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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-A93 | Other Identifier | Merck Sharp & Dohme LLC | |
| KEYNOTE-A93 | Other Identifier | Merck Sharp & Dohme LLC | |
| 2020-000864-42 | EudraCT Number |
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Sponsor decided to stop the development of vilobelimab in cSCC and early terminated the IFX-1-P2.8 trial due to new alternative treatments for cSCC with high efficacy rates.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: | Experimental | 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) |
|
| Arm B: Regimen 1: | Experimental | 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 |
|
| Arm B: Regimen 2: | Experimental | 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 |
|
| Arm B: Regimen 3: | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilobelimab | Drug | Vilobelimab Monotherapy |
| |
| Vilobelimab + pembrolizumab combination therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 36 months |
| Dose-limiting Toxicity (DLT) - Arm B | Frequency of dose-limiting toxicities (DLTs) by dose cohort. | Cycle 1 Day 1 - Cycle 1 Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 36 months |
| Progression-free Survival (PFS)- Arm A and Arm B |
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Inclusion Criteria:
At least 18 years of age on day of signing informed consent
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. All patients to be included must have progressed on PD-1- or PD-L1-inhibitory antibody therapy.
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:
The PD-1-/PD-L1 infusion must have been the most recent treatment for locally advanced or metastatic cSCC.
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 washout before first study treatment administration from previous treatments:
Eastern Cooperative Oncology Group performance status (ECOG PS) status of ≤1
Adequate organ function
Patient (or legally acceptable representative if applicable) provides written informed consent for the study.
Exclusion Criteria:
Patients with previously treated brain metastases 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 steroid treatment for ≥14 days prior to first dose of study treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. D. Schadendorf, MD | University Hospital, Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States | ||
| Anschutz Cancer Pavilion |
According to protocol stipulations, a participant is enrolled into the study if informed consent form is completed (signed and dated). This reflects the "Protocol Enrollment: 30" participant number. Five (5) participants failed screening (after ICF signed) and were not assigned to and treated in the different Arms/Groups, constituting the "Total Started in Participant Flow: 25" participant number.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: | 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 EOT |
| FG001 | Arm B: Regimen 1: |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2021 |
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Arm A: Vilobelimab monotherapy; Arm B: Vilobelimab + in combination with approved dosing scheme of pembrolizumab
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|
| Drug |
Vilobelimab + pembrolizumab combination therapy |
|
|
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. |
| 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. | 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. | 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. | 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. | 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. | Up to 27 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Orlando Health, Inc. | Orlando | Florida | 32806 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
| University Hospital Antwerp (UZA) | Edegem | 2650 | Belgium |
| St. Augustinus Hospital | Wilrijk | 2610 | Belgium |
| University Hospital Center of Grenoble Alpes, Department of Dermatology | Grenoble | 38700 | France |
| South Lyon Hospital Center | Lyon | 69495 | France |
| CHU APHM la Timone / Aix Marseille University, Dermatology and Skin Cancer Department | Marseille | 13385 | France |
| St. Louis Hospital | Paris | 75010 | France |
| University Hospital Center of Poitiers, Department of Oncology | Poitiers | 86021 | France |
| University Hospital Erlangen, Department of Dermatology | Erlangen | 91054 | Germany |
| University Duisburg-Essen, University Hospital Essen, Department of Dermatology | Essen | 45147 | Germany |
| Frankfurt University Clinic, Department of Dermatology, Venereology and Allergology | Frankfurt | 60590 | Germany |
| University Hospital Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| University Hospital Leipzig, Department of Dermatology, Venereology and Allergology | Leipzig | 04103 | Germany |
| University Hospital Regensburg, Clinic and Policlinic for Dermatology | Regensburg | 93053 | Germany |
| University Hospital Tuebingen, Department of Dermatology | Tübingen | 72076 | Germany |
| University Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| ICO Hospitalet | Barcelona | 08908 | Spain |
| MD Anderson International Cancer Center Spain | Madrid | 28033 | Spain |
| Regional University Hospital of Malaga | Málaga | 29010 | Spain |
| University Clinical Hospital of Salamanca | Salamanca | 37007 | Spain |
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 |
