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An Open-Label, Single-arm, Multicenter Phase I Study of SCH 54031 (Pegylated Interferon Alfa-2b) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (Protocol No. MK-4031 370 Also Known as SCH 54031, P08556)


Phase 1
20 Years
75 Years
Open (Enrolling)
Both
Malignant Melanoma

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Trial Information

An Open-Label, Single-arm, Multicenter Phase I Study of SCH 54031 (Pegylated Interferon Alfa-2b) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (Protocol No. MK-4031 370 Also Known as SCH 54031, P08556)


Inclusion Criteria:



- Stage II or III melanoma

- Primary melanoma completely excised

- Full lymphadenectomy within 84 days prior to initiation of study treatment

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

- Ocular melanoma or melanoma of the mucous membranes

- Evidence of distant or non-regional lymph node metastases

- In-transit melanoma

- Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy,
radiotherapy or immunotherapy/vaccine for melanoma

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose-limiting toxicities (DLTs)

Outcome Time Frame:

From first dose through 8 weeks

Safety Issue:

Yes

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

P08556

NCT ID:

NCT01636960

Start Date:

December 2012

Completion Date:

October 2018

Related Keywords:

  • Malignant Melanoma
  • Melanoma

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