A Phase 2 interventional study of Avelumab (MSB0010718C) and Axitinib (AG-013736) in Non-Small Cell Lung Cancer and Urothelial Cancer, sponsored by Pfizer. Terminated at 39 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 15 studies testing avelumab in Carcinoma, Non-Small-Cell Lung — 1 open to participants now, 2 under way, 1 of them phase 3. avelumab · Carcinoma, Non-Small-Cell Lung.
Among the 15 studies testing avelumab in Carcinoma, Non-Small-Cell Lung, this one is the 9th largest by enrollment, is one of 4 that started in 2018, is one of 3 in phase 2, and was the 11th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →1 of the 15 studies testing avelumab in Carcinoma, Non-Small-Cell Lung is open now, in 1 country. Recruiting first, the newest first:
Institut Bergonié · Sites in France
Ages 18+
By country, each count listing its studies:
avelumab: first FDA approval 2017 (BAVENCIO), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 8 · Phase 3 3
First in 2013; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 61 is close to the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 67 across the 15 interventional studies. Of the 12 that completed or were terminated, 10 (83%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 15 have an industry lead sponsor. The 9 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
158 studies in Carcinoma, Non-Small-Cell Lung by Pfizer: 15 open now, 26 under way, 5 of them phase 3. Of 123 finished, 70 (57%) have results posted.
Among the 158 studies in Carcinoma, Non-Small-Cell Lung by Pfizer, this one is the 79th largest by enrollment of the 136 interventional ones that give a count, is one of 3 that started in 2018, is one of 45 in phase 2, and was the 83rd registered.
Pfizer’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 1999.
1 of the studies testing avelumab in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
Add it to your calendar (.ics) → With an account.
Among the 15 studies testing avelumab in Carcinoma, Non-Small-Cell Lung, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Pfizer’s 158 in Carcinoma, Non-Small-Cell Lung:
This tab as a report to print or save as PDF → With an account.
This is a Phase 2 study to evaluate the safety and efficacy of avelumab in combination with axitinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior platinum containing therapy, and in treatment naïve patients with advanced or metastatic urothelial cancer, who are ineligible for cisplatin containing chemotherapy for their advanced disease.
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.
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 line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
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.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
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.
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.
Avelumab administered at 800 mg IV every two weeks in combination with axitinib, 5 mg PO BID.
Drug: Avelumab (MSB0010718C) · Drug: Axitinib (AG-013736)
IV treatment: Avelumab administered at 800 mg IV every two weeks
Also known as: Bavencio
Oral treatment: Axitinib given 5 mg PO BID
Also known as: Inlyta
Percentage of Participants With Confirmed Objective Response- Objective Response Rate (ORR)
ORR: percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) based on investigator's assessment as per Response Evaluation Criteria in Solid Tumours (RECIST version \[v\] 1.1). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after criteria for response was first met. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\]10 millimeter \[mm\]). No new lesions. PR was defined as greater than or equal to (\>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, Progressive Disease.
Time frame: Baseline up to 56 months
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During the On-Treatment Period
An Adverse Event (AE) was any untoward medical occurrence attributed to study drug in a participant who received avelumab or axitinib. Treatment-emergent adverse events (TEAEs) were those events with onset dates occurring during the on-treatment period (the time from the first dose of study treatment through minimum 30 days post last dose of study treatment or start day of new anti-cancer treatment -1 day).
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer treatment -1 day (maximum up to 56 months)
Percentage of Participants With Hematology Test Results of Maximum National Cancer Institute; Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade During the On-Treatment Period
The following hematology parameters were assessed: anemia, hemoglobin increased, international normalized ratio (INR) increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 3= severe and grade 4= life-threatening). Categories with non-zero values are presented.
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer treatment -1 day (maximum up to 56 months)
Percentage of Participants With Chemistry Test Results of Maximum CTCAE Grade During the On-Treatment Period
The following chemistry parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatine phosphokinase (CPK) increased, creatinine increased, gamma-glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase increased and serum amylase increased. Laboratory abnormalities were graded according CTCAE version 4.03 (grade 3= severe, grade 4= life-threatening and grade 5= death related). Categories with non-zero values are presented.
Time frame: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer treatment -1 day (maximum up to 56 months)
Time to Tumor Response (TTR) in Participants With Confirmed CR or PR
TTR was defined as the time from the first dose of study treatment to the first documentation of objective tumor response documented in participants with confirmed objective response (CR or PR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Analysis was performed using Kaplan-Meier method.
Time frame: From date of start of treatment until date of first documentation of objective tumor response (maximum up to 56 months)
Duration of Response in Participants With Confirmed CR or PR
Duration of response was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first in participants with confirmed objective response (CR or PR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Analysis was performed using Kaplan-Meier method.
Time frame: From date of first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 56 months)
Progression Free Survival (PFS)
PFS was defined as the time from first dose of study treatment (ie, start date) to the date of progression of disease (PD) by RECIST v 1.1 or death due to any cause, whichever occurred first. PFS data was censored on the date of the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to an event, or for participants with an event after two or more missing tumor assessments. PD as per RECIST v1.1 for target lesions was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. For non-target lesions PD was defined as unequivocal progression of pre-existing lesions. Analysis was performed using Kaplan-Meier method.
Time frame: From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 24 months)
Overall Survival
Overall survival was defined as the time from the date of first study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 56 months)
Maximum Observed Serum Concentration (Cmax) of Avelumab
Time frame: Pre-dose, 1 hour post-dose on Cycle 1 Day 1, Day 15 and Cycle 2 Day 1
Cmax of Axitinib
Time frame: Pre-dose, 2 hour post-dose on Cycle 1 Day 15, Cycle 2 Day 1 and 15
Pre-dose Observed Serum Concentration (Ctrough) of Avelumab
Time frame: Pre-dose on Cycle 1 Day 1, 15, Cycle 2 Day 1, Cycle 3 Day 15, Cycle 6 Day 15, Cycle 9 Day 15, and Cycle 12 Day 15
Ctrough of Axitinib
Time frame: Pre-dose on Cycle 1 Day 15, Cycle 2 Day 1 and 15
Number of Participants With Programmed Death-Ligand 1 (PD-L1) Status
PD-L1 status was defined as positive when PD-L1 staining of any intensity was observed in \>= 1% of the tumor cells. PD-L1 status was defined as negative when PD-L1 staining of any intensity was observed in \< 1% of the tumor cells.
Time frame: Screening, up to 28 days prior to Day 1
Tumour Mutational Burden (TMB) in Tumor Tissue
Mutational load within tumor tissue was defined as number per megabase of the genome, coding, base substitution, and indel mutations present in the sample. Mutational load was determined in whole blood samples using next generation deoxyribonucleic acid (DNA) sequencing followed by computational analysis.
Time frame: Screening, up to 28 days prior to Day 1
T-cell Receptor (TCR) Sequencing to Identify Fraction Productive of Cells
The immune response was measured by total T cell receptor (TCR) sequencing in peripheral blood and determined the characterization of immune repertoires. Fraction productive of cells is defined as the number of T cells within the total nucleated cell count (T cells and non-T cells).
Time frame: Screening, up to 28 days prior to Day 1
T-cell Receptor (TCR) Sequencing to Identify Simpson Clonality
The immune response was measured by TCR sequencing in peripheral blood and determined the characterization of immune repertoires. Simpson clonality is calculated for a sample as the square root of Simpson's diversity index for all productive rearrangements. Values for clonality ranged from 0 to 1. Values near 1 represented samples with one or a few predominant rearrangements (monoclonal or oligoclonal samples) dominating the observed repertoire. Clonality values near 0 represented more polyclonal samples.
Time frame: Pre-dose on Day 1 of Cycle 1
T-cell Receptor (TCR) Sequencing to Identify Total T Cells
The immune response was measured by total TCR sequencing in peripheral blood and determined the characterization of immune repertoires.
Time frame: Pre-dose on Day 1 of Cycle 1
Number of Participants With Positive Anti-drug Antibody (ADA) and Neutralizing Antibodies (nAb) Against Avelumab
ADA and nAb positive was defined as presence of at least one positive ADA and nAb sample, respectively. NAb analysis was planned to be conducted for ADA positive samples.
Time frame: Within 2 hours pre-dose on Cycle 1 Day 1,15, Cycle 2 Day 1; Day 15 of Cycle 3, 6, 9, 12, end of treatment and 30 days after last dose of study treatment (maximum up to 56 months)
Participants diagnosed with advanced or metastatic non- small cell lung cancer (NSCLC) and received at least 1 prior platinum-containing therapy or participants with advanced or metastatic urothelial cancer (UC) and were treatment naïve and ineligible for cisplatin-containing chemotherapy for their advanced disease were enrolled.
| Milestone | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Started | 41 | 20 |
| Completed | 0 | 0 |
| Not completed | 41 | 20 |
| Withdrew: Subject transfer to continuation protocol | 0 | 1 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Progressive disease | 24 | 8 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Death | 7 | 4 |
| Withdrew: Adverse event | 5 | 3 |
| Withdrew: Global deterioration of health status | 0 | 4 |
ORR: percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) based on investigator's assessment as per Response Evaluation Criteria in Solid Tumours (RECIST version \[v\] 1.1). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after criteria for response was first met. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\]10 millimeter \[mm\]). No new lesions. PR was defined as greater than or equal to (\>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, Progressive Disease.
| Percentage of participants | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Percentage of Participants With Confirmed Objective Response- Objective Response Rate (ORR) | 31.7 (18.1 to 48.1) | 10.0 (1.2 to 31.7) |
An Adverse Event (AE) was any untoward medical occurrence attributed to study drug in a participant who received avelumab or axitinib. Treatment-emergent adverse events (TEAEs) were those events with onset dates occurring during the on-treatment period (the time from the first dose of study treatment through minimum 30 days post last dose of study treatment or start day of new anti-cancer treatment -1 day).
| Percentage of Participants | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During the On-Treatment Period | 100.0 | 100.0 |
The following hematology parameters were assessed: anemia, hemoglobin increased, international normalized ratio (INR) increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 3= severe and grade 4= life-threatening). Categories with non-zero values are presented.
| Percentage of participants | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Lymphocyte count decreased (Grade >=3) | 12.2 | 5.6 |
| Neutrophil count decreased (Grade >=3) | 2.4 | 0 |
| Platelet count decreased (Grade >=3) | 0 | 5.6 |
| White blood cell decreased (Grade >=3) | 2.4 | 0 |
The following chemistry parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatine phosphokinase (CPK) increased, creatinine increased, gamma-glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase increased and serum amylase increased. Laboratory abnormalities were graded according CTCAE version 4.03 (grade 3= severe, grade 4= life-threatening and grade 5= death related). Categories with non-zero values are presented.
| Percentage of participants | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Alanine aminotransferase increased (Grade 3) | 7.3 | 5.6 |
| Alkaline phosphatase increased (Grade 3) | 2.4 | 11.1 |
| Aspartate aminotransferase increased (Grade 3) | 2.4 | 5.6 |
| Blood bilirubin increased (Grade 3) | 2.4 | 0 |
| Creatinine increased (Grade 3) | 2.4 | 5.6 |
| GGT increased (Grade 3) | 7.5 | 18.8 |
| Hyperglycemia (Grade 3) | 4.9 | 5.6 |
| Hyperglycemia (Grade 4) | 2.4 | 0 |
| Hyperkalemia (Grade 3) | 7.3 | 0 |
| Hypermagnesemia (Grade 3) | 2.4 | 0 |
| Hypermagnesemia (Grade 4) | 0 | 5.6 |
| Hypoalbuminemia (Grade 3) | 0 | 5.6 |
| Hypocalcemia (Grade 3) | 4.9 | 5.6 |
| Hypoglycemia (Grade 4) | 2.4 | 0 |
| Hypokalemia (Grade 3) | 4.9 | 0 |
| Hypomagnesemia (Grade 3) | 2.4 | 0 |
| Hypomagnesemia (Grade 4) | 2.4 | 0 |
| Hyponatremia (Grade 3) | 9.8 | 16.7 |
| Hyponatremia (Grade 4) | 2.4 | 0 |
| Hypophosphatemia (Grade 3) | 4.9 | 5.6 |
| Lipase increased (Grade 3) | 10.3 | 6.3 |
| Lipase increased (Grade 4) | 2.6 | 6.3 |
| Serum amylase increase (Grade 3) | 2.5 | 12.5 |
TTR was defined as the time from the first dose of study treatment to the first documentation of objective tumor response documented in participants with confirmed objective response (CR or PR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Analysis was performed using Kaplan-Meier method.
