TriangleNCT01772004 · OUTCOME
Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Dose Expansion: Baseline up to Day 2023
What was measured
PD-L1 assessment was performed using immunohistochemistry. PD-L1 expression status was classified as positive or negative based on the following cut-offs: For tumor cells: Participants were considered PD-L1 expression positive (negative): - if at least (less than) 5% of the tumor cells show PD-L1 membrane staining \>= 1+, respectively. This was used as the primary cut-off; - if at least (less than) 25% of the tumor cells show PD-L1 membrane staining \>=2+, respectively. This was considered as secondary cut-off; - if at least (less than) 1% of the tumor cells show PD-L1 membrane staining \>=1+, respectively. This was used as the tertiary cut-off; - if at least (less than) 50% of the tumor cells show PD-L1 membrane staining \>=1+, respectively. This was used as the '50% cut-off'; - if at least (less than) 80% of the tumor cells show PD-L1 membrane staining ≥1+, respectively. This was used as the '80% cut-off'.
Analysis population: Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.
Groups in this outcome
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Adrenocortical Carcinoma
Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Melanoma
Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: GC/GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 184 |
| Primary Expansion Cohort: NSCLC, First Line | 156 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 168 |
| Primary Expansion Cohort: GC/GEJC Progressed | 60 |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 90 |
| Secondary Expansion Cohort: Colorectal Cancer | 21 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 18 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 50 |
| Secondary Expansion Cohort: Melanoma | 51 |
| Secondary Expansion Cohort: Mesothelioma | 53 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 44 |
| Secondary Expansion Cohort: Ovarian Cancer | 125 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 62 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 20 |
| Efficacy Expansion Cohort: Ovarian Cancer | 103 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 205 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 132 |
| Efficacy Expansion Cohort: HNSCC | 153 |
Reported measurements
PD-L1 expression status - 1% cutoff
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 184 |
| Primary Expansion Cohort: NSCLC, First Line | 156 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 168 |
| Primary Expansion Cohort: GC/GEJC Progressed | 60 |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 90 |
| Secondary Expansion Cohort: Colorectal Cancer | 21 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 18 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 50 |
| Secondary Expansion Cohort: Melanoma | 51 |
| Secondary Expansion Cohort: Mesothelioma | 53 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 44 |
| Secondary Expansion Cohort: Ovarian Cancer | 125 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 62 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 20 |
| Efficacy Expansion Cohort: Ovarian Cancer | 103 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 205 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 132 |
| Efficacy Expansion Cohort: HNSCC | 153 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 122 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 88 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 87 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Progressed | 20 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 26 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 5 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 15 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 19 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 22 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 14 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 76 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 20 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 4 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 45 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 87 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 39 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 107 | Not reported | Not reported | Not reported | Not reported |
PD-L1 expression status - 5% cutoff
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 184 |
| Primary Expansion Cohort: NSCLC, First Line | 156 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 168 |
| Primary Expansion Cohort: GC/GEJC Progressed | 0 |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 0 |
| Secondary Expansion Cohort: Colorectal Cancer | 21 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 18 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 50 |
| Secondary Expansion Cohort: Melanoma | 51 |
| Secondary Expansion Cohort: Mesothelioma | 53 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 44 |
| Secondary Expansion Cohort: Ovarian Cancer | 125 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 62 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 20 |
| Efficacy Expansion Cohort: Ovarian Cancer | 103 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 205 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 132 |
| Efficacy Expansion Cohort: HNSCC | 153 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 84 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 76 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 25 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 12 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 15 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 16 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 13 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 32 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 11 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 1 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 23 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 72 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 16 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 93 | Not reported | Not reported | Not reported | Not reported |
PD-L1 expression status - 25% cutoff
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 184 |
| Primary Expansion Cohort: NSCLC, First Line | 156 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 168 |
| Primary Expansion Cohort: GC/GEJC Progressed | 0 |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 0 |
| Secondary Expansion Cohort: Colorectal Cancer | 21 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 18 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 50 |
| Secondary Expansion Cohort: Melanoma | 51 |
| Secondary Expansion Cohort: Mesothelioma | 53 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 44 |
| Secondary Expansion Cohort: Ovarian Cancer | 125 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 62 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 20 |
| Efficacy Expansion Cohort: Ovarian Cancer | 103 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 205 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 132 |
| Efficacy Expansion Cohort: HNSCC | 153 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 53 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 50 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 3 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 3 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 7 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 8 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 5 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 3 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 2 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 0 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 6 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 25 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 6 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 48 | Not reported | Not reported | Not reported | Not reported |
PD-L1 expression status - 50% cutoff
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 184 |
| Primary Expansion Cohort: NSCLC, First Line | 156 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 168 |
| Primary Expansion Cohort: GC/GEJC Progressed | 0 |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 0 |
| Secondary Expansion Cohort: Colorectal Cancer | 21 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 18 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 50 |
