Eligibility, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs)Primary· From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
32.6
19.5 – 48.0
Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Gastrointestinal Adverse Events (AEs)Secondary· From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
21.7
10.9 – 36.4
Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Hepatobiliary Adverse EventsSecondary· From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
4.3
0.5 – 14.8
Number of Participants Who Died, Who Died Due to Related Adverse Events (AEs), and With Related AEs, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to AEs and Related AEs, Immune-related (ir) AEs, and Serious irAEsSecondary· From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Deaths
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
4
Deaths due to related AEs
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
0
SAEs
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
31
Related SAEs
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
18
Discontinuations due to AEs
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
18
Discontinuations due to related AEs
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
16
irAEs
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
43
Serious irAEs
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
10
Number of Participants With Adverse Events (AEs) Grade 3-4, Related AEs Grade 3-4, Related Serious Adverse Events (SAEs) Grade 3-4, Immune-related (ir) AEs Grade 3-4, and Serious irAEs Grade 3-4Secondary· From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.
AEs Grade 3-4
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
39
Related AEs Grade 3-4
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
30
Related SAEs Grade 3-4
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
17
irAEs Grade 3-4
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
25
Serious irAEs Grade 3-4
Group
Value
95% CI
Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
9
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs with onset date on or after Day 1 of study therapy and within the last dose of Vem1 + 14 days, last dose of Ipi Phase + 90 days, last dose of Vem2 + 14 days. Up to July 2014 (approximately 21 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Vemurafenib, 960 mg + Ipilimumab,10 mg/kg ab
Serious: 34/46 (74%)
Deaths: —
Serious adverse events (53 terms)
Reaction
System
Vemurafenib, 960 mg + Ipil…
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Colitis
Gastrointestinal disorders
—
Asthenia
General disorders
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Back pain
Musculoskeletal and connective tissue disorders
—
Dehydration
Metabolism and nutrition disorders
—
Headache
Nervous system disorders
—
Vomiting
Gastrointestinal disorders
—
Diarrhoea
Gastrointestinal disorders
—
Hypotension
Vascular disorders
—
Pain
General disorders
—
Abdominal pain
Gastrointestinal disorders
—
Dysphagia
Gastrointestinal disorders
—
Pyrexia
General disorders
—
Haemorrhage Intracranial
Nervous system disorders
—
Hepatitis
Hepatobiliary disorders
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Renal failure
Renal and urinary disorders
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Abasia
General disorders
—
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 2
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· recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 24 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01673854.