug: Vilobelimab
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 400 mg on Days 1, 4, 8, and 15, followed by 800 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
Drug: Vilobelimab + pembrolizumab combination therapy
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 600 mg on Days 1, 4, 8, and 15, followed by 1200 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
Drug: Vilobelimab + pembrolizumab combination therapy
Vilobelimab + pembrolizumab combination therapy; Vilobelimab was administered as a 30-minute (-5/+10 minutes) intravenous infusion as follows: 800 mg on Days 1, 4, 8, and 15, followed by 1600 mg Q2W starting on Day 22 of Cycle 1 until EOT. Vilobelimab treatment was combined with pembrolizumab, administered as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 400 mg starting at Day 8 of Cycle 1 and then Q6W on Day 1 of each treatment cycle
Drug: Vilobelimab + pembrolizumab combination therapy
Vilobelimab Monotherapy
Drug pages: Vilobelimab · Pembrolizumab
Vilobelimab + pembrolizumab combination therapy
Also known as: KEYTRUDA®
Best Overall Response Rate (Best ORR) - Arm A and Arm B
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.
Time frame: Up to 36 months
Dose-limiting Toxicity (DLT) - Arm B
Frequency of dose-limiting toxicities (DLTs) by dose cohort.
Time frame: Cycle 1 Day 1 - Cycle 1 Day 36
Disease Control Rate - Arm A and Arm B
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.
Time frame: Up to 36 months
Progression-free Survival (PFS)- Arm A and Arm B
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.
Time frame: Up to 36 months
Overall Survival (OS)- Arm A and Arm B
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.
Time frame: Up to 36 months
Antidrug Antibodies (ADAs) - Arm A and Arm B
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.
Time frame: Up to 27 months
Quality of Life (QoL) - Arm A and Arm B
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.
Time frame: Up to 36 months
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
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.
Time frame: Up to 36 months
Plasma Concentration of Vilobelimab - Arm A and Arm B
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.
Time frame: Up to 27 months
| Milestone | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: |
|---|---|---|---|---|
| Started | 10 | 3 | 6 | 6 |
| Completed | 1 | 1 | 1 | 1 |
| Not completed | 9 | 2 | 5 | 5 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 |
| Withdrew: Death | 7 | 2 | 4 | 1 |
| Withdrew: Due to premature study termination by sponsor | 2 | 0 | 1 | 3 |
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.
| Participants | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: |
|---|---|---|---|---|
| ORR (Responder) | 1 | 0 | 1 | 2 |
| Non-responder | 9 | 3 | 4 | 4 |
| No post baseline measurement | 0 | 0 | 1 | 0 |
Frequency of dose-limiting toxicities (DLTs) by dose cohort.
| Participants | Arm A: | Arm B Regimen 1: | Arm B Regimen 2: | Arm B Regimen 3: |
|---|---|---|---|---|
| Dose-limiting Toxicity (DLT) - Arm B | 0 | 0 | 0 | 0 |
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.
