Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)
Brief Summary: This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after prior therapy.

Initial Treatment Period:

Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab, higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an open-label fashion.

The starting pembrolizumab dose was initially blinded to Investigators and participants until Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of pembrolizumab.

Switch-to-Pembrolizumab Treatment Period:

Participants who were initially randomized to receive ICC and experienced progressive disease (PD) may have been eligible to switch to receiving pembrolizumab provided they met protocol-specified requirements for switching. Qualified participants were re-randomized to receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03, all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab.


Options:
A: Arm Label: Pembrolizumab 2 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Pembrolizumab 10 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Investigator-Choice Chemotherapy (ICC); Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Drug: Paclitaxel, Drug: Dacarbazine, Drug: Temozolomide | Arm Label: ICC→Pembrolizumab 2 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: Dacarbazine, Drug: Temozolomide | Arm Label: ICC→Pembrolizumab 10 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: Dacarbazine, Drug: Temozolomide | Intervention Type: BIOLOGICAL; Name: Pembrolizumab; Assigned to Arm(s): ICC→Pembrolizumab 10 mg/kg, ICC→Pembrolizumab 2 mg/kg, Pembrolizumab 10 mg/kg, Pembrolizumab 2 mg/kg | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): ICC→Pembrolizumab 10 mg/kg, ICC→Pembrolizumab 2 mg/kg, Investigator-Choice Chemotherapy (ICC) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): ICC→Pembrolizumab 10 mg/kg, ICC→Pembrolizumab 2 mg/kg, Investigator-Choice Chemotherapy (ICC) | Intervention Type: DRUG; Name: Dacarbazine; Assigned to Arm(s): ICC→Pembrolizumab 10 mg/kg, ICC→Pembrolizumab 2 mg/kg, Investigator-Choice Chemotherapy (ICC) | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): ICC→Pembrolizumab 10 mg/kg, ICC→Pembrolizumab 2 mg/kg, Investigator-Choice Chemotherapy (ICC)
B: Arm Label: Temozolomide (TMZ); Type: EXPERIMENTAL; Interventions: Drug: Temozolomide (TMZ) | Arm Label: Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI); Type: EXPERIMENTAL; Interventions: Drug: Temozolomide (TMZ), Drug: Pegylated Interferon Alpha-2b (PGI) | Intervention Type: DRUG; Name: Temozolomide (TMZ); Assigned to Arm(s): Temozolomide (TMZ), Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI) | Intervention Type: DRUG; Name: Pegylated Interferon Alpha-2b (PGI); Assigned to Arm(s): Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI)
C: Arm Label: Dostarlimab (TSR-042) (singly); Type: EXPERIMENTAL; Interventions: Drug: Dostarlimab (TSR-042) (singly) | Arm Label: Dostarlimab (TSR-042) and Cobolimab TSR-022 (combination); Type: EXPERIMENTAL; Interventions: Drug: Dostarlimab (TSR-042) and TSR-022 (combination) | Intervention Type: DRUG; Name: Dostarlimab (TSR-042) (singly); Assigned to Arm(s): Dostarlimab (TSR-042) (singly) | Intervention Type: DRUG; Name: Dostarlimab (TSR-042) and TSR-022 (combination); Assigned to Arm(s): Dostarlimab (TSR-042) and Cobolimab TSR-022 (combination)
D: Arm Label: Nivolumab, 3 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: BMS-936558 (Nivolumab), Drug: Placebo matching Dacarbazine | Arm Label: Dacarbazine, 1000 mg/m^2; Type: ACTIVE_COMPARATOR; Interventions: Biological: Placebo matching BMS-936558 (Nivolumab), Drug: Dacarbazine | Intervention Type: BIOLOGICAL; Name: BMS-936558 (Nivolumab); Assigned to Arm(s): Nivolumab, 3 mg/kg | Intervention Type: BIOLOGICAL; Name: Placebo matching BMS-936558 (Nivolumab); Assigned to Arm(s): Dacarbazine, 1000 mg/m^2 | Intervention Type: DRUG; Name: Dacarbazine; Assigned to Arm(s): Dacarbazine, 1000 mg/m^2 | Intervention Type: DRUG; Name: Placebo matching Dacarbazine; Assigned to Arm(s): Nivolumab, 3 mg/kg

Answer: A