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Vemurafenib/Cobimetinib for Melanoma

Phase 2
Waitlist Available
Led By Sekwon Jang, MD
Research Sponsored by Inova Health Care Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 56 (+/- 3 days)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

Neoadjuvant Vemurafenib and Cobimetinib in BRAF V600 Mutant Stage IIIB-C Melanoma • To evaluate the overall radiological complete response rate in patients with stage IIIB/C melanoma after 8 weeks of neoadjuvant vemurafenib and cobimetinib

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 56 (+/- 3 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 56 (+/- 3 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiologic Complete Response Rate
Secondary study objectives
Overall response rate, pathologic complete response rate

Side effects data

From 2015 Phase 3 trial • 675 Patients • NCT01006980
56%
Arthralgia
48%
Alopecia
47%
Fatigue
43%
Rash
40%
Photosensitivity Reaction
39%
Nausea
37%
Diarrhoea
34%
Headache
29%
Hyperkeratosis
29%
Skin Papilloma
26%
Pruritus
24%
Dry Skin
23%
Decreased Appetite
23%
Pain In Extremity
22%
Vomiting
21%
Pyrexia
20%
Squamous cell carcinoma of skin
18%
Erythema
17%
Sunburn
16%
Dysgeusia
16%
Back Pain
15%
Constipation
15%
Oedema Peripheral
15%
Asthenia
15%
Myalgia
15%
Cough
14%
Seborrhoeic Keratosis
13%
Actinic Keratosis
13%
Musculoskeletal Pain
12%
Melanocytic Naevus
12%
Dizziness
12%
Skin Lesion
11%
Keratoacanthoma
11%
Abdominal Pain Upper
11%
Nasopharyngitis
11%
Insomnia
10%
Blood Alkaline Phosphatase Increased
10%
Anaemia
10%
Weight Decreased
10%
Dyspnoea
10%
Abdominal Pain
10%
Keratosis Pilaris
10%
Palmar-Plantar Erythrodysaesthesia Syndrome
10%
Rash Maculo-Papular
9%
Influenza Like Illness
9%
Blood Bilirubin Increased
9%
Pain
9%
Paraesthesia
8%
Oropharyngeal Pain
8%
Blood Creatinine Increased
8%
Dermal Cyst
8%
Chest Pain
8%
Peripheral Swelling
8%
Alanine Aminotransferase Increased
8%
Folliculitis
7%
Chills
7%
Gamma-Glutamyltransferase Increased
7%
Aspartate Aminotransferase Increased
6%
Dyspepsia
6%
Conjunctivitis
6%
Upper Respiratory Tract Infection
6%
Depression
5%
Abdominal Distension
5%
Dermatitis Acneiform
5%
Influenza
5%
Hyperaesthesia
5%
Skin Exfoliation
5%
Flushing
4%
Acne
3%
Rash erythematous
3%
Basal cell carcinoma
3%
Urinary tract infection
2%
Malignant melanoma
2%
Lower respiratory tract infection
1%
Seizure
1%
Abdominal pain
1%
Thrombocytopenia
1%
Dehydration
1%
Pleuritic pain
1%
Pulmonary embolism
1%
Uveitis
1%
Pancreatitis
1%
Atrial fibrillation
1%
Myocardial infarction
1%
Chest pain
1%
Pneumonia
1%
Blood bilirubin increased
1%
Gamma-glutamyltransferase increased
1%
Acute kidney injury
1%
Pleural effusion
1%
Blood alkaline phosphatase increased
1%
Gastrointestinal haemorrhage
1%
Bowen's disease
1%
Loss of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vemurafenib
Vemurafenib After Crossover
Dacarbazine

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vemurafenib/CobimetinibExperimental Treatment1 Intervention
Vemurafenib and cobimetinib as a combination has been approved by the United States Food and Drug Administration (FDA) for patients with more advanced melanoma. In this trial, vemurafenib and cobimetinib combination is considered to be experimental since safety of this combination prior to lymph node surgery has not been studied.

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,563 Previous Clinical Trials
570,089 Total Patients Enrolled
34 Trials studying Melanoma
1,772 Patients Enrolled for Melanoma
Inova Health Care ServicesLead Sponsor
73 Previous Clinical Trials
22,479 Total Patients Enrolled
1 Trials studying Melanoma
40 Patients Enrolled for Melanoma
Sekwon Jang, MDPrincipal InvestigatorInova Schar Cancer Institute
~0 spots leftby Nov 2025
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