Clinical trial · Interventional
Radiation Use During Vemurafenib Treatment
Radiation Use During Vemurafenib and Cobimetinib Treatment in Patients With BRAFV600 Mutated Stage IV or Unresectable Stage III Melanoma
NCT01843738CI-TRIAL-00027768withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Competing Trials
Summary
Brief summary (as posted)
Patients are being asked to take part because they have melanoma that has spread to other organs in their body (metastatic). As part of this study, patients will receive radiation therapy and an approved drug (Vemurafenib).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAFV600 Mutation | — | UNRESOLVED | — |
| Stage IV Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
| Vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All participants
- interventionNames
- Radiation: Radiation therapy
- Drug: Vemurafenib
Primary outcomes (1)
- measure
- Number of patients with adverse events as a measure of safety and tolerability
- timeFrame
- 36 months
- description
- To evaluate the safety of radiation combined with vemurafenib treatment in patients with BRAFV600 mutated Stage IV or unresectable Stage III melanoma
Secondary outcomes (1)
- measure
- Response rate
- timeFrame
- 36 months
- description
- To evaluate response rates as assessed by RECIST criteria 1.1, at baseline, and at 8 week intervals throughout the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years old * Diagnosis of BRAFV600 mutated Stage IV or unresectable Stage III melanoma * Actively receiving treatment with vemurafenib as single agent and tolerating at least 720 mg bid for one cycle (28 days). * In the opinion of the investigator, patients who are progressing in an area where radiation may provide benefit from either: * Symptom control * Oligo-progression, defined as progression in up to 3 areas where focal treatment would provide benefit. * Patients with brain metastases will be allowed provided they meet all of the following criteria: * Small, \< 1cm metastases which are untreated are allowed so long as in the opinion of the investigator they do not require immediate treatment by radiation or surgery * Asymptomatic, treated brain metastases which are stable for 4 weeks prior to study entry are allowed * If patients are requiring steroids for their brain metastases, they must be on a stable dose for two weeks prior to study entry, and maintain that steroid dosing during the radiation treatments * Adequate bone marrow function as defined by: ANC \> 1.0 k/uL, Platelets \> 75 k/uL, Hemoglobin \> 8 g/dL * Adequate hepatic function: Total bilirubin \< 1.5 times the institutional upper limit of normal, ALT/AST \< 2.5 times the institutional upper limit of normal * Adequate renal function as defined by serum creatinin \< 1.5 times the upper limit of normal. * Negative serum pregnancy test at screening for women of child bearing potential within 10 days of starting vemurafenib treatment . Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for \> 1 year * Fertile men and women must agree to use an acceptable method of birth control during treatment and for at least 2 months after discontinuation of vemurafenib. * Able and willing to provide informed consent to an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * Screening QTc interval \> 450 msec on EKG * Known HIV positivity or AIDS-related illness, or active HBV, or active HCV. * Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension, cerebrovascular accident or transient ischemic attack, or symptomatic pulmonary embolism. * Malabsorption disorder that would preclude adequate vemurafenib absorption. * Other medical condition present that in the opinion of the investigator will hinder the subjects ability to complete the study.
References
Publications (0)
Data not yet available
No reference posted for this study.