Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief Summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.


Options:
A: Arm Label: Arm 1: neoadjuvant + surgery; Type: EXPERIMENTAL; Interventions: Drug: L19IL2 + L19TNF, Procedure: Surgery | Arm Label: Arm 2: surgery alone; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Surgery | Intervention Type: DRUG; Name: L19IL2 + L19TNF; Assigned to Arm(s): Arm 1: neoadjuvant + surgery | Intervention Type: PROCEDURE; Name: Surgery; Assigned to Arm(s): Arm 1: neoadjuvant + surgery, Arm 2: surgery alone
B: Arm Label: Ipilimumab and Placebo matching Nivolumab; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Other: Placebo matching Nivolumab | Arm Label: Nivolumab and Placebo matching Ipilimumab; Type: EXPERIMENTAL; Interventions: Drug: Nivolumab, Other: Placebo matching Ipilimumab | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): Ipilimumab and Placebo matching Nivolumab | Intervention Type: DRUG; Name: Nivolumab; Assigned to Arm(s): Nivolumab and Placebo matching Ipilimumab | Intervention Type: OTHER; Name: Placebo matching Ipilimumab; Assigned to Arm(s): Nivolumab and Placebo matching Ipilimumab | Intervention Type: OTHER; Name: Placebo matching Nivolumab; Assigned to Arm(s): Ipilimumab and Placebo matching Nivolumab
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: MDX-010 (anti-CTLA4) monoclonal antibody, Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: MDX-010 (anti-CTLA4) monoclonal antibody | Intervention Type: DRUG; Name: MDX-010 (anti-CTLA4) monoclonal antibody; Assigned to Arm(s): 2, 3 | Intervention Type: BIOLOGICAL; Name: MDX-1379 (gp100) Melanoma Peptide Vaccine; Assigned to Arm(s): 1, 2
D: Arm Label: Ipilimumab 10 mg/kg + HDI; Type: EXPERIMENTAL; Interventions: Drug: administration of ipilimumab10mg/kg | Arm Label: Ipilimumab 3mg/kg + HDI; Type: EXPERIMENTAL; Interventions: Drug: administration of ipilimumab 3mg/kg + HDI | Intervention Type: DRUG; Name: administration of ipilimumab10mg/kg; Assigned to Arm(s): Ipilimumab 10 mg/kg + HDI | Intervention Type: DRUG; Name: administration of ipilimumab 3mg/kg + HDI; Assigned to Arm(s): Ipilimumab 3mg/kg + HDI

Answer: C