| Months | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Time to Tumor Response (TTR) in Participants With Confirmed CR or PR | 1.9 (1.8 to 5.3) | 2.8 (1.8 to 3.7) |
Duration of response was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first in participants with confirmed objective response (CR or PR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Analysis was performed using Kaplan-Meier method.
| Months | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Duration of Response in Participants With Confirmed CR or PR | 7.5 (3.7 to 15.5) | 17.4 (5.6 to 29.2) |
PFS was defined as the time from first dose of study treatment (ie, start date) to the date of progression of disease (PD) by RECIST v 1.1 or death due to any cause, whichever occurred first. PFS data was censored on the date of the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to an event, or for participants with an event after two or more missing tumor assessments. PD as per RECIST v1.1 for target lesions was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. For non-target lesions PD was defined as unequivocal progression of pre-existing lesions. Analysis was performed using Kaplan-Meier method.
| Months | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Progression Free Survival (PFS) | 5.5 (2.5 to 7.0) | 2.3 (1.8 to 5.6) |
Overall survival was defined as the time from the date of first study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
| Months | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Overall Survival | 15.4 (8.0 to 26.9) | 16.8 (2.3 to 35.4) |
| Microgram per milliliter | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Cycle 1 (Day 1) | 235.0 ± 26 | 206.3 ± 27 |
| Cycle 1 (Day 15) | 264.0 ± 34 | 163.9 ± 211 |
| Cycle 2 (Day 1) | 283.2 ± 24 | 260.4 ± 25 |
| Microgram per milliliter | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Cycle 1 (Day 15) | 17.29 ± 198 | 14.64 ± 448 |
| Cycle 2 (Day 1) | 16.46 ± 91 | 5.206 ± 448 |
| Cycle 2 (Day15) | 10.64 ± 223 | 2.868 ± 24 |
| Microgram per milliliter | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Cycle 1 (Day 1) | 0 ± 0 | 0 ± 0 |
| Cycle 1 (Day 15) | 19.46 ± 80 | 18.84 ± 101 |
| Cycle 2 (Day 1) | 20.96 ± 119 | 19.62 ± 91 |
| Cycle 3 (Day 15) | 28.22 ± 55 | 39.29 ± 36 |
| Cycle 6 (Day 15) | 29.68 ± 52 | 43.30 ± 57 |
| Cycle 9 (Day 15) | 32.84 ± 29 | 42.41 ± 47 |
| Cycle 12 (Day 15) | 36.71 ± 50 | 39.01 ± 20 |
| Microgram per milliliter | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Cycle 1 (Day 15) | 7.923 ± 127 | 4.613 ± 231 |
| Cycle 2 (Day 1) | 8.871 ± 123 | 5.247 ± 172 |
| Cycle 2 (Day 15) | 6.455 ± 129 | 3.944 ± 172 |
PD-L1 status was defined as positive when PD-L1 staining of any intensity was observed in \>= 1% of the tumor cells. PD-L1 status was defined as negative when PD-L1 staining of any intensity was observed in \< 1% of the tumor cells.
| Participants | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| PD-L1 positive | 8 | 5 |
| PD-L1 negative | 24 | 11 |
Mutational load within tumor tissue was defined as number per megabase of the genome, coding, base substitution, and indel mutations present in the sample. Mutational load was determined in whole blood samples using next generation deoxyribonucleic acid (DNA) sequencing followed by computational analysis.
| Mutations per megabase | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Tumour Mutational Burden (TMB) in Tumor Tissue | 2.8 ± 2.97 | 3.7 ± 4.53 |
The immune response was measured by total T cell receptor (TCR) sequencing in peripheral blood and determined the characterization of immune repertoires. Fraction productive of cells is defined as the number of T cells within the total nucleated cell count (T cells and non-T cells).
