Condition

Malignant skin melanoma

Clinical trials and treatment information for Malignant skin melanoma

2.2M
People Affected
200
Active Trials
479K
New Cases/Year
62K
Deaths/Year

Treatment Rankings

Ranked by evidence volume first. Medicine has spent centuries ranking things by vibes. This is an improvement.

1
Nivolumab + Ipilimumab
93% Effectivenessβ€’ 95% Confidenceβ€’ 30% Safetyβ€’ 25 trialsβ€’ 5.5K participants
HIGH EvidencePoor ValueDose: Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV every 3 weeks for 4 doses, then Nivolumab 240 mg IV every 2 weeks or 480 mg IV every 4 weeks
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Comparative Safety Scale(Higher is safer)

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30
DangerousModerateSafe

Time to Effect

2-4 months

Duration

1-2 years

Response Rate

58%

Remission Rate

25%

Common Side Effects:

Fatigue: 55%
Diarrhea/Colitis: 45%
Rash/Pruritus: 45%
Nausea/Vomiting: 25%
Hepatitis: 15%
Endocrinopathies: 15%

Annual Cost of Care

Drug Cost

$300,000

Monitoring

$25,000

Side Effects

$30,000

Total Annual

$355,000

Cost-Effectiveness

POOR

QALYs Gained

3

ICER

$350,000/QALY

Cost per Remission

$1,420,000

Cost per Responder

$612,069

Treatment Outcomes
Primary Outcomes
Serum Lactate Dehydrogenase (LDH)500 U/L (elevated baseline)
-60% (-300 U/L)
Tumor Burden (Sum of Longest Diameters)100 mm (average baseline)
-60% (-60 mm)
Melanoma-Related Symptom Score (e.g., BPI Severity)5.0/10 (Brief Pain Inventory severity score)
-60% (-3.0/10)
Secondary Benefits
Global Health Status/QoL (EORTC QLQ-C30)60 points (typical for advanced melanoma)
+10% (+6 points)
Serum S100B Protein0.20 mcg/L (elevated baseline)
-50% (-0.10 mcg/L)
Common Side Effects
Fatigue
+55%
Diarrhea/Colitis
+45%
Rash/Pruritus
+45%

Clinical Trial Phases:

Phase 3Phase 4
2
Dabrafenib + Trametinib
91% Effectivenessβ€’ 92% Confidenceβ€’ 38% Safetyβ€’ 18 trialsβ€’ 5K participants
HIGH EvidencePoor ValueDose: Dabrafenib 150mg orally twice daily + Trametinib 2mg orally once daily
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Comparative Safety Scale(Higher is safer)

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38
DangerousModerateSafe

Time to Effect

1-2 months

Duration

1-2 years

Response Rate

65%

Remission Rate

15%

Common Side Effects:

Pyrexia (fever): 60%
Fatigue: 40%
Nausea, Diarrhea, Vomiting: 30%
Chills: 25%
Rash: 25%
Peripheral edema: 25%

Annual Cost of Care

Drug Cost

$320,000

Monitoring

$12,000

Side Effects

$10,000

Total Annual

$342,000

Cost-Effectiveness

POOR

QALYs Gained

2.5

ICER

$200,000/QALY

Cost per Remission

$2,280,000

Cost per Responder

$526,154

Treatment Outcomes
Primary Outcomes
Tumor Burden Reduction (RECIST Sum of Longest Diameters)100 mm (representative baseline for measurable disease)
-71% (-71 mm)
Serum Lactate Dehydrogenase (LDH) Level450 U/L (elevated, common in advanced melanoma)
-40% (-180 U/L)
Serum C-Reactive Protein (CRP) Level20 mg/L (elevated, normal <5 mg/L)
-50% (-10 mg/L)
Secondary Benefits
Global Health Status / Quality of Life Score (EORTC QLQ-C30)50/100 (typical for advanced cancer patients)
+15% (+7.5 points)
Pain Intensity (NRS-11 scale)6/10 (moderate to severe pain)
-33% (-2 points)
Fatigue Severity (FACIT-Fatigue Scale)25/52 (moderate fatigue)
+20% (+5 points)
Common Side Effects
Pyrexia (fever)
+60%
Fatigue
+40%
Nausea, Diarrhea, Vomiting
+30%