| FG002 | Arm B: Regimen 2: | 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 |
| FG003 | Arm B: Regimen 3: | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: | 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 EOT |
| BG001 | Arm B: Regimen 1: | 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 |
| BG002 | Arm B: Regimen 2: | 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 |
| BG003 | Arm B: Regimen 3: | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Weight at screening | Mean | Standard Deviation | kilogram |
| |||||||||||||||
| Height at screening | Mean | Standard Deviation | centimeter |
| |||||||||||||||
| BMI at screening | Mean | Standard Deviation | kg/m² |
| |||||||||||||||
| Duration of cSCC | Mean | Standard Deviation | years |
| |||||||||||||||
| Primary diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Tumor category (TNM staging at initial diagnosis) | Primary diagnosis: Metastatic cSCC was considered worse outcome as compared to Locally advanced cSCC according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version) and AJCC TNM Staging Classification, 8th Ed., 2017. Tumor category (TNM staging at initial diagnosis): ascending T categories from TX to T4 were considered increasing worse outcome according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version) and AJCC TNM Staging Classification, 8th Ed., 2017. | Count of Participants | Participants |
| |||||||||||||||
| Nodes (TNM staging at initial diagnosis) | Nodes (TNM staging at initial diagnosis): ascending N categories from NX to N3 were considered increasing worse outcome according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version) and AJCC TNM Staging Classification, 8th Ed., 2017. | Count of Participants | Participants |
| |||||||||||||||
| Metastases (TNM staging at initial diagnosis) | Metastasis (TNM staging at initial diagnosis): ascending M categories from M0 to M1 were considered increasing worse outcome according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version) and AJCC TNM Staging Classification, 8th Ed., 2017. | Count of Participants | Participants |
| |||||||||||||||
| Histologic grade (TNM staging at initial diagnosis) | Histologic grade (TNM staging at initial diagnosis): ascending G categories from GX to G4 were considered increasing worse outcome according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version) and AJCC TNM Staging Classification, 8th Ed., 2017. | Count of Participants | Participants |
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| Prognostic stage group | Prognostic stage group table, comparing TNM staging at initial diagnosis versus TNM staging at study entry: ascending stage categories from Stage 0 to Stage IV were considered increasing worse outcome according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version) and AJCC TNM Staging Classification, 8th Ed., 2017. | Count of Participants | Participants |
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| Prognostic staging system | Prognostic staging system table: 4 prognostic staging systems (AJCC8, AJCC 7, BHW, Other) according to which cSCC TNM staging at initial diagnosis versus TNM staging at study entry were performed. | Count of Participants | Participants |
| |||||||||||||||
| H&P Location/size - area L | H&P Location/size - area L table: Split into risk groups according to disease history and physical parameters (H&P) Location/size for area L (low risk: trunk, extremities) defined by < 20 mm and >= 20 mm according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version). | Count of Participants | Participants |
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| H&P Location/size - area M | H&P Location/size - area M table: Split into risk groups according to disease history and physical parameters (H&P) Location/size for area M (medium risk: cheeks, forehead, neck, scalp) defined by < 10 mm and >= 10 mm according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version). | Count of Participants | Participants |
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| H&P Location/size - area H | H&P Location/size - area H table: Split into risk groups according to disease history and physical parameters (H&P) Location/size for area H (high risk: face, ears, genitals, hands, feet) defined by 'No' and 'Yes' according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version). | Count of Participants | Participants |
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| H&P Borders | H&P Borders table: Split into risk groups according to cSCC lesion borders defined by 'Well defined' (low risk) and 'Poorly defined' (high risk) according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version). | Count of Participants | Participants |
| |||||||||||||||
| H&P Primary vs recurrent | H&P Primary vs recurrent table: Split into risk groups according to primary versus recurrent cSCC disease defined by 'Primary' (low risk) and 'Recurrent' (high risk) according to NCCN Guidelines Squamous Cell Skin Cancer V1.2024 (latest version). | Count of Participants | Participants |
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| H&P Immunosuppression | Count of Participants | Participants |
| ||||||||||||||||
| H&P Site of prior RT or chronic inflammatory process | Count of Participants | Participants |
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| H&P Rapidly growing tumour | Count of Participants | Participants |
| ||||||||||||||||
