A Phase 1 interventional study of Avelumab 3 mg/kg Q2W and Avelumab 10 mg/kg Q2W in Metastatic Solid Tumors, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Treatment
The purpose of this study was to evaluate the maximum tolerated dose (MTD) and pharmacokinetics (PK) of Avelumab monotherapy in Chinese subjects.
Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
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.
Exclusion Criteria:
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.
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 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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Drug: Avelumab 3 mg/kg Q2W
Drug: Avelumab 10 mg/kg Q2W
Drug: Avelumab 20 mg/kg Q2W
Drug: Avelumab 10 mg/kg QW
Drug page: Avelumab
Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks (Q2W) until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.
Also known as: MSB0010718C
Drug page: Avelumab
Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg Q2W until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.
Drug page: Avelumab
Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg Q2W until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.
Drug page: Avelumab
Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg every week (QW) for the first 12 weeks followed by once every 2 weeks, started at Week 13 until disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or from Avelumab occurs.
Number of Participants With of Dose-limiting Toxicities (DLTs) According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03
DLT is defined as greater than or equal to \[\>=\] Grade (Gr)3 Adverse drug reaction (ADR) according to NCI-CTCAE v4.03, occurring during DLT observation period of dose escalation cohorts. ADR: any AE suspected to be related to avelumab by Investigator and/Sponsor. Following events were not considered as DLT: Gr3 infusion-related reaction resolving within 6 hours and controlled with medical management. Transient (less than or equal to \[\<=\] 6 hours) Gr3 flu-like symptoms/fever, controlled with medical management. Transient (\<=24 hours) Gr3 fatigue, local reactions, headache, nausea, emesis, resolves to \<= Gr1. Gr3 skin toxicity/Gr3 Liver function test increase that resolves to \<= Grade 1 in \< 7 days after medical management. Gr3 diarrhea, out-of-range laboratory values without any clinical correlate that resolves to \<= Grade 1 within 7 days with adequate medical management; Tumor flare phenomenon defined as local pain, irritation, rash localized at sites of known or suspected tumor.
Time frame: Day 1 to Day 21
Area Under the Serum Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Avelumab
Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Avelumab
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Avelumab
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Terminal Elimination Rate Constant (Lambda z) of Avelumab
Lambda z was determined from the terminal slope of the log-transformed serum concentration curve using linear regression method.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Maximum Observed Serum Concentration (Cmax) of Avelumab
Cmax was obtained directly from the serum concentration versus time curve.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Last Quantifiable Serum Concentration (Clast) of Avelumab
Clast is the last measurable serum concentration of Avelumab.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Serum Trough Concentration Levels (Ctrough) of Avelumab
Ctrough is defined as the concentration observed immediately before next dosing.
Time frame: Day 1: within 2 hours prior to 1 hour infusion
Time to Reach Maximum Observed Serum Concentration (Tmax) of Avelumab
The time to reach the maximum observed serum concentration (tmax) was obtained directly from the concentration versus time curve.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Apparent Terminal Half Life (t1/2) of Avelumab
Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. t1/2 was calculated as log2/ lambda z. Lambda z was determined from the terminal slope of the log-transformed serum concentration curve using linear regression method.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Dose Normalized Area Under the Serum Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of Avelumab
AUC0-t/Dose was defined as area under the serum concentration versus time curve from time of dosing to the time of the last measurable concentration divided by dose. AUC0-t/Dose was measured in (microgram\*hour per milliliter)/(milligram per kilogram) (mcg\*h/mL)/(mg/kg).
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Dose Normalized Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau/Dose) of Avelumab
AUCtau/Dose was calculated by as dose normalized area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Dose Normalized Maximum Observed Serum Concentration (Cmax/Dose) of Avelumab
Cmax/Dose was defined as maximum observed serum concentration divided by dose.
Time frame: Day 1: within 2 hours prior to and at the end of the 1-hour infusion, and at 0.5, 1, 2, 4, 6, and 12 hours after the end of the infusion
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs According to National Cancer Institute- Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events that emerge during treatment having been absent pre-treatment, or worsen relative to the pre-treatment state and with onset dates occurring within the first dosing day of study treatment until 30 days after the last dose of study treatment. TEAEs include both Serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.
Time frame: Time from first study treatment up to 139 weeks
Number of Participants With at Least 1 Positive Anti-Avelumab Antibodies (ADA)
Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
Time frame: Time from first study treatment up to 139 weeks
| Milestone | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W | Avelumab 10 mg/kg QW |
|---|---|---|---|---|
| Started | 3 | 7 | 6 | 8 |
| Completed | 3 | 7 | 6 | 8 |
| Not completed | 0 | 0 | 0 | 0 |
DLT is defined as greater than or equal to \[\>=\] Grade (Gr)3 Adverse drug reaction (ADR) according to NCI-CTCAE v4.03, occurring during DLT observation period of dose escalation cohorts. ADR: any AE suspected to be related to avelumab by Investigator and/Sponsor. Following events were not considered as DLT: Gr3 infusion-related reaction resolving within 6 hours and controlled with medical management. Transient (less than or equal to \[\<=\] 6 hours) Gr3 flu-like symptoms/fever, controlled with medical management. Transient (\<=24 hours) Gr3 fatigue, local reactions, headache, nausea, emesis, resolves to \<= Gr1. Gr3 skin toxicity/Gr3 Liver function test increase that resolves to \<= Grade 1 in \< 7 days after medical management. Gr3 diarrhea, out-of-range laboratory values without any clinical correlate that resolves to \<= Grade 1 within 7 days with adequate medical management; Tumor flare phenomenon defined as local pain, irritation, rash localized at sites of known or suspected tumor.
| Participants | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Number of Participants With of Dose-limiting Toxicities (DLTs) According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | 0 | 0 | 0 |
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events that emerge during treatment having been absent pre-treatment, or worsen relative to the pre-treatment state and with onset dates occurring within the first dosing day of study treatment until 30 days after the last dose of study treatment. TEAEs include both Serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.
| Participants | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W | Avelumab 10 mg/kg QW |
|---|---|---|---|---|
| Participants with TEAEs | 3 | 7 | 6 | 8 |
| Participants with Treatment Related TEAEs | 3 | 6 | 6 | 6 |
Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
| Participants | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W | Avelumab 10 mg/kg QW |
|---|---|---|---|---|
| Number of Participants With at Least 1 Positive Anti-Avelumab Antibodies (ADA) | 2 | 0 | 0 | 0 |
Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule.
| microgram*hour per milliliter (mcg*h/mL) | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Area Under the Serum Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Avelumab | 7000 ± 3.0 | 20400 ± 31.3 | 35600 ± 20.6 |
AUCtau was defined as area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
| mcg*h/mL | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Area Under the Serum Concentration-Time Curve During a Dosing Interval (AUCtau) of Avelumab | 7000 ± 2.9 | 20800 ± 27.8 | 35800 ± 22.3 |
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
| mcg*h/mL | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Avelumab | 7710 ± 6.2 | 22600 ± 29.7 | 38300 ± 23.4 |
Lambda z was determined from the terminal slope of the log-transformed serum concentration curve using linear regression method.
| 1/hour | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Terminal Elimination Rate Constant (Lambda z) of Avelumab | 0.00719 ± 18.6 | 0.00767 ± 21.1 | 0.00811 ± 9.1 |
Cmax was obtained directly from the serum concentration versus time curve.
| microgram per milliliter (mcg/mL) | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Avelumab | 77.6 ± 13.9 | 294 ± 44.7 | 450 ± 36.5 |
Clast is the last measurable serum concentration of Avelumab.
| mcg/mL | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Last Quantifiable Serum Concentration (Clast) of Avelumab | 4.94 ± 33.7 | 16.3 ± 51.2 | 21.4 ± 50.3 |
Ctrough is defined as the concentration observed immediately before next dosing.
| mcg/mL | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Serum Trough Concentration Levels (Ctrough) of Avelumab | 4.94 ± 33.7 | 14.8 ± 47.2 | 21.4 ± 50.3 |
The time to reach the maximum observed serum concentration (tmax) was obtained directly from the concentration versus time curve.
| hours | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) of Avelumab | 1.55 (1.53 to 1.62) | 1.52 (1.00 to 6.90) | 1.97 (1.05 to 5.00) |
Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. t1/2 was calculated as log2/ lambda z. Lambda z was determined from the terminal slope of the log-transformed serum concentration curve using linear regression method.
| hours | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Apparent Terminal Half Life (t1/2) of Avelumab | 96.5 ± 18.6 | 90.3 ± 21.1 | 85.5 ± 9.1 |
AUC0-t/Dose was defined as area under the serum concentration versus time curve from time of dosing to the time of the last measurable concentration divided by dose. AUC0-t/Dose was measured in (microgram\*hour per milliliter)/(milligram per kilogram) (mcg\*h/mL)/(mg/kg).
