- |||||||||| Zelboraf (vemurafenib) / Roche
Trial primary completion date, Combination therapy, Metastases: Vemurafenib and TIL Therapy for Metastatic Melanoma (clinicaltrials.gov) - Oct 11, 2018 P1/2, N=12, Active, not recruiting, Trial primary completion date: Aug 2018 --> Dec 2018
- |||||||||| Journal: Update on hairy cell leukemia. (Pubmed Central) - Sep 28, 2018
Rituximab has limited activity as a single agent but achieves high complete remission rates without minimal residual disease when combined with purine analogues, albeit with chemotherapy-associated toxicity. Investigational nonchemotherapy options include moxetumomab pasudotox, which targets CD22; vemurafenib or dabrafenib, each of which targets the BRAF V600E protein; trametinib, which targets mitogen-activated protein kinase enzyme (MEK); and ibrutinib, which targets Bruton tyrosine kinase (BTK).
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment closed, PD(L)-1 Biomarker, Metastases: IMspire150: A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma (clinicaltrials.gov) - Sep 24, 2018 P3, N=513, Active, not recruiting, Investigational nonchemotherapy options include moxetumomab pasudotox, which targets CD22; vemurafenib or dabrafenib, each of which targets the BRAF V600E protein; trametinib, which targets mitogen-activated protein kinase enzyme (MEK); and ibrutinib, which targets Bruton tyrosine kinase (BTK). Recruiting --> Active, not recruiting
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases: Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib (clinicaltrials.gov) - Sep 19, 2018 P1/2, N=18, Terminated, Recruiting --> Active, not recruiting N=38 --> 18 | Trial completion date: Jun 2020 --> Sep 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2019 --> Jun 2018; Loss of funding
- |||||||||| Xalkori (crizotinib) / Pfizer, Zelboraf (vemurafenib) / Roche
Enrollment change, Trial completion date, Combination therapy, Metastases: Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF Mutations (clinicaltrials.gov) - Sep 17, 2018 P1, N=183, Active, not recruiting, N=38 --> 18 | Trial completion date: Jun 2020 --> Sep 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2019 --> Jun 2018; Loss of funding N=46 --> 183 | Trial completion date: Feb 2021 --> Feb 2020
- |||||||||| Zelboraf (vemurafenib) / Roche
Journal: Cutaneous wound healing through paradoxical MAPK activation by BRAF inhibitors. (Pubmed Central) - Sep 6, 2018 Here we show how the BRAF inhibitor vemurafenib accelerates skin wound healing by inducing the proliferation and migration of human keratinocytes through extracellular signal-regulated kinase (ERK) phosphorylation and cell cycle progression...The same dosing regimen of topical BRAF inhibitor does not increase the incidence of cutaneous squamous cell carcinomas in mice. Therefore, topical BRAF inhibitors may have clinical applications in accelerating the healing of skin wounds.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, Metastases: Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma (clinicaltrials.gov) - Aug 2, 2018 P1, N=50, Recruiting, Additionally, antigenic stimulation of the immune system by melanoma itself could contribute to clonal selection of lymphocytes. Trial completion date: Oct 2018 --> Oct 2019 | Trial primary completion date: Jun 2018 --> Jun 2019
- |||||||||| Zelboraf (vemurafenib) / Roche
Enrollment closed, Combination therapy, Metastases: Vemurafenib and TIL Therapy for Metastatic Melanoma (clinicaltrials.gov) - Jul 2, 2018 P1/2, N=12, Active, not recruiting, Vemurafenib showed activity in patients with advanced melanoma with rarer BRAF mutations. Recruiting --> Active, not recruiting
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche
Trial completion date, Trial primary completion date, Metastases: Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib (clinicaltrials.gov) - Jun 26, 2018 P1/2, N=38, Active, not recruiting, Recruiting --> Active, not recruiting Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Jun 2018 --> Jun 2019
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Zelboraf (vemurafenib) / Roche
Clinical, Journal, PD(L)-1 Biomarker, IO biomarker: Exceptional Response with Immunotherapy in a Patient with Anaplastic Thyroid Cancer. (Pubmed Central) - Jun 9, 2018 N=150 --> 300 Programmed death-1 (PD-1)/PD-L1 immunotherapy has shown evidence of durable responses in certain malignancies such as melanoma, lung cancer, and renal cell carcinoma.PD-L1 positive tumors promote autoimmunity against the tumor; therefore, PD-1/PD-L1 blockade may be beneficial.Molecular profiling could possibly result in improved targeted therapy for certain malignancies.
- |||||||||| Opdivo (nivolumab) / BMS, Braftovi (encorafenib) / Pfizer, Mektovi (binimetinib) / Pfizer
Enrollment open: Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma (clinicaltrials.gov) - Jun 6, 2018 P1, N=20, Recruiting, Programmed death-1 (PD-1)/PD-L1 immunotherapy has shown evidence of durable responses in certain malignancies such as melanoma, lung cancer, and renal cell carcinoma.PD-L1 positive tumors promote autoimmunity against the tumor; therefore, PD-1/PD-L1 blockade may be beneficial.Molecular profiling could possibly result in improved targeted therapy for certain malignancies. Not yet recruiting --> Recruiting
- |||||||||| Trial completion date, Trial primary completion date, Tumor mutational burden, PD(L)-1 Biomarker: My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors (clinicaltrials.gov) - Jun 1, 2018
P2a, N=600, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Aug 2019 --> Aug 2020 | Trial primary completion date: Aug 2019 --> Aug 2020
- |||||||||| Zelboraf (vemurafenib) / Roche
Preclinical, Journal: BRAF fusion as a novel mechanism of acquired resistance to vemurafenib in BRAF V600E mutant melanoma. (Pubmed Central) - May 13, 2018 We report acquisition of a BRAF fusion as a novel mechanism of acquired resistance to vemurafenib in a patient with melanoma harboring a BRAF(V600E) mutation. The acquisition and regression of clones harboring this fusion during the presence and absence of a BRAF inhibitor are consistent with rapidly evolving clonal dynamics in melanoma.
- |||||||||| Proleukin (aldesleukin) / Clinigen, Novartis, Prometheus, Zelboraf (vemurafenib) / Roche
Clinical, P2 data, Journal, PD(L)-1 Biomarker, IO biomarker: A phase II study of combined therapy with a BRAF inhibitor (vemurafenib) and interleukin-2 (aldesleukin) in patients with metastatic melanoma. (Pubmed Central) - May 4, 2018 P2 Given the efficacy of regimens targeting the PD-1 pathway, strategies combining these regimens with BRAF-targeted therapy are currently underway, and the role of combination vemurafenib and HD-IL-2 is uncertain. Trial Registration: Clinical trial information: NCT01754376; https://clinicaltrials.gov/show/NCT01754376.
- |||||||||| Zelboraf (vemurafenib) / Roche
Journal: CRAF R391W is a melanoma driver oncogene. (Pubmed Central) - May 3, 2018 This cell line demonstrated a signaling profile similar to BRAF-mutants, but lacked sensitivity to the BRAF inhibitor vemurafenib...MAP kinase inducing activity was dependent on CRAF dimerization. Thus, CRAF is a bona fide alternative oncogene for BRAF/NRAS/GNAQ/GNA11 wild type melanomas.
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche
Trial primary completion date, Metastases: REPOSIT: Vemurafenib Plus Cobimetinib in Metastatic Melanoma (clinicaltrials.gov) - May 2, 2018 P2, N=90, Recruiting, Thus, CRAF is a bona fide alternative oncogene for BRAF/NRAS/GNAQ/GNA11 wild type melanomas. Trial primary completion date: Dec 2017 --> Dec 2018
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, IO biomarker, Metastases: ImmunoCobiVem: Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma (clinicaltrials.gov) - Apr 27, 2018 P2, N=176, Recruiting, Trial primary completion date: Dec 2017 --> Dec 2018 Trial completion date: Jun 2020 --> Dec 2021 | Trial primary completion date: Mar 2020 --> Sep 2021
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment open, PD(L)-1 Biomarker, Metastases: IMspire150: A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma (clinicaltrials.gov) - Apr 18, 2018 P3, N=500, Recruiting, Trial completion date: Jun 2020 --> Dec 2021 | Trial primary completion date: Mar 2020 --> Sep 2021 Active, not recruiting --> Recruiting
- |||||||||| Zelboraf (vemurafenib) / Roche
Biomarker, Trial completion date, Trial primary completion date, Metastases: Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial) (clinicaltrials.gov) - Apr 12, 2018 P2, N=49, Recruiting, Active, not recruiting --> Recruiting Trial completion date: Apr 2022 --> Dec 2023 | Trial primary completion date: Apr 2022 --> Dec 2023
- |||||||||| Biomarker, Trial completion date, Trial primary completion date, BRCA Biomarker, PARP Biomarker, Metastases: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - Apr 12, 2018
P2, N=1500, Recruiting, Trial completion date: Apr 2022 --> Dec 2023 | Trial primary completion date: Apr 2022 --> Dec 2023 Trial completion date: Dec 2021 --> Sep 2027 | Trial primary completion date: Dec 2021 --> Sep 2027
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche, Tecentriq (atezolizumab) / Roche
Enrollment closed, PD(L)-1 Biomarker, Metastases: IMspire150: A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma (clinicaltrials.gov) - Apr 5, 2018 P3, N=500, Active, not recruiting, Recruiting --> Suspended Recruiting --> Active, not recruiting
- |||||||||| Torisel (temsirolimus) / Pfizer, Zelboraf (vemurafenib) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer (clinicaltrials.gov) - Apr 3, 2018 P1, N=114, Active, not recruiting, Practical recommendations derived from clinical experience are provided for management of key drug-related toxicities. Trial completion date: Dec 2018 --> Dec 2020 | Trial primary completion date: Dec 2018 --> Dec 2019
- |||||||||| Zelboraf (vemurafenib) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Vemurafenib and TIL Therapy for Metastatic Melanoma (clinicaltrials.gov) - Mar 19, 2018 P1/2, N=12, Recruiting, Trial completion date: Mar 2018 --> Mar 2019 Trial completion date: Nov 2017 --> Aug 2020 | Trial primary completion date: Nov 2016 --> Aug 2018
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