| H&P Neurologic symptoms | Count of Participants | Participants |
| ||||||||||||||||
| Pathology Degree of differentiation | Count of Participants | Participants |
| ||||||||||||||||
| Pathology Acantholytic, adenosquamous, desmoplastic, or metaplastic subtypes | Count of Participants | Participants |
| ||||||||||||||||
| Pathology Depth: thickness or level of invasion | Count of Participants | Participants |
| ||||||||||||||||
| Pathology Perineural, lymphatic or vascular involvement | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 36 months |
|
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| Primary | Dose-limiting Toxicity (DLT) - Arm B | Frequency of dose-limiting toxicities (DLTs) by dose cohort. | Posted | Count of Participants | Participants | Cycle 1 Day 1 - Cycle 1 Day 36 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Up to 36 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | 95% Confidence Interval | days | Up to 36 months |
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| Secondary | 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. | Posted | Median | 95% Confidence Interval | days | Up to 36 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | Up to 27 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 36 months |
| ||||||||||||||||||||||||||||||||||||
| 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 | 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. | 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. | Posted | Median | 95% Confidence Interval | days | Up to 36 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to 27 months |
|
Up to 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: | 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 EOT | 7 | 10 | 7 | 10 | 9 | 10 |
| EG001 | Arm B Regimen 1: | 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 | 2 | 3 | 2 | 3 | 3 | 3 |
| EG002 | Arm B Regimen 2: | 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 | 4 | 6 | 2 | 6 | 5 | 6 |
| EG003 | Arm B Regimen 3: | 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 | 1 | 6 | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General physical health deterioration | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Amyloidosis | Immune system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Infusion site paraesthesia | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dental discomfort | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Oral hyperkeratosis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Wound infection pseudomonas | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Rash maculo papular | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Skin discharge | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Osteoradionecrosis | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Traumatic haematome | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Skin neoplasm bleeding | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Lymphorrhoea | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Scalp haematoma | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (27.0) | Systematic Assessment |
|
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).
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Camilla Chong, CMO | InflaRx GmbH | +49 3641-508-180 | camilla.chong@inflarx.com |
| Dec 20, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706656 | vilobelimab |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| France |
|
| Germany |
|
| Spain |
|
| Metastatic cSCC |
|
| Tis |
|
| T1 |
|
| T2 |
|
| T3 |
|
| T4 |
|
| N0 |
|
| N1 |
|
| N2 |
|
| N3 |
|
| M1 |
|
| G1 |
|
| G2 |
|
| G3 |
|
| G4 |
|
| Missing |
|
| Stage I |
|
| Stage II |
|
| Stage III |
|
| Stage IV |
|
| Missing |
|
| TNM staging at study entry |
|
| AJCC 7 |
|
| BHW |
|
| Other |
|
| Missing |
|
| TNM staging at study entry |
|
| >=20 mm |
|
| Missing |
|
| >=10 mm |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Poorly defined |
|
| Missing |
|
| Recurrent |
|
| Missing |
|
| + |
|
| Missing |
|
| + |
|
| Missing |
|
| + |
|
| Missing |
|
| + |
|
| Missing |
|
| Poorly differentiated |
|
| Missing |
|
| + |
|
| Missing |
|
| >6 mm or invasion beyond subcutaneous fat |
|
| Missing |
|
| + |
|
| Missing |
|
| Non-responder |
|
| No post baseline measurement |
|
| OG003 | Arm B Regimen 3: | 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 |
|
|
| OG003 | Arm B: Regimen 3: | 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 |
|
|
| OG003 | Arm B Regimen 3: | 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 |
|
|
| OG003 | Arm B: Regimen 3: | 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 |
|
|
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
| OG003 | Arm B Regimen 3: | 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 |
|
|
| OG002 | Arm B: Regimen 2: | 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 |
| OG003 | Arm B: Regimen 3: | 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 |
|
|
| OG002 | Arm B: Regimen 2: | 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 |
| OG003 | Arm B: Regimen 3: | 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 |
|
|
| OG002 | Arm B: Regimen 2: | 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 |
| OG003 | Arm B: Regimen 3: | 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 |
|
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
| No controlled disease |
|
| No response assessment |
|
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