| Participants | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: |
|---|---|---|---|---|
| Cycle 2 Day 1 — Controlled disease | 2 | 0 | 3 | 4 |
| Cycle 2 Day 1 — No controlled disease | 6 | 1 | 2 | 2 |
| Cycle 2 Day 1 — No response assessment | 2 | 2 | 1 | 0 |
| Cycle 3 Day 1 — Controlled disease | 1 | 0 | 1 | 2 |
| Cycle 3 Day 1 — No controlled disease | 0 | 0 | 1 | 2 |
| Cycle 3 Day 1 — No response assessment | 9 | 3 | 4 | 2 |
| Cycle 3 Day 29 — Controlled disease | 1 | 0 | 0 | 0 |
| Cycle 3 Day 29 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 3 Day 29 — No response assessment | 9 | 3 | 6 | 6 |
| Cycle 4 Day 1 — Controlled disease | 1 | 0 | 1 | 2 |
| Cycle 4 Day 1 — No controlled disease | 0 | 0 | 0 | 1 |
| Cycle 4 Day 1 — No response assessment | 9 | 3 | 5 | 3 |
| Cycle 5 Day 1 — Controlled disease | 2 | 0 | 1 | 2 |
| Cycle 5 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 5 Day 1 — No response assessment | 8 | 3 | 5 | 4 |
| Cycle 6 Day 1 — Controlled disease | 2 | 0 | 1 | 2 |
| Cycle 6 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 6 Day 1 — No response assessment | 8 | 3 | 5 | 4 |
| Cycle 7 Day 1 — Controlled disease | 2 | 0 | 1 | 1 |
| Cycle 7 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 7 Day 1 — No response assessment | 8 | 3 | 5 | 5 |
| Cycle 8 Day 1 — Controlled disease | 1 | 0 | 1 | 0 |
| Cycle 8 Day 1 — No controlled disease | 0 | 0 | 0 | 1 |
| Cycle 8 Day 1 — No response assessment | 9 | 3 | 5 | 5 |
| Cycle 9 Day 1 — Controlled disease | 2 | 0 | 1 | 0 |
| Cycle 9 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 9 Day 1 — No response assessment | 8 | 3 | 5 | 6 |
| Cycle 10 Day 1 — Controlled disease | 1 | 0 | 1 | 0 |
| Cycle 10 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 10 Day 1 — No response assessment | 9 | 3 | 5 | 6 |
| Cycle 11 Day 1 — Controlled disease | 2 | 0 | 1 | 0 |
| Cycle 11 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 11 Day 1 — No response assessment | 8 | 3 | 5 | 6 |
| Cycle 12 Day 1 — Controlled disease | 0 | 0 | 1 | 0 |
| Cycle 12 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 12 Day 1 — No response assessment | 10 | 3 | 5 | 6 |
| Cycle 12 Day 29 — Controlled disease | 1 | 0 | 0 | 0 |
| Cycle 12 Day 29 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 12 Day 29 — No response assessment | 9 | 3 | 6 | 6 |
| Cycle 13 Day 1 — Controlled disease | 0 | 0 | 1 | 0 |
| Cycle 13 Day 1 — No controlled disease | 1 | 0 | 0 | 0 |
| Cycle 13 Day 1 — No response assessment | 9 | 3 | 5 | 6 |
| Cycle 14 Day 1 — Controlled disease | 0 | 0 | 1 | 0 |
| Cycle 14 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 14 Day 1 — No response assessment | 10 | 3 | 5 | 6 |
| Cycle 14 Day 15 — Controlled disease | 0 | 0 | 0 | 0 |
| Cycle 14 Day 15 — No controlled disease | 1 | 0 | 0 | 0 |
| Cycle 14 Day 15 — No response assessment | 9 | 3 | 6 | 6 |
| Cycle 15 Day 1 — Controlled disease | 0 | 0 | 1 | 0 |
| Cycle 15 Day 1 — No controlled disease | 1 | 0 | 0 | 0 |
| Cycle 15 Day 1 — No response assessment | 9 | 3 | 5 | 6 |
| Cycle 16 Day 1 — Controlled disease | 0 | 0 | 1 | 0 |
| Cycle 16 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 16 Day 1 — No response assessment | 10 | 3 | 5 | 6 |
| Cycle 17 Day 1 — Controlled disease | 0 | 0 | 1 | 0 |
| Cycle 17 Day 1 — No controlled disease | 0 | 0 | 0 | 0 |
| Cycle 17 Day 1 — No response assessment | 10 | 3 | 5 | 6 |
| EOT Visit — Controlled disease | 0 | 0 | 1 | 0 |
| EOT Visit — No controlled disease | 3 | 2 | 0 | 3 |
| EOT Visit — No response assessment | 7 | 1 | 5 | 3 |
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.
| days | Arm A: | Arm B Regimen 1: | Arm B Regimen 2: | Arm B Regimen 3: |
|---|---|---|---|---|
| Progression-free Survival (PFS)- Arm A and Arm B | 50.0 (40.0 to 51.0) | 106.0 (43.0 to 106.0) | 90.0 (52.0 to NA) | 87.5 (49.0 to NA) |
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.
| days | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: |
|---|---|---|---|---|
| Overall Survival (OS)- Arm A and Arm B | 285.0 (52.0 to NA) | 106.0 (63.0 to NA) | 300.5 (103.0 to NA) | NA (77.0 to NA) |
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.