Clinical Trial Phases:

Phase 3Phase 4
3
Vemurafenib + Cobimetinib
90% Effectivenessβ€’ 92% Confidenceβ€’ 38% Safetyβ€’ 8 trialsβ€’ 5K participants
HIGH EvidencePoor ValueDose: Vemurafenib 960mg orally twice daily + Cobimetinib 60mg orally once daily (21 days on, 7 days off)
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Comparative Safety Scale(Higher is safer)

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38
DangerousModerateSafe

Time to Effect

1-2 months

Duration

1-2 years

Response Rate

65%

Remission Rate

15%

Common Side Effects:

Dermatological (rash, photosensitivity): 50%
Diarrhea: 45%
Nausea: 35%
Fatigue: 35%
Pyrexia: 35%
Arthralgia: 25%

Annual Cost of Care

Drug Cost

$300,000

Monitoring

$12,000

Side Effects

$10,000

Total Annual

$322,000

Cost-Effectiveness

POOR

QALYs Gained

2.5

ICER

$210,000/QALY

Cost per Remission

$2,146,667

Cost per Responder

$495,385

Treatment Outcomes
Primary Outcomes
Sum of Diameters of Target Lesions100 mm (representative initial tumor burden for RECIST evaluation)
-64% (-64 mm)
Median Progression-Free Survival (vs Vemurafenib monotherapy)7.2 months (median PFS with Vemurafenib monotherapy)
+70.8% (+5.1 months (increase))
Median Overall Survival (vs Vemurafenib monotherapy)17.4 months (median OS with Vemurafenib monotherapy)
+28.2% (+4.9 months (increase))
Secondary Benefits
Overall Response Rate (vs Vemurafenib monotherapy)50% (ORR with Vemurafenib monotherapy)
+40% (+20 percentage points (increase from 50% to 70%))
Median Duration of Response (vs Vemurafenib monotherapy)8.3 months (median DoR with Vemurafenib monotherapy)
+50.6% (+4.2 months (increase))
EORTC QLQ-C30 Global Health Status60 points (out of 100, typical for advanced melanoma patients)
+3.3% (+2 points (slight improvement/maintenance))
Common Side Effects
Dermatological (rash, photosensitivity)
+50%
Diarrhea
+45%
Nausea
+35%

Clinical Trial Phases:

Phase 3Phase 4
4
Pembrolizumab
88% Effectivenessβ€’ 90% Confidenceβ€’ 35% Safetyβ€’ 65 trialsβ€’ 12K participants
HIGH EvidencePoor ValueDose: 200mg IV every 3 weeks or 400mg IV every 6 weeks
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Comparative Safety Scale(Higher is safer)

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35
DangerousModerateSafe

Time to Effect

3-6 months

Duration

1-2 years

Response Rate

40%

Remission Rate

15%

Common Side Effects:

Fatigue: 40%
Pruritus (itchiness): 30%
Diarrhea: 20%
Rash: 20%
Nausea: 20%
Immune-related adverse events: 15%

Annual Cost of Care

Drug Cost

$170,000

Monitoring

$15,000

Side Effects

$10,000

Total Annual

$195,000

Cost-Effectiveness

POOR

QALYs Gained

2

ICER

$180,000/QALY

Cost per Remission

$1,300,000

Cost per Responder

$487,500

Treatment Outcomes
Primary Outcomes
Objective Response Rate (ORR)ORR with ipilimumab: 11.9%
+183.19% (+21.8 percentage points (from 11.9% to 33.7%))
Median Progression-Free Survival (PFS)Median PFS with ipilimumab: 4.3 months
+158.14% (+6.8 months (from 4.3 to 11.1 months))
2-Year Overall Survival Rate2-year OS with ipilimumab: 43%
+27.91% (+12 percentage points (from 43% to 55%))
Complete Response (CR) RateCR Rate with ipilimumab: 1%
+900% (+9 percentage points (from 1% to 10%))
Secondary Benefits
Global Health Status/QoL (EORTC QLQ-C30)Mean score: 72 (scale 0-100, higher is better)
0% (0 points (maintenance of baseline score))
Fatigue Severity (EORTC QLQ-C30 Fatigue Scale)Mean score: 35 (scale 0-100, lower is better)
-4.86% (-1.7 points)
Pain Severity (EORTC QLQ-C30 Pain Scale)Mean score: 25 (scale 0-100, lower is better)
-9.6% (-2.4 points)
Common Side Effects
Fatigue
+40%
Pruritus (itchiness)
+30%
Diarrhea
+20%

Clinical Trial Phases:

Phase 3Phase 4
5
Nivolumab
87% Effectivenessβ€’ 90% Confidenceβ€’ 35% Safetyβ€’ 48 trialsβ€’ 11K participants
HIGH EvidencePoor ValueDose: 240mg IV every 2 weeks or 480mg IV every 4 weeks
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Comparative Safety Scale(Higher is safer)

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Chemo☒️
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35
DangerousModerateSafe

Time to Effect

3-6 months

Duration

1-2 years

Response Rate

40%

Remission Rate

15%

Common Side Effects:

Fatigue: 40%
Rash: 30%
Diarrhea: 20%
Nausea: 20%
Pruritus: 20%
Immune-related adverse events: 15%

Annual Cost of Care

Drug Cost

$175,000

Monitoring

$15,000

Side Effects

$10,000

Total Annual

$200,000

Cost-Effectiveness

POOR

QALYs Gained

2

ICER

$185,000/QALY

Cost per Remission

$1,333,333

Cost per Responder

$500,000

Treatment Outcomes
Primary Outcomes
Median Progression-Free Survival3 months (historical control/chemotherapy in advanced melanoma)
+132% (+2.9 months)
Median Overall Survival12 months (historical control/chemotherapy in advanced melanoma)
+100% (+12 months)
Tumor Burden (Sum of Target Lesion Diameters, RECIST 1.1)100 mm (representative sum of diameters)
-40% (-40 mm)
Secondary Benefits
Median Duration of Response6 months (e.g., for chemotherapy responders)
+200% (+12 months)
Quality of Life (EORTC QLQ-C30 Global Health Status)65 points (on a 0-100 scale, higher is better)
+8% (+5 points)
Lactate Dehydrogenase (LDH)350 U/L (elevated, normal <250 U/L)
-30% (-105 U/L)
Common Side Effects
Fatigue
+40%
Rash
+30%
Diarrhea
+20%

Clinical Trial Phases:

Phase 3Phase 4
6
Talimogene laherparepvec (T-VEC)
75% Effectivenessβ€’ 80% Confidenceβ€’ 60% Safetyβ€’ 4 trialsβ€’ 1.2K participants
MODERATE EvidencePoor ValueDose: Intralesional injection. Initial dose 10^6 PFU/mL, subsequent doses 10^8 PFU/mL. Up to 4 mL per visit.
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Comparative Safety Scale(Higher is safer)

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60
DangerousModerateSafe

Time to Effect

2-4 months

Duration

6 months or until progression

Response Rate

20%

Remission Rate

8%

Common Side Effects:

Fatigue: 55%
Chills: 45%
Fever: 45%
Nausea: 35%
Flu-like symptoms: 25%
Injection site pain/cellulitis: 25%

Annual Cost of Care

Drug Cost

$80,000

Monitoring

$7,000

Side Effects

$3,000

Total Annual

$90,000

Cost-Effectiveness

POOR

QALYs Gained

0.8

ICER

$280,000/QALY

Cost per Remission

$1,125,000

Cost per Responder

$450,000

Treatment Outcomes
Primary Outcomes
Sum of Longest Diameters (SLD) of Injected Lesions100 mm
-81.2% (-81.2 mm)
Sum of Longest Diameters (SLD) of Non-Injected Lesions50 mm
-19.3% (-9.65 mm)
Median Overall Survival18.9 months
+23.3% (+4.4 months)
Median Progression-Free Survival6.7 months
+22.4% (+1.5 months)
Secondary Benefits
Global Health Status/QoL (EORTC QLQ-C30)70 points (out of 100)
+5% (+3.5 points)
Pain Interference Score (BPI, 0-10)4/10
-15% (-0.6 points)
Serum Lactate Dehydrogenase (LDH)300 U/L
-15% (-45 U/L)
Common Side Effects
Fatigue
+55%
Chills
+45%
Fever
+45%

Clinical Trial Phases:

Phase 3Phase 4