| (mcg*h/mL)/(mg/kg) | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Dose Normalized Area Under the Serum Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of Avelumab | 2330 ± 3.0 | 2040 ± 31.3 | 1780 ± 20.6 |
AUCtau/Dose was calculated by as dose normalized area under the serum concentration-time curve from time zero to the end of the dosing interval (tau). AUCtau was calculated using the mixed log linear trapezoidal rule.
| (mcg*h/mL)/(mg/kg) | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Dose Normalized Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau/Dose) of Avelumab | 2330 ± 2.9 | 2080 ± 27.8 | 1790 ± 22.3 |
Cmax/Dose was defined as maximum observed serum concentration divided by dose.
| (mcg/mL)/(mg/kg) | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W |
|---|---|---|---|
| Dose Normalized Maximum Observed Serum Concentration (Cmax/Dose) of Avelumab | 25.9 ± 13.9 | 29.4 ± 44.7 | 22.5 ± 36.5 |
Collected over Time from first study treatment up to 139 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Avelumab 3 mg/kg Q2W | 1/3 (33.3%) | 1/3 (33.3%) | 3/3 (100%) |
| Avelumab 10 mg/kg Q2W | 4/7 (57.1%) | 3/7 (42.9%) | 7/7 (100%) |
| Avelumab 20 mg/kg Q2W | 6/6 (100%) | 2/6 (33.3%) | 6/6 (100%) |
| Avelumab 10 mg/kg QW | 7/8 (87.5%) | 2/8 (25%) | 8/8 (100%) |
| Event | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W | Avelumab 10 mg/kg QW |
|---|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 1/3 | 0/7 | 0/6 | 0/8 |
| Abdominal painGastrointestinal disorders | 0/3 | 0/7 | 1/6 | 0/8 |
| PneumoniaInfections and infestations | 0/3 | 0/7 | 1/6 | 0/8 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/3 | 0/7 | 1/6 | 0/8 |
| DysphagiaGastrointestinal disorders | 0/3 | 1/7 | 0/6 | 0/8 |
| Head injuryInjury, poisoning and procedural complications | 0/3 | 1/7 | 0/6 | 0/8 |
| HyperuricemiaMetabolism and nutrition disorders | 0/3 | 1/7 | 0/6 | 0/8 |
| ApneaRespiratory, thoracic and mediastinal disorders | 0/3 | 1/7 | 0/6 | 0/8 |
| BronchostenosisRespiratory, thoracic and mediastinal disorders | 0/3 | 1/7 | 0/6 | 0/8 |
| Hepatic failureHepatobiliary disorders | 0/3 | 0/7 | 0/6 | 1/8 |
| Event | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W | Avelumab 10 mg/kg QW |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/3 | 4/7 | 6/6 | 6/8 |
| Weight decreasedInvestigations | 2/3 | 5/7 | 2/6 | 4/8 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/3 | 1/7 | 1/6 | 0/8 |
| NauseaGastrointestinal disorders | 0/3 | 1/7 | 1/6 | 4/8 |
| PyrexiaGeneral disorders | 1/3 | 2/7 | 3/6 | 4/8 |
| Chest painGeneral disorders | 0/3 | 3/7 | 1/6 | 1/8 |
| Blood alkaline phosphatase increasedInvestigations | 0/3 | 3/7 | 0/6 | 1/8 |
| White blood cells urine positiveInvestigations | 0/3 | 3/7 | 0/6 | 0/8 |
| Decreased appetiteMetabolism and nutrition disorders | 1/3 | 3/7 | 2/6 | 3/8 |
| HyperuricaemiaMetabolism and nutrition disorders | 0/3 | 3/7 | 0/6 | 0/8 |
Safety analysis set (SAF) included all participants who have received at least 1 dose of Avelumab.
| Age, Continuous(years) | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W | Avelumab 10 mg/kg QW | Total |
|---|---|---|---|---|---|
| Mean | 54 ± 17.7 | 52 ± 14.3 | 50 ± 16.6 | 61 ± 13.1 | 55 ± 14.7 |
| Sex: Female, Male(Participants) | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W | Avelumab 10 mg/kg QW | Total |
|---|---|---|---|---|---|
| Female | 0 | 2 | 4 | 4 | 10 |
| Male | 3 | 5 | 2 | 4 | 14 |
| Race (NIH/OMB)(Participants) | Avelumab 3 mg/kg Q2W | Avelumab 10 mg/kg Q2W | Avelumab 20 mg/kg Q2W | Avelumab 10 mg/kg QW | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 3 | 7 | 6 | 8 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Avelumab
Merck KGaA, Darmstadt, Germany →