| Secondary Expansion Cohort: Melanoma | 51 |
| Secondary Expansion Cohort: Mesothelioma | 53 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 44 |
| Secondary Expansion Cohort: Ovarian Cancer | 125 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 62 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 20 |
| Efficacy Expansion Cohort: Ovarian Cancer | 103 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 205 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 0 |
| Efficacy Expansion Cohort: HNSCC | 153 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 54 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 53 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 13 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 5 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 8 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 5 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 5 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 2 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 1 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 0 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 4 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 34 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 51 | Not reported | Not reported | Not reported | Not reported |
PD-L1 expression status - 80% cutoff
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 184 |
| Primary Expansion Cohort: NSCLC, First Line | 156 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 0 |
| Primary Expansion Cohort: GC/GEJC Progressed | 0 |
| Primary Expansion Cohort: GC/GEJC Non Progressed | 0 |
| Secondary Expansion Cohort: Colorectal Cancer | 0 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 18 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 50 |
| Secondary Expansion Cohort: Melanoma | 51 |
| Secondary Expansion Cohort: Mesothelioma | 53 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 44 |
| Secondary Expansion Cohort: Ovarian Cancer | 125 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 62 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 20 |
| Efficacy Expansion Cohort: Ovarian Cancer | 103 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 205 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 0 |
| Efficacy Expansion Cohort: HNSCC | 153 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 41 | Not reported | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 38 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 2 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 2 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 2 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 3 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 2 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 0 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 0 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 25 | Not reported | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 28 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 88
- group Id
- OG002
- value
- 87
- group Id
- OG003
- value
- 20
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 19
- group Id
- OG009
- value
- 22
- group Id
- OG010
- value
- 14
- group Id
- OG011
- value
- 76
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 168
- group Id
- OG003
- value
- 60
- group Id
- OG004
- value
- 90
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 51
- group Id
- OG009
- value
- 53
- group Id
- OG010
- value
- 44
- group Id
- OG011
- value
- 125
- units
- Participants
- title
- PD-L1 expression status - 1% cutoff
- categories
- measurements
- group Id
- OG000
- value
- 84
- group Id
- OG001
- value
- 76
- group Id
- OG002
- value
- 25
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 15
- group Id
- OG009
- value
- 16
- group Id
- OG010
- value
- 13
- group Id
- OG011
- value
- 32
- group Id
- OG012
- value
- 11
- group Id
- OG013
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 168
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 51
- group Id
- OG009
- value
- 53
- group Id
- OG010
- value
- 44
- group Id
- OG011
- value
- 125
- units
- Participants
- title
- PD-L1 expression status - 5% cutoff
- categories
- measurements
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 3
- group Id
- OG012
- value
- 2
- group Id
- OG013
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 168
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 51
- group Id
- OG009
- value
- 53
- group Id
- OG010
- value
- 44
- group Id
- OG011
- value
- 125
- units
- Participants
- title
- PD-L1 expression status - 25% cutoff
- categories
- measurements
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 53
- group Id
- OG002
- value
- 13
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 2
- group Id
- OG012
- value
- 1
- group Id
- OG013
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 168
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 51
- group Id
- OG009
- value
- 53
- group Id
- OG010
- value
- 44
- group Id
- OG011
- value
- 125
- units
- Participants
- title
- PD-L1 expression status - 50% cutoff
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 38
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 2
- group Id
- OG012
- value
- 0
- group Id
- OG013
- value
- 0
- group Id
- OG014
- value
- 0
- group Id
- OG015
- value
- 25
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 51
- group Id
- OG009
- value
- 53
- group Id
- OG010
- value
- 44
- group Id
- OG011
- value
- 125
- units
- Participants
- title
- PD-L1 expression status - 80% cutoff
- denoms
- counts
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 168
- group Id
- OG003
- value
- 60
- group Id
- OG004
- value
- 90
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 51
- group Id
- OG009
- value
- 53
- group Id
- OG010
- value
- 44
- group Id
- OG011
- value
- 125
- units
- Participants
- description
- PD-L1 assessment was performed using immunohistochemistry. PD-L1 expression status was classified as positive or negative based on the following cut-offs: For tumor cells: Participants were considered PD-L1 expression positive (negative): - if at least (less than) 5% of the tumor cells show PD-L1 membrane staining \>= 1+, respectively. This was used as the primary cut-off; - if at least (less than) 25% of the tumor cells show PD-L1 membrane staining \>=2+, respectively. This was considered as secondary cut-off; - if at least (less than) 1% of the tumor cells show PD-L1 membrane staining \>=1+, respectively. This was used as the tertiary cut-off; - if at least (less than) 50% of the tumor cells show PD-L1 membrane staining \>=1+, respectively. This was used as the '50% cut-off'; - if at least (less than) 80% of the tumor cells show PD-L1 membrane staining ≥1+, respectively. This was used as the '80% cut-off'.
- groups
- description
- Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG000
- title
- Primary Expansion Cohort: NSCLC, Post-platinum Doublet
- description
- Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG001
- title
- Primary Expansion Cohort: NSCLC, First Line
- description
- Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG002
- title
- Primary Expansion Cohort: Metastatic Breast Cancer
- description
- Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG003
- title
- Primary Expansion Cohort: GC/GEJC Progressed
- description
- Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG004
- title
- Primary Expansion Cohort: GC/GEJC Non Progressed
- description
- Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG005
- title
- Secondary Expansion Cohort: Colorectal Cancer
- description
- Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG006
- title
- Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
- description
- Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG007
- title
- Secondary Expansion Cohort: Adrenocortical Carcinoma
- description
- Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG008
- title
- Secondary Expansion Cohort: Melanoma
- description
- Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG009
- title
- Secondary Expansion Cohort: Mesothelioma
- description
- Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG010
- title
- Secondary Expansion Cohort: Urothelial Carcinoma
- description
- Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- OG011
- title
- Secondary Expansion Cohort: Ovarian Cancer
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.
- reporting Status
- POSTED
- time Frame
- Dose Expansion: Baseline up to Day 2023
- title
- Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice