TriangleNCT01772004 · OUTCOME
Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Microgram per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- At Day 15, 29, 43, 57, 71, 85, 99, 127 and 169
What was measured
Serum Ctrough concentration of Avelumab is reported.
Analysis population: Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data for "primary expansion cohort: GC/GEJC Progressed" and "primary expansion cohort: GC/GEJC Non progressed" arms was reported as a single arm "primary expansion cohort: GC/GEJC Progressed/Non progressed" for this outcome measure as per planned analysis.
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: GC/GEJC (Progressed/Non Progressed)
Participants with gastric and gastroesophageal cancer who progressed/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.
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.
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: 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: 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: 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.
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.
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.
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.
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 163 |
| Primary Expansion Cohort: NSCLC, First Line | 124 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 129 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 154 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 32 |
| Secondary Expansion Cohort: Colorectal Cancer | 17 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 13 |
| Secondary Expansion Cohort: Melanoma | 45 |
| Secondary Expansion Cohort: Mesothelioma | 48 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 57 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 17 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 43 |
| Secondary Expansion Cohort: Ovarian Cancer | 118 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 21 |
| Efficacy Expansion Cohort: HNSCC | 117 |
| Efficacy Expansion Cohort: Ovarian Cancer | 87 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 82 |
Reported measurements
Day 15
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 163 |
| Primary Expansion Cohort: NSCLC, First Line | 124 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 129 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 154 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 32 |
| Secondary Expansion Cohort: Colorectal Cancer | 17 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 12 |
| Secondary Expansion Cohort: Melanoma | 45 |
| Secondary Expansion Cohort: Mesothelioma | 48 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 57 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 16 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 43 |
| Secondary Expansion Cohort: Ovarian Cancer | 118 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 21 |
| Efficacy Expansion Cohort: HNSCC | 117 |
| Efficacy Expansion Cohort: Ovarian Cancer | 87 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 82 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 20.4 | 16.1 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 18.3 | 10.3 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 22.5 | 11.1 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 23.7 | 24.6 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 17.8 | 9.51 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 22.4 | 14.1 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 28.8 | 14.5 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 22.3 | 13.4 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 21.7 | 26.7 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 26.9 | 14.4 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 25.1 | 11.6 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 21.3 | 12.0 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 23.1 | 14.1 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 18.1 | 12.4 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 20.1 | 10.1 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 22.3 | 11.1 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 17.6 | 10.7 | Not reported | Not reported | Not reported |
Day 29
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 149 |
| Primary Expansion Cohort: NSCLC, First Line | 109 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 117 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 142 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 28 |
| Secondary Expansion Cohort: Colorectal Cancer | 17 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 13 |
| Secondary Expansion Cohort: Melanoma | 41 |
| Secondary Expansion Cohort: Mesothelioma | 45 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 50 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 15 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 38 |
| Secondary Expansion Cohort: Ovarian Cancer | 109 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 20 |
| Efficacy Expansion Cohort: HNSCC | 104 |
| Efficacy Expansion Cohort: Ovarian Cancer | 85 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 74 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 23.5 | 15.4 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 23.5 | 15.1 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 25.6 | 15.2 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 26.5 | 17.0 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 17.3 | 13.6 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 25.5 | 20.1 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 31.6 | 15.9 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 23.8 | 17.3 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 20.7 | 12.4 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 35.7 | 22.3 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 27.4 | 16.6 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 26.2 | 16.9 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 27.7 | 18.3 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 18.6 | 16.0 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 27.0 | 23.9 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 23.9 | 16.2 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 21.3 | 13.0 | Not reported | Not reported | Not reported |