| Participants | Arm A: | Arm B Regimen 1: | Arm B Regimen 2: | Arm B Regimen 3: |
|---|---|---|---|---|
| Patients with at least one positive result | 2 | 0 | 0 | 0 |
| Patients without positive result | 8 | 3 | 6 | 6 |
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.
| units on a scale | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: |
|---|---|---|---|---|
| Cycle 2 Day 1 | 0.31 ± 4.38 | -0.80 ± NA | -2.68 ± 3.58 | -3.04 ± 6.21 |
| Cycle 3 Day 1 | -0.35 ± 5.73 | — | 3.00 ± 5.66 | -3.27 ± 1.62 |
| Cycle 4 Day 1 | 1.95 ± 0.21 | — | -2.40 ± NA | -6.35 ± 0.78 |
| Cycle 5 Day 1 | -1.15 ± 2.19 | — | -3.80 ± NA | -3.20 ± 2.83 |
| Cycle 6 Day 1 | 0.75 ± 0.49 | — | -1.40 ± NA | -1.85 ± 2.33 |
| Cycle 7 Day 1 | 2.55 ± 1.63 | — | 1.20 ± NA | -3.50 ± NA |
| Cycle 8 Day 1 | -2.10 ± 8.20 | — | -0.70 ± NA | -3.40 ± NA |
| Cycle 9 Day 1 | -2.10 ± 12.02 | — | -3.40 ± NA | — |
| Cycle 10 Day 1 | 0.20 ± 7.78 | — | -1.10 ± NA | — |
| Cycle 11 Day 1 | -0.75 ± 8.27 | — | — | — |
| Cycle 12 Day 1 | 0.60 ± 7.21 | — | -2.30 ± NA | — |
| Cycle 13 Day 1 | 1.00 ± 5.09 | — | -3.50 ± NA | — |
| Cycle 14 Day 1 | 4.60 ± NA | — | -4.00 ± NA | — |
| Cycle 15 Day 1 | 4.60 ± NA | — | 0.20 ± NA | — |
| Cycle 16 Day 1 | — | — | -5.10 ± NA | — |
| Cycle 17 Day 1 | — | — | -2.30 ± NA | — |
| EOT Visit | -1.67 ± 3.91 | 0.80 ± NA | 1.13 ± 4.14 | -4.67 ± 6.53 |
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.
| days | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: |
|---|---|---|---|---|
| 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 | 490.0 (462.0 to 518.0) | — | NA (43.0 to NA) | 128.0 (43.0 to NA) |
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.
| ng/mL | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: |
|---|---|---|---|---|
| Pre-dose Cycle 1 Day 8 | 128404.2 ± 86.8 | 32488.5 ± 51.9 | 80525.0 ± 41.5 | 88749.9 ± 52.4 |
| Pre-dose Cycle 1 Day 22 | 85088.6 ± 135.8 | 25312.8 ± 94.1 | 72792.5 ± 57.5 | 78248.6 ± 48.6 |
| Post-dose Cycle 1 Day 22 | 514953.9 ± 43.5 | 208865.8 ± 27.6 | 261068.1 ± 96.7 | 210169.5 ± 66.1 |
| Pre-dose Cycle 2 Day 1 | 81260.1 ± 281.2 | 11124.0 ± NA | 48722.9 ± 106.9 | 80697.1 ± 104.1 |
| Pre-dose Cycle 5 Day 1 | 107989.9 ± 43.6 | — | 132497.0 ± NA | 41506.4 ± 65.9 |
Collected over Up to 36 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: | 7/10 (70%) | 7/10 (70%) | 9/10 (90%) |
| Arm B Regimen 1: | 2/3 (66.7%) | 2/3 (66.7%) | 3/3 (100%) |
| Arm B Regimen 2: | 4/6 (66.7%) | 2/6 (33.3%) | 5/6 (83.3%) |
| Arm B Regimen 3: | 1/6 (16.7%) | 1/6 (16.7%) | 6/6 (100%) |
| Event | Arm A: | Arm B Regimen 1: | Arm B Regimen 2: | Arm B Regimen 3: |
|---|---|---|---|---|
| General physical health deteriorationGeneral disorders | 1/10 | 2/3 | 2/6 | 0/6 |
| Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/10 | 1/3 | 0/6 | 0/6 |
| Haemorrhage intracranialNervous system disorders | 0/10 | 0/3 | 0/6 | 1/6 |
| COVID-19 pneumoniaInfections and infestations | 0/10 | 0/3 | 1/6 | 0/6 |
| Pneumonia staphylococcalInfections and infestations | 0/10 | 0/3 | 1/6 | 0/6 |
| Metabolic encephalopathyNervous system disorders | 1/10 | 0/3 | 0/6 | 0/6 |
| PresyncopeNervous system disorders | 1/10 | 0/3 | 0/6 | 0/6 |
| Cardiac FailureCardiac disorders | 1/10 | 0/3 | 0/6 | 0/6 |
| Cardio-respiratory arrestCardiac disorders | 1/10 | 0/3 | 0/6 | 0/6 |
| COVID-19Infections and infestations | 1/10 | 0/3 | 0/6 | 0/6 |
| Event | Arm A: | Arm B Regimen 1: | Arm B Regimen 2: | Arm B Regimen 3: |
|---|---|---|---|---|
| FatigueGeneral disorders | 1/10 | 1/3 | 0/6 | 2/6 |
| PainGeneral disorders | 0/10 | 0/3 | 2/6 | 0/6 |
| Chest painGeneral disorders | 0/10 | 1/3 | 0/6 | 0/6 |
| ConstipationGastrointestinal disorders | 0/10 | 1/3 | 0/6 | 0/6 |
| NasopharyngitisInfections and infestations | 1/10 | 1/3 | 0/6 | 0/6 |
| Urinary tract infectionInfections and infestations | 1/10 | 1/3 | 0/6 | 0/6 |
| Lipase increasedInvestigations | 0/10 | 1/3 | 0/6 | 0/6 |
| SARS-CoV-2 test positiveInvestigations | 0/10 | 1/3 | 0/6 | 0/6 |
| Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/10 | 1/3 | 0/6 | 0/6 |
| Back painMusculoskeletal and connective tissue disorders | 0/10 | 1/3 | 0/6 | 0/6 |
| Age, Continuous(years) | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: | Total |
|---|---|---|---|---|---|
| Mean | 74.0 ± 13.4 | 81.3 ± 13.3 | 72.8 ± 10.6 | 70.8 ± 9.6 | 73.8 ± 11.6 |
| Sex: Female, Male(Participants) | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: | Total |
|---|---|---|---|---|---|
| Female | 5 | 2 | 4 | 5 | 16 |
| Male | 5 | 1 | 2 | 1 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 10 | 3 | 5 | 6 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 0 | 1 |
| White | 9 | 3 | 6 | 6 | 24 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: | Total |
|---|---|---|---|---|---|
| Belgium | 0 | 2 | 1 | 0 | 3 |
| United States | 1 | 0 | 0 | 2 | 3 |
| France | 3 | 1 | 0 | 0 | 4 |
| Germany | 5 | 0 | 3 | 2 | 10 |
| Spain | 1 | 0 | 2 | 2 | 5 |
| Weight at screening(kilogram) | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: | Total |
|---|---|---|---|---|---|
| Mean | 82.56 ± 45.40 | 73.33 ± 21.57 | 71.12 ± 16.44 | 71.48 ± 9.59 | 76.05 ± 30.29 |
| Height at screening(centimeter) | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: | Total |
|---|---|---|---|---|---|
| Mean | 167.7 ± 12.1 | 167.0 ± 2.6 | 160.3 ± 5.9 | 169.0 ± 9.8 | 166.2 ± 9.7 |
| BMI at screening(kg/m²) | Arm A: | Arm B: Regimen 1: | Arm B: Regimen 2: | Arm B: Regimen 3: | Total |
|---|---|---|---|---|---|
| Mean | 29.08 ± 14.18 | 26.13 ± 6.79 | 27.90 ± 7.22 | 25.10 ± 3.48 | 27.49 ± 9.76 |
21 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2021 to primary completion in Jun 2024, 38 months.
Results were first posted in Feb 2025, 8 months after primary completion.
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Studies of the drugs tested here: Vilobelimab · Pembrolizumab
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