- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: Targeted Therapy in Head and Neck Cancer: An Update on Current Clinical Developments in Epidermal Growth Factor Receptor-Targeted Therapy and Immunotherapies. (Pubmed Central) - Jun 21, 2017 As a result, cetuximab, a monoclonal antibody targeting epidermal growth factor receptor, as well as pembrolizumab and nivolumab, monoclonal antibodies targeting programmed cell death 1 (PD-1), are now US Food and Drug Administration approved for the treatment of R/M HNSCC. This review will detail the data supporting the use of these agents, as well as clinical trials evaluating the efficacy of other novel and promising drugs.
- |||||||||| telisotuzumab (h224G11) / AbbVie
Trial completion, Enrollment change, Metastases: Study of ABT-700 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Jun 7, 2017 P1, N=74, Completed, Trial primary completion date: May 2017 --> May 2019 Active, not recruiting --> Completed | N=124 --> 74
- |||||||||| EGFR bi-armed autologous activated T cells / Barbara Ann Karmanos Cancer Institute
Trial primary completion date, IO biomarker, Metastases: Anti-CD3 x Anti-Erbitux (clinicaltrials.gov) - May 31, 2017 P1, N=30, Active, not recruiting, Suspended --> Recruiting | N=120 --> 51 | Initiation date: Feb 2014 --> Aug 2016 | Trial primary completion date: Aug 2017 --> Nov 2017 Trial primary completion date: Jul 2016 --> Jan 2019
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck. (Pubmed Central) - May 27, 2017 The major development of the past decade in the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) was the introduction of cetuximab in combination with platinum plus 5-fluorouracil chemotherapy (CT), followed by maintenance cetuximab (the "EXTREME" regimen)...Nivolumab and pembrolizumab are the first two ICIs that were approved by the US Food and Drug Administration...A number of ongoing clinical trials are comparing regimens with ICIs, alone and in combination with other ICIs or CT, with the EXTREME regimen for first-line treatment of R/M SCCHN. As we eagerly await the results of these trials, the EXTREME regimen remains the standard of care for the first-line treatment of R/M SCCHN.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, buparlisib (AN2025) / Novartis, Adlai Nortye
Biomarker, Trial primary completion date, Combination therapy, Metastases: PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (clinicaltrials.gov) - May 23, 2017 P1/2, N=30, Active, not recruiting, As we eagerly await the results of these trials, the EXTREME regimen remains the standard of care for the first-line treatment of R/M SCCHN. Trial primary completion date: Apr 2017 --> Apr 2018
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment closed, Trial primary completion date: Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer (clinicaltrials.gov) - May 22, 2017 P2, N=63, Active, not recruiting, Trial primary completion date: Apr 2017 --> Apr 2018 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2016 --> Nov 2015
- |||||||||| IMM-101 / Immodulon
Enrollment open, Trial initiation date, Trial primary completion date, Combination therapy, Metastases: Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer (clinicaltrials.gov) - May 22, 2017 P1/2, N=300, Recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2016 --> Nov 2015 Not yet recruiting --> Recruiting | Initiation date: Jan 2017 --> May 2017 | Trial primary completion date: Jan 2019 --> May 2019
- |||||||||| lapatinib / Generic mfg., Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Review, Journal: ASCO Plenary Sessions: impact, legacy, future. (Pubmed Central) - May 20, 2017 Who could have forseen bevacizumab displaced by several VEGF TKIs? Third, negative trials are rare among Plenary sessions, but when they are presented they are immensely important. Examples include a seminal study using CA-125 levels to guide treatment of relapsed ovarian cancer, the use of lapatinib combined with traztuzumab in the adjuvant treatment of HER2 + disease, and studies showing no survival benefit to upfront bevacizumab in glioblastoma multiforme. Fourth, we note a large industry presence among Plenary sessions, as the Industry in part sponsored 62% of Plenary abstracts. Ultimately a review of 9 years of ASCO plenary reveals the plenary for what it is: a conservative selection of abstracts that, at the time, are thought to change the face of oncology. Time, however, is the true arbiter, and some succeed in this quest, while others falter. ASCO plenary sessions reveal the influence, legacