Trial Outcomes & Findings for Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083) (NCT NCT00749684)

NCT ID: NCT00749684

Last Updated: 2015-10-19

Results Overview

Number of participants with disease recurrence was being measured.

• Recruitment status: COMPLETED
• Target enrollment: 138 participants
• Primary outcome timeframe: Throughout 12 months of treatment and 24 months of follow-up
• Results posted on: 2015-10-19

Participant Flow

Male and female participants, with malignant melanoma Stage II or III (>1.5 mm tumor thickness, no distant metastasis) or malignant melanoma with evidence of lymph node metastis or lymph node metastasis of malignant melanoma at unknown primary tumor, primary tumor has to be surgically resected within 2 months after first biopsy/excision.

Participant milestones

Measure	Adults With Malignant Melanoma at High Risk of Relapse Adults with malignant melanoma of the following stages: * II and III (\>/= 1.5 mm Breslow thickness without distant metastases * melanoma with lymph node metastases
Overall Study STARTED	138
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	82

Reasons for withdrawal

Measure	Adults With Malignant Melanoma at High Risk of Relapse Adults with malignant melanoma of the following stages: * II and III (\>/= 1.5 mm Breslow thickness without distant metastases * melanoma with lymph node metastases
Overall Study Death	1
Overall Study Adverse Event	27
Overall Study Participant's Wish	10
Overall Study Not Documented	1
Overall Study Progressive Desease	31
Overall Study Therapy according to protocol + AE	2
Overall Study AE+discontinuation on participants wish	1
Overall Study Missing	9

Baseline Characteristics

Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)

Baseline characteristics by cohort

Measure	Adults With Malignant Melanoma at High Risk of Relapse n=138 Participants Adults with malignant melanoma of the following stages: * II and III (\>/= 1.5 mm Breslow thickness without distant metastases * melanoma with lymph node metastases
Age, Continuous Total	48.83 participants STANDARD_DEVIATION 12.72 • n=5 Participants
Age, Continuous Male	49.15 participants STANDARD_DEVIATION 12.91 • n=5 Participants
Age, Continuous Female	48.27 participants STANDARD_DEVIATION 12.49 • n=5 Participants
Sex: Female, Male Female	50 Participants 12.49 • n=5 Participants
Sex: Female, Male Male	88 Participants 12.91 • n=5 Participants

PRIMARY outcome

Timeframe: Throughout 12 months of treatment and 24 months of follow-up

Population: 138 participants with malignant melanoma, 88 male participants and 50 female participants were evaluated.

Number of participants with disease recurrence was being measured.

Outcome measures

Measure	Adults With Malignant Melanoma at High Risk of Relapse n=138 Participants Adults with malignant melanoma of the following stages: * II and III (\>/= 1.5 mm Breslow thickness without distant metastases * melanoma with lymph node metastases
Number of Participants With Disease Recurrence	52 participants

PRIMARY outcome

Timeframe: Throughout 12 months of treatment and 24 months of follow-up

Median time to recurrence according to Kaplan Maier evaluation

Outcome measures

Measure	Adults With Malignant Melanoma at High Risk of Relapse n=138 Participants Adults with malignant melanoma of the following stages: * II and III (\>/= 1.5 mm Breslow thickness without distant metastases * melanoma with lymph node metastases
Relapse Free Survival Time	54.1 months Interval 0.0 to 60.0

Adverse Events

Interferon Alfa-2b

Serious events: 11 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Measure	Interferon Alfa-2b n=138 participants at risk
General disorders DEATH	0.72% 1/138 • Number of events 1
Immune system disorders SARCOIDOSIS	0.72% 1/138 • Number of events 1
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.72% 1/138 • Number of events 1
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.72% 1/138 • Number of events 1
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.72% 1/138 • Number of events 1
Nervous system disorders EPILEPSY	0.72% 1/138 • Number of events 1
Psychiatric disorders DEPRESSION	1.4% 2/138 • Number of events 2
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.72% 1/138 • Number of events 1
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.72% 1/138 • Number of events 1
Vascular disorders VENOUS THROMBOSIS	0.72% 1/138 • Number of events 1

Other adverse events

Measure	Interferon Alfa-2b n=138 participants at risk
Blood and lymphatic system disorders LEUKOPENIA	9.4% 13/138 • Number of events 20
Gastrointestinal disorders NAUSEA	8.7% 12/138 • Number of events 13
General disorders FATIGUE	9.4% 13/138 • Number of events 20
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	8.7% 12/138 • Number of events 17
Investigations LIVER FUNCTION TEST ABNORMAL	12.3% 17/138 • Number of events 19
Investigations TRANSAMINASES INCREASED	5.8% 8/138 • Number of events 9
Metabolism and nutrition disorders DECREASED APPETITE	5.1% 7/138 • Number of events 9
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	5.1% 7/138 • Number of events 7
Nervous system disorders HEADACHE	6.5% 9/138 • Number of events 9
Psychiatric disorders DEPRESSION	10.1% 14/138 • Number of events 14
Skin and subcutaneous tissue disorders ALOPECIA EFFLUVIUM	5.1% 7/138 • Number of events 7

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp and Dohme Corp.

Phone: 1-800-672-6372

Email: clinicaltrialsdisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place