| Proportion of T cells | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| T-cell Receptor (TCR) Sequencing to Identify Fraction Productive of Cells | 0.2 ± 0.17 | 0.1 ± 0.08 |
The immune response was measured by TCR sequencing in peripheral blood and determined the characterization of immune repertoires. Simpson clonality is calculated for a sample as the square root of Simpson's diversity index for all productive rearrangements. Values for clonality ranged from 0 to 1. Values near 1 represented samples with one or a few predominant rearrangements (monoclonal or oligoclonal samples) dominating the observed repertoire. Clonality values near 0 represented more polyclonal samples.
| Index | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| T-cell Receptor (TCR) Sequencing to Identify Simpson Clonality | 0.1 ± 0.04 | 0.1 ± 0.03 |
The immune response was measured by total TCR sequencing in peripheral blood and determined the characterization of immune repertoires.
| Cells | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| T-cell Receptor (TCR) Sequencing to Identify Total T Cells | 1623.7 ± 1971.39 | 1168.4 ± 1450.51 |
ADA and nAb positive was defined as presence of at least one positive ADA and nAb sample, respectively. NAb analysis was planned to be conducted for ADA positive samples.
| Participants | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| ADA ever-Positive | 7 | 0 |
Collected over From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer treatment -1 day (maximum up to 56 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NSCLC Avelumab + Axitinib | 27/41 (65.9%) | 21/41 (51.2%) | 41/41 (100%) |
| UC Avelumab + Axitinib | 11/20 (55%) | 11/20 (55%) | 17/20 (85%) |
| Event | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| Disease progressionGeneral disorders | 4/41 | 3/20 |
| HaematuriaRenal and urinary disorders | 0/41 | 2/20 |
| PyrexiaGeneral disorders | 3/41 | 0/20 |
| FatigueGeneral disorders | 0/41 | 1/20 |
| ColitisGastrointestinal disorders | 0/41 | 1/20 |
| DysphagiaGastrointestinal disorders | 0/41 | 1/20 |
| COVID-19 pneumoniaInfections and infestations | 0/41 | 1/20 |
| Kidney infectionInfections and infestations | 0/41 | 1/20 |
| SepsisInfections and infestations | 2/41 | 1/20 |
| Urinary tract infectionInfections and infestations | 0/41 | 1/20 |
| Event | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib |
|---|---|---|
| HypertensionVascular disorders | 17/41 | 4/20 |
| Decreased appetiteMetabolism and nutrition disorders | 14/41 | 5/20 |
| HypothyroidismEndocrine disorders | 13/41 | 1/20 |
| Weight decreasedInvestigations | 9/41 | 6/20 |
| DiarrhoeaGastrointestinal disorders | 12/41 | 3/20 |
| AstheniaGeneral disorders | 7/41 | 5/20 |
| FatigueGeneral disorders | 9/41 | 5/20 |
| Alanine aminotransferase increasedInvestigations | 9/41 | 3/20 |
| NauseaGastrointestinal disorders | 8/41 | 4/20 |
| Aspartate aminotransferase increasedInvestigations | 8/41 | 4/20 |
Full Analysis Set included all participants who received at least one dose of avelumab and axitinib.
| Age, Continuous(Years) | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib | Total |
|---|---|---|---|
| Mean | 64.0 ± 8.93 | 70.7 ± 8.66 | 66.16 ± 9.33 |
| Sex: Female, Male(Participants) | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib | Total |
|---|---|---|---|
| Female | 11 | 8 | 19 |
| Male | 30 | 12 | 42 |
| Ethnicity (NIH/OMB)(Participants) | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 40 | 17 | 57 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | NSCLC Avelumab + Axitinib | UC Avelumab + Axitinib | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 21 | 1 | 22 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 20 | 17 | 37 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from May 2018 to primary completion in Feb 2023, 57 months.
Results were first posted in Apr 2024, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Avelumab · Axitinib
Carcinoma, Non-Small-Cell Lung →