Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the Neo-adjuvant Use of Vemurafenib Plus Cobimetinib (GDC-0973) in Patients With BRAF Mutant Melanoma With Palpable Lymph Node Metastases.
Brief Summary: This study will evaluate the clinical and pathological response to vemurafenib and cobimetinib in the neoadjuvant treatment of patients with histologically confirmed, BRAF V600 mutation-positive Stage IIIB and C melanoma. 20 patients will be treated with vemurafenib and cobimetinib for 2 months. Then they will be assessed for surgery. Patients will undergo surgery and subsequently resume taking vemurafenib and cobimetinib after recovery from surgery. Patients will undergo radiation therapy if appropriate then continue vemurafenib and cobimetinib. The maximum treatment period is 12 months. After 12 months of treatment, patients will be followed for disease recurrence and survival during for a total of 5 years.


Options:
A: Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib (Day 15); Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites (Day 15); Part B: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) (From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)); Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline (From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)); Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range (From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)); Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline (From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)); Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range (From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)); Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure (From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)); Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator (From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)); Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response Assessed by Blinded Independent Central Review (BICR) (From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 19 months)); Part C (Crossover): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator (From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)); Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Investigator (From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)); Part C (Crossover): Progression-free Survival (PFS) as Assessed by the Investigator (From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)); Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Blinded Independent Central Review (BICR) (From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 19 months)); Part C (Randomized): Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR) (First documented evidence of PR or CR until the date of the first documented sign of disease progression or the date of death due to any cause (up to approximately 19 months)); Part C (Randomized): Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part D (Analyte=GSK2118436): Maximum Plasma Concentration (Cmax) of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib (Day 1 and Day 21); Part D (Analyte=GSK2118436): Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib (Day 1 and Day 21); Part D (Analyte=GSK2118436): AUC (0-tau) and AUC (0-inf) of Single and Repeat Doses of Dabrafenib Alone and in Combination With Trametinib (Day 1 and Day 21); Part D: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)); Part D: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure (From Baseline (Day 1) until Follow-up visit (up to approximately 7 years))
B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
C: The feasibility of treating patients with unresectable melanoma and palpable lymph node metastases that harbor the BRAF mutation with neoadjuvant vemurafenib. (24 months)
D: Overall Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)

Answer: C