Day 43
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 126 |
| Primary Expansion Cohort: NSCLC, First Line | 96 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 94 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 96 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 21 |
| Secondary Expansion Cohort: Colorectal Cancer | 11 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 8 |
| Secondary Expansion Cohort: Melanoma | 34 |
| Secondary Expansion Cohort: Mesothelioma | 37 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 51 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 17 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 33 |
| Secondary Expansion Cohort: Ovarian Cancer | 93 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 14 |
| Efficacy Expansion Cohort: HNSCC | 80 |
| Efficacy Expansion Cohort: Ovarian Cancer | 62 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 60 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 24.6 | 15.6 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 23.8 | 15.9 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 28.3 | 18.2 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 29.7 | 17.8 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 20.6 | 14.3 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 23.2 | 24.2 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 32.3 | 16.3 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 29.3 | 22.9 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 23.6 | 18.9 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 35.7 | 22.6 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 29.4 | 19.7 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 28.1 | 18.9 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 28.4 | 20.9 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 19.8 | 21.5 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 29.0 | 17.6 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 27.7 | 18.1 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 25.2 | 17.7 | Not reported | Not reported | Not reported |
Day 57
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 104 |
| Primary Expansion Cohort: NSCLC, First Line | 86 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 86 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 78 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 15 |
| Secondary Expansion Cohort: Colorectal Cancer | 0 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 |
| Secondary Expansion Cohort: Melanoma | 26 |
| Secondary Expansion Cohort: Mesothelioma | 36 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 46 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 15 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 30 |
| Secondary Expansion Cohort: Ovarian Cancer | 80 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 11 |
| Efficacy Expansion Cohort: HNSCC | 55 |
| Efficacy Expansion Cohort: Ovarian Cancer | 48 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 57 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 26.2 | 17.3 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 23.4 | 16.1 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 26.5 | 14.1 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 28.9 | 14.5 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 22.2 | 19.8 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 29.9 | 22.4 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 18.2 | 11.7 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 39.8 | 25.5 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 25.5 | 18.7 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 29.7 | 22.8 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 27.3 | 21.5 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 16.2 | 15.2 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 30.6 | 18.1 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 28.5 | 20.3 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 24.1 | 15.6 | Not reported | Not reported | Not reported |
Day 71
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 101 |
| Primary Expansion Cohort: NSCLC, First Line | 73 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 83 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 70 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 15 |
| Secondary Expansion Cohort: Colorectal Cancer | 0 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 |
| Secondary Expansion Cohort: Melanoma | 27 |
| Secondary Expansion Cohort: Mesothelioma | 33 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 46 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 13 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 24 |
| Secondary Expansion Cohort: Ovarian Cancer | 74 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 8 |
| Efficacy Expansion Cohort: HNSCC | 48 |
| Efficacy Expansion Cohort: Ovarian Cancer | 36 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 47 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 27.9 | 36.5 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 31.0 | 40.1 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 28.1 | 16.6 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 29.9 | 15.4 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 22.0 | 15.5 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 28.8 | 23.6 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 21.0 | 14.2 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 38.4 | 33.4 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 27.8 | 17.6 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 29.4 | 22.1 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 33.4 | 31.8 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 19.6 | 15.3 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 31.1 | 18.8 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 30.4 | 23.0 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 24.2 | 14.7 | Not reported | Not reported | Not reported |
Day 85
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 81 |
| Primary Expansion Cohort: NSCLC, First Line | 60 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 67 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 43 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 10 |
| Secondary Expansion Cohort: Colorectal Cancer | 4 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 6 |
| Secondary Expansion Cohort: Melanoma | 22 |
| Secondary Expansion Cohort: Mesothelioma | 24 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 43 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 11 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 23 |
| Secondary Expansion Cohort: Ovarian Cancer | 47 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 2 |
| Efficacy Expansion Cohort: HNSCC | 31 |
| Efficacy Expansion Cohort: Ovarian Cancer | 24 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 41 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 27.8 | 18.9 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 27.7 | 16.7 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 29.7 | 18.1 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 28.9 | 16.8 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 24.9 | 29.0 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 8.03 | 0.988 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 37.9 | 18.3 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 35.6 | 23.7 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 23.7 | 15.8 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 39.7 | 27.2 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 34.4 | 20.2 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 34.7 | 20.5 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 39.1 | 28.3 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 19.3 | 3.60 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 35.6 | 20.7 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 31.2 | 22.0 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 28.0 | 14.6 | Not reported | Not reported | Not reported |
Day 99
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 0 |
| Primary Expansion Cohort: NSCLC, First Line | 32 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 0 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 0 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 0 |
| Secondary Expansion Cohort: Colorectal Cancer | 0 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 |
| Secondary Expansion Cohort: Melanoma | 0 |
| Secondary Expansion Cohort: Mesothelioma | 0 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 0 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 0 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 0 |
| Secondary Expansion Cohort: Ovarian Cancer | 0 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 0 |
| Efficacy Expansion Cohort: HNSCC | 0 |
| Efficacy Expansion Cohort: Ovarian Cancer | 0 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, First Line | 28.8 | 13.6 | Not reported | Not reported | Not reported |
Day 127
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 54 |
| Primary Expansion Cohort: NSCLC, First Line | 0 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 45 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 29 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 6 |
| Secondary Expansion Cohort: Colorectal Cancer | 1 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 3 |
| Secondary Expansion Cohort: Melanoma | 13 |
| Secondary Expansion Cohort: Mesothelioma | 13 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 0 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 0 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 13 |
| Secondary Expansion Cohort: Ovarian Cancer | 31 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 0 |
| Efficacy Expansion Cohort: HNSCC | 0 |
| Efficacy Expansion Cohort: Ovarian Cancer | 0 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 36.9 | 24.0 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 39.1 | 40.2 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 33.1 | 24.0 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 28.8 | 22.1 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 34.2 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 44.2 | 12.7 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 58.6 | 76.7 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 25.9 | 11.3 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 35.7 | 18.2 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 40.7 | 25.1 | Not reported | Not reported | Not reported |
Day 169
| Group | Source count |
|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 49 |
| Primary Expansion Cohort: NSCLC, First Line | 10 |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 27 |
| Primary Expansion Cohort: Metastatic Breast Cancer | 19 |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 3 |
| Secondary Expansion Cohort: Colorectal Cancer | 1 |
| Secondary Expansion Cohort: Castrate-resistant Prostate Cancer | 0 |
| Secondary Expansion Cohort: Melanoma | 12 |
| Secondary Expansion Cohort: Mesothelioma | 13 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 34 |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 1 |
| Secondary Expansion Cohort: Urothelial Carcinoma | 13 |
| Secondary Expansion Cohort: Ovarian Cancer | 22 |
| Efficacy Expansion Cohort: GC/GEJC, Third Line | 0 |
| Efficacy Expansion Cohort: HNSCC | 6 |
| Efficacy Expansion Cohort: Ovarian Cancer | 3 |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 36.6 | 25.8 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: NSCLC, First Line | 39.1 | 19.8 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed) | 31.4 | 18.2 | Not reported | Not reported | Not reported |
| Primary Expansion Cohort: Metastatic Breast Cancer | 31.9 | 14.0 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Adrenocortical Carcinoma | 24.7 | 28.1 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Colorectal Cancer | 10.5 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Melanoma | 35.3 | 20.2 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Mesothelioma | 28.7 | 11.4 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) | 47.1 | 26.8 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) | 43.6 | Not reported | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Urothelial Carcinoma | 38.8 | 19.2 | Not reported | Not reported | Not reported |
| Secondary Expansion Cohort: Ovarian Cancer | 49.3 | 27.3 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: HNSCC | 32.5 | 14.7 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Ovarian Cancer | 28.3 | 20.0 | Not reported | Not reported | Not reported |
| Efficacy Expansion Cohort: Urothelial Carcinoma | 37.3 | 31.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.1
- value
- 20.4
- group Id
- OG001
- spread
- 10.3
- value
- 18.3
- group Id
- OG002
- spread
- 11.1
- value
- 22.5
- group Id
- OG003
- spread
- 24.6
- value
- 23.7
- group Id
- OG004
- spread
- 9.51
- value
- 17.8
- group Id
- OG005
- spread
- 14.1
- value
- 22.4
- group Id
- OG006
- spread
- 14.5
- value
- 28.8
- group Id
- OG007
- spread
- 13.4
- value
- 22.3
- group Id
- OG008
- spread
- 26.7
- value
- 21.7
- group Id
- OG009
- spread
- 14.4
- value
- 26.9
- group Id
- OG010
- spread
- 11.6
- value
- 25.1
- group Id
- OG011
- spread
- 12.0
- value
- 21.3
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 124
- group Id
- OG002
- value
- 129
- group Id
- OG003
- value
- 154
- group Id
- OG004
- value
- 32
- group Id
- OG005
- value
- 17
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 45
- group Id
- OG008
- value
- 48
- group Id
- OG009
- value
- 57
- group Id
- OG010
- value
- 16
- group Id
- OG011
- value
- 43
- units
- Participants
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 15.4
- value
- 23.5
- group Id
- OG001
- spread
- 15.1
- value
- 23.5
- group Id
- OG002
- spread
- 15.2
- value
- 25.6
- group Id
- OG003
- spread
- 17.0
- value
- 26.5
- group Id
- OG004
- spread
- 13.6
- value
- 17.3
- group Id
- OG005
- spread
- 20.1
- value
- 25.5
- group Id
- OG006
- spread
- 15.9
- value
- 31.6
- group Id
- OG007
- spread
- 17.3
- value
- 23.8
- group Id
- OG008
- spread
- 12.4
- value
- 20.7
- group Id
- OG009
- spread
- 22.3
- value
- 35.7
- group Id
- OG010
- spread
- 16.6
- value
- 27.4
- group Id
- OG011
- spread
- 16.9
- value
- 26.2
- denoms
- counts
- group Id
- OG000
- value
- 149
- group Id
- OG001
- value
- 109
- group Id
- OG002
- value
- 117
- group Id
- OG003
- value
- 142
- group Id
- OG004
- value
- 28
- group Id
- OG005
- value
- 17
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 41
- group Id
- OG008
- value
- 45
- group Id
- OG009
- value
- 50
- group Id
- OG010
- value
- 15
- group Id
- OG011
- value
- 38
- units
- Participants
- title
- Day 29
- categories
- measurements
- group Id
- OG000
- spread
- 15.6
- value
- 24.6
- group Id
- OG001
- spread
- 15.9
- value
- 23.8
- group Id
- OG002
- spread
- 18.2
- value
- 28.3
- group Id
- OG003
- spread
- 17.8
- value
- 29.7
- group Id
- OG004
- spread
- 14.3
- value
- 20.6
- group Id
- OG005
- spread
- 24.2
- value
- 23.2
- group Id
- OG006
- spread
- 16.3
- value
- 32.3
- group Id
- OG007
- spread
- 22.9
- value
- 29.3
- group Id
- OG008
- spread
- 18.9
- value
- 23.6
- group Id
- OG009
- spread
- 22.6
- value
- 35.7
- group Id
- OG010
- spread
- 19.7
- value
- 29.4
- group Id
- OG011
- spread
- 18.9
- value
- 28.1
- denoms
- counts
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 96
- group Id
- OG002
- value
- 94
- group Id
- OG003
- value
- 96
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 34
- group Id
- OG008
- value
- 37
- group Id
- OG009
- value
- 51
- group Id
- OG010
- value
- 17
- group Id
- OG011
- value
- 33
- units
- Participants
- title
- Day 43
- categories
- measurements
- group Id
- OG000
- spread
- 17.3
- value
- 26.2
- group Id
- OG001
- spread
- 16.1
- value
- 23.4
- group Id
- OG002
- spread
- 14.1
- value
- 26.5
- group Id
- OG003
- spread
- 14.5
- value
- 28.9
- group Id
- OG004
- spread
- 19.8
- value
- 22.2
- group Id
- OG007
- spread
- 22.4
- value
- 29.9
- group Id
- OG008
- spread
- 11.7
- value
- 18.2
- group Id
- OG009
- spread
- 25.5
- value
- 39.8
- group Id
- OG010
- spread
- 18.7
- value
- 25.5
- group Id
- OG011
- spread
- 22.8
- value
- 29.7
- group Id
- OG012
- spread
- 21.5
- value
- 27.3
- group Id
- OG013
- spread
- 15.2
- value
- 16.2
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 86
- group Id
- OG002
- value
- 86
- group Id
- OG003
- value
- 78
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 26
- group Id
- OG008
- value
- 36
- group Id
- OG009
- value
- 46
- group Id
- OG010
- value
- 15
- group Id
- OG011
- value
- 30
- units
- Participants
- title
- Day 57
- categories
- measurements
- group Id
- OG000
- spread
- 36.5
- value
- 27.9
- group Id
- OG001
- spread
- 40.1
- value
- 31.0
- group Id
- OG002
- spread
- 16.6
- value
- 28.1
- group Id
- OG003
- spread
- 15.4
- value
- 29.9
- group Id
- OG004
- spread
- 15.5
- value
- 22.0
- group Id
- OG007
- spread
- 23.6
- value
- 28.8
- group Id
- OG008
- spread
- 14.2
- value
- 21.0
- group Id
- OG009
- spread
- 33.4
- value
- 38.4
- group Id
- OG010
- spread
- 17.6
- value
- 27.8
- group Id
- OG011
- spread
- 22.1
- value
- 29.4
- group Id
- OG012
- spread
- 31.8
- value
- 33.4
- group Id
- OG013
- spread
- 15.3
- value
- 19.6
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 73
- group Id
- OG002
- value
- 83
- group Id
- OG003
- value
- 70
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 27
- group Id
- OG008
- value
- 33
- group Id
- OG009
- value
- 46
- group Id
- OG010
- value
- 13
- group Id
- OG011
- value
- 24
- units
- Participants
- title
- Day 71
- categories
- measurements
- group Id
- OG000
- spread
- 18.9
- value
- 27.8
- group Id
- OG001
- spread
- 16.7
- value
- 27.7
- group Id
- OG002
- spread
- 18.1
- value
- 29.7
- group Id
- OG003
- spread
- 16.8
- value
- 28.9
- group Id
- OG004
- spread
- 29.0
- value
- 24.9
- group Id
- OG005
- spread
- 0.988
- value
- 8.03
- group Id
- OG006
- spread
- 18.3
- value
- 37.9
- group Id
- OG007
- spread
- 23.7
- value
- 35.6
- group Id
- OG008
- spread
- 15.8
- value
- 23.7
- group Id
- OG009
- spread
- 27.2
- value
- 39.7
- group Id
- OG010
- spread
- 20.2
- value
- 34.4
- group Id
- OG011
- spread
- 20.5
- value
- 34.7
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 67
- group Id
- OG003
- value
- 43
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 22
- group Id
- OG008
- value
- 24
- group Id
- OG009
- value
- 43
- group Id
- OG010
- value
- 11
- group Id
- OG011
- value
- 23
- units
- Participants
- title
- Day 85
- categories
- measurements
- group Id
- OG001
- spread
- 13.6
- value
- 28.8
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Day 99
- categories
- measurements
- group Id
- OG000
- spread
- 24.0
- value
- 36.9
- group Id
- OG002
- spread
- 40.2
- value
- 39.1
- group Id
- OG003
- spread
- 24.0
- value
- 33.1
- group Id
- OG004
- spread
- 22.1
- value
- 28.8
- group Id
- OG005
- value
- 34.2
- group Id
- OG006
- spread
- 12.7
- value
- 44.2
- group Id
- OG007
- spread
- 76.7
- value
- 58.6
- group Id
- OG008
- spread
- 11.3
- value
- 25.9
- group Id
- OG011
- spread
- 18.2
- value
- 35.7
- group Id
- OG012
- spread
- 25.1
- value
- 40.7
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 29
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 13
- group Id
- OG008
- value
- 13
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 13
- units
- Participants
- title
- Day 127
- categories
- measurements
- group Id
- OG000
- spread
- 25.8
- value
- 36.6
- group Id
- OG001
- spread
- 19.8
- value
- 39.1
- group Id
- OG002
- spread
- 18.2
- value
- 31.4
- group Id
- OG003
- spread
- 14.0
- value
- 31.9
- group Id
- OG004
- spread
- 28.1
- value
- 24.7
- group Id
- OG005
- value
- 10.5
- group Id
- OG007
- spread
- 20.2
- value
- 35.3
- group Id
- OG008
- spread
- 11.4
- value
- 28.7
- group Id
- OG009
- spread
- 26.8
- value
- 47.1
- group Id
- OG010
- value
- 43.6
- group Id
- OG011
- spread
- 19.2
- value
- 38.8
- group Id
- OG012
- spread
- 27.3
- value
- 49.3
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 13
- group Id
- OG009
- value
- 34
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 13
- units
- Participants
- title
- Day 169
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 124
- group Id
- OG002
- value
- 129
- group Id
- OG003
- value
- 154
- group Id
- OG004
- value
- 32
- group Id
- OG005
- value
- 17
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 45
- group Id
- OG008
- value
- 48
- group Id
- OG009
- value
- 57
- group Id
- OG010
- value
- 17
- group Id
- OG011
- value
- 43
- units
- Participants
- description
- Serum Ctrough concentration of Avelumab is reported.
- dispersion Type
- Standard Deviation
- 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 gastric and gastroesophageal cancer who progressed/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
- OG002
- title
- Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed)
- 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
- OG003
- title
- Primary Expansion Cohort: Metastatic Breast 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
- OG004
- title
- Secondary Expansion Cohort: Adrenocortical Carcinoma
- 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 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
- OG007
- 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
- OG008
- title
- Secondary Expansion Cohort: Mesothelioma
- description
- 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.
- id
- OG009
- title
- Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
- description
- 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.
- id
- OG010
- title
- Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
- 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
- OG011
- title
- Secondary Expansion Cohort: Urothelial Carcinoma
- param Type
- MEAN
- population Description
- Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data for "primary expansion cohort: GC/GEJC Progressed" and "primary expansion cohort: GC/GEJC Non progressed" arms was reported as a single arm "primary expansion cohort: GC/GEJC Progressed/Non progressed" for this outcome measure as per planned analysis.
- reporting Status
- POSTED
- time Frame
- At Day 15, 29, 43, 57, 71, 85, 99, 127 and 169
- title
- Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
- type
- SECONDARY
- unit Of Measure
- Microgram per milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice