Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
Brief Summary: This is a Phase 1, open-label, dose-escalation trial of avelumab \[antibody targeting programmed death ligand 1 (anti PD-L1)\] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts.

Active cohorts: Escalation revised dosing regimen cohort.

Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .


Options:
A: Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: paclitaxel, Drug: vinflunine, Drug: docetaxel | Arm Label: Pembrolizumab; Type: EXPERIMENTAL; Interventions: Biological: pembrolizumab | Intervention Type: BIOLOGICAL; Name: pembrolizumab; Assigned to Arm(s): Pembrolizumab | Intervention Type: DRUG; Name: paclitaxel; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: vinflunine; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: docetaxel; Assigned to Arm(s): Control
B: Arm Label: Nivolumab; Type: EXPERIMENTAL; Interventions: Drug: Nivolumab | Intervention Type: DRUG; Name: Nivolumab; Assigned to Arm(s): Nivolumab
C: Arm Label: Dose Escalation Cohort: Avelumab 1.0 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Dose Escalation Cohort: Avelumab 3.0 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Dose Escalation Cohort: Avelumab 10.0 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Dose Escalation Cohort: Avelumab 20.0 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Primary Expansion Cohort: NSCLC, Post-platinum Doublet; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Primary Expansion Cohort: NSCLC, First Line; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Primary Expansion Cohort: Metastatic Breast Cancer; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Primary Expansion Cohort: GC/GEJC Progressed; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Primary Expansion Cohort: GC/GEJC Non Progressed; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Colorectal Cancer; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Castrate-resistant Prostate Cancer; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Adrenocortical Carcinoma; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Melanoma; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Mesothelioma; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Urothelial Carcinoma; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Ovarian Cancer; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Renal Cell Carcinoma (First Line); Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line); Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Efficacy Expansion Cohort: Ovarian Cancer; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Efficacy Expansion Cohort: Urothelial Carcinoma; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Efficacy Expansion Cohort: GC/ GEJC, Third Line; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Arm Label: Efficacy Expansion Cohort: HNSCC; Type: EXPERIMENTAL; Interventions: Drug: Avelumab | Intervention Type: DRUG; Name: Avelumab; Assigned to Arm(s): Dose Escalation Cohort: Avelumab 1.0 mg/kg, Dose Escalation Cohort: Avelumab 10.0 mg/kg, Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly, Dose Escalation Cohort: Avelumab 20.0 mg/kg, Dose Escalation Cohort: Avelumab 3.0 mg/kg, Efficacy Expansion Cohort: GC/ GEJC, Third Line, Efficacy Expansion Cohort: HNSCC, Efficacy Expansion Cohort: Ovarian Cancer, Efficacy Expansion Cohort: Urothelial Carcinoma, Primary Expansion Cohort: GC/GEJC Non Progressed, Primary Expansion Cohort: GC/GEJC Progressed, Primary Expansion Cohort: Metastatic Breast Cancer, Primary Expansion Cohort: NSCLC, First Line, Primary Expansion Cohort: NSCLC, Post-platinum Doublet, Secondary Expansion Cohort: Adrenocortical Carcinoma, Secondary Expansion Cohort: Castrate-resistant Prostate Cancer, Secondary Expansion Cohort: Colorectal Cancer, Secondary Expansion Cohort: Melanoma, Secondary Expansion Cohort: Mesothelioma, Secondary Expansion Cohort: Ovarian Cancer, Secondary Expansion Cohort: Renal Cell Carcinoma (First Line), Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line), Secondary Expansion Cohort: Urothelial Carcinoma
D: Arm Label: Cohort A: Triple Negative Breast Cancer; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Cohort B: Head & Neck Cancer; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Cohort C: Urothelial Cancer; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Cohort D: Gastric Cancer; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Cohort B2: Head & Neck Cancer Expansion; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Intervention Type: BIOLOGICAL; Name: Pembrolizumab; Assigned to Arm(s): Cohort A: Triple Negative Breast Cancer, Cohort B2: Head & Neck Cancer Expansion, Cohort B: Head & Neck Cancer, Cohort C: Urothelial Cancer, Cohort D: Gastric Cancer

Answer: C