Clinical Trials Using Dabrafenib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Dabrafenib. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-21 of 21
  • Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1172 locations

  • Dabrafenib and Trametinib in Treating Patients with Stage III-IV BRAF Mutant Melanoma That Cannot Be Removed by Surgery

    This randomized phase II trial studies how well dabrafenib and trametinib work in treating patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf proto-oncogene, serine / threonine kinase (BRAF) mutation. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 620 locations

  • Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients with Stage III-IV BRAFV600 Melanoma

    This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
    Location: 600 locations

  • A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

    To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma
    Location: 11 locations

  • Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

    This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell tumor / non-geminomatous germ cell tumor, hairy cell leukemia, World Health Organization (WHO) Grade 1 or 2 glioma, WHO Grade 3 or 4 (high-grade) glioma, multiple myeloma, and adenocarcinoma of the small intestine, with BRAF V600E positive-mutations. This study is designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects will need to have a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status. Only subjects with histologically confirmed advanced disease and no available standard treatment options will be eligible for enrollment. Subjects will undergo screening assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease assessments) prior to the start of treatment to determine their eligibility for enrollment in the study.
    Location: 8 locations

  • Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations

    This is a 4-part (Part A, Part B, Part C and Part D), Phase I / IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors. Part A is a repeat dose, dose escalation monotherapy study that will identify the recommended phase II dose (RP2D) on the continuous dosing schedule using a 3 + 3 dose- escalation procedure. Part B will evaluate the preliminary activity of trametinib monotherapy in 4 disease-specific cohorts of subjects. Each cohort will enroll at least 10 response-evaluable subjects (evaluable for response is defined as a subject with a pre-dose and at least 1 post-dose disease assessment or clinical assessment of progression of disease). Part C is will be a 3+3 study design to determine the safety, tolerability and preliminary activity of the RP2D of trametinib in combination with a limited dose escalation of dabrafenib. Part C will enroll up to 24 subjects. Part D will evaluate the preliminary activity of trametinib in combination with dabrafenib in 2 disease-specific cohorts of subjects diagnosed with LGG and LCH. LGG cohort will enroll approximately 20 response-evaluable subjects and the LCH cohort will enroll approximately 10 response-evaluable subjects. The overall goal of this trial is to efficiently establish safe, pharmacologically relevant dose of trametinib monotherapy and trametinib in combination with dabrafenib in infants, children and adolescents and determine preliminary activity of trametinib monotherapy and trametinib in combination with dabrafenib in selected recurrent, refractory or unresectable childhood tumors.
    Location: 6 locations

  • A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects

    This is a 2-part, study to determine the safety, tolerability and pharmacokinetics of oral dabrafenib in children and adolescent subjects with advanced BRAF V600 mutation-positive solid tumors. Part 1 (dose escalation study) will identify the recommended Part 2 (tumor-specific expansion study) dose and regimen using a dose-escalation procedure. Approximately 6 to 18 subjects will participate in Part 1 and will receive a starting dose of 3 mg / kg and dose will deescalate or escalate between 1.5 milligram (mg) / kilogram (kg) and 6 mg / kg. Up to 6 subjects will be enrolled at one dose level dependent upon the number of subjects at the current dose level, the number of subjects who have experienced a dose limiting toxicity (DLT) at the current dose level, and the number of subjects enrolled but with data pending at the current dose level. Escalation may proceed until either a maximum tolerated dose (MTD) is established, or until the dose in which the median pharmacokinetic parameters consistent with exposure in adults are achieved. Cohorts may be added in order to evaluate additional dose levels. Part 2 consists of four disease-specific cohorts of subjects with tumors known to have BRAF V600 activation (pediatric low-grade gliomas, pediatric high-grade gliomas, Langerhans cell histiocytosis [LCH], and other tumors such as melanoma and papillary thyroid carcinoma [PTC]). Each cohort will enroll at least 10 subjects with a pre-dose and at least 1 post-dose disease assessment. In both the parts of the study, on Day 1, a single first dose will be administered, and repeat dosing will begin on Day 2. PK sampling will be performed on Day 1 and Day 15 for subjects >=25 kg in weight. For subjects <25 kg and >=10 kg in weight, blood samples for PK analysis will be collected on Day 1 and Day 15. For subjects <10kg in weight, blood samples for PK analysis will be collected after repeated administration on Day 15 only. Safety and tolerability will be assessed throughout the study. Treatment with dabrafenib will be continued until disease progression or until no clinical benefit or development of an unacceptable toxicity, or until they withdraw consent or begin a new therapy. At the end of treatment, a final study visit will occur.
    Location: 6 locations

  • Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG and LGG

    The purpose of this study is to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma or relapsed or refractory high grade glioma.
    Location: 4 locations

  • Dabrafenib, Trametinib and Hydroxychloroquine in Treating Patients with Stage IV Metastatic Melanoma

    This phase I / II trial studies the side effects and best dose of hydroxychloroquine when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IV melanoma that has spread to other places in the body. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes when dabrafenib and trametinib are given, the tumor cells activate a stress response called autophagy. Autophagy provides resistance to dabrafenib and trametinib treatment over time making them less effective. Giving hydroxychloroquine with dabrafenib and trametinib may reduce drug resistance and allow more tumor cells to be killed.
    Location: 4 locations

  • A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022 / KEYNOTE-022)

    This is a 5-part dose-finding and preliminary efficacy study of pembrolizumab (Pembro) + dabrafenib (D) + trametinib (T) for participants with advanced melanoma. Parts 1 and 2 are open-label to find and confirm the maximum tolerated dose (MTD) / maximum administered dose (MAD) for Pembro+D+T. The primary hypothesis (Parts 1 and 2) is that Pembro+D+T is sufficiently well-tolerated to permit clinical investigation. Part 3 is a double-blind study of Pembro+D+T versus placebo+D+T. The primary study hypothesis (Part 3 only) is that the Pembro+D+T improves progression-free survival (PFS) compared with placebo+D+T. Part 4 is nonrandomized and open-label and is designed to evaluate the safety and tolerability and identify the MTD or MAD of Pembro+T in participants who have v-raf murine sarcoma viral oncogene homolog B1 [BRAF] mutation-negative (without V600 E or K) melanoma or solid tumors [irrespective of BRAF status]. The primary hypothesis (Part 4) is that Pembro+T is sufficiently well-tolerated to permit clinical investigation. Part 5 will confirm the dose(s) identified in Part 4 in participants BRAF wild type [without V600E or K] melanoma or solid tumors [irrespective of BRAF status] and will further evaluate the safety and preliminary efficacy (Objective Response Rate [ORR]) of Pembro+T in participants who have BRAF wild type [without V600E or K] melanoma only. The primary hypotheses (Part 5) are that Pembro+T is sufficiently well-tolerated at the MTD / MAD to permit further clinical investigation and is effective in attaining objective responses based upon Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator review in participants who have melanoma without BRAF V600 E or K mutations. Parts 1 and 2 of the study will also explore the MTD / MAD for open-label Pembro+T (for BRAF mutation-negative participants) concurrently with the Pembro+D+T arm; Pembro+D (for BRAF mutation-positive participants).
    Location: 3 locations

  • Dabrafenib, Trametinib, and Navitoclax in Treating Patients with BRAF Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

    This partially randomized phase I / II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with v-raf murine sarcoma viral oncogene homolog B (BRAF) mutant melanoma or solid tumors that have spread to other parts of the body or cannot be removed by surgery. Dabrafenib, trametinib, and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • MCS110, Dabrafenib, and Trametinib in Treating Participants with BRAF V600E or V600K Mutated Melanoma

    This phase I / II trial studies the best dose and side effects of anti-M-CSF monoclonal antibody MCS110 (MCS110) and how well it works when given together with dabrafenib and trametinib in treating participants with BRAF V600E or V600K mutated melanoma. Monoclonal antibodies, such as MCS110, may interfere with the ability of tumor cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving MCS110, dabrafenib and trametinib may work better at treating BRAF V600E or V600K mutated melanoma.
    Location: 2 locations

  • Phenformin Hydrochloride, Dabrafenib, and Trametinib in Treating Patients with Stage III-IV BRAF V600E / K-Mutated Melanoma

    This phase I trial studies the side effects and best dose of phenformin hydrochloride when given together with dabrafenib and trametinib in treating patients with stage III-IV BRAF V600E / K-mutated melanoma. Phenformin hydrochloride may work by shrinking the tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving phenformin hydrochloride, dabrafenib, and trametinib may work better at treating melanoma and might prevent the tumor from becoming resistant to treatment.
    Location: 3 locations

  • Dabrafenib and / or Trametinib Rollover Study

    This study is to provide access for patients who are receiving treatment with dabrafenib and / or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment n the parent study as judged by the Investigator at the completion of the parent study.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Pembrolizumab and Trametinib with or without Dabrafenib in Treating Patients with Melanoma That Is Metastatic or Cannot Be Removed by Surgery

    This phase II trial studies how well pembrolizumab and trametinib with or without dabrafenib work in treating patients with melanoma that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Trametinib and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and trametinib with or without dabrafenib may work better in treating patients with melanoma.
    Location: 2 locations

  • Nivolumab and Trametinib with or without Dabrafenib in Treating Patients with BRAF or NRAS-Mutated Metastatic Stage III-IV Melanoma That Cannot Be Removed by Surgery

    This phase II trial studies the side effects and how well nivolumab and trametinib with or without dabrafenib work in treating patients with BRAF or NRAS-mutated stage III-IV melanoma that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Trametinib and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if nivolumab and trametinib with or without dabrafenib may work better in treating patients with BRAF or NRAS-mutated metastatic melanoma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Dabrafenib and Trametinib in Treating Patients with BRAF Mutated Ameloblastoma

    This pilot phase II trial studies how well dabrafenib and trametinib work in treating patients with ameloblastoma and a specific mutation (change) in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Dabrafenib and Trametinib before and after Surgery in Treating Patients with Stage IIIB-C Melanoma with BRAF V600 Mutation

    This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving dabrafenib and trametinib after surgery may kill any remaining tumor cells.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Onalespib, Dabrafenib, and Trametinib in Treating Patients with BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

    This phase I trial studies the side effects and best dose of onalespib when given together with dabrafenib and trametinib in treating patients with BRAF-mutant melanoma or solid tumors that have spread to another place in the body (metastatic) or cannot be removed by surgery. Onalespib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • Dabrafenib and Trametinib in Treating Patients with Erdheim Chester Disease and BRAF Mutation

    This phase II trial studies the side effects and how well dabrafenib and trametinib work in treating patients with Erdheim Chester disease that have a mutation in the proto-oncogene B-Raf (BRAF) gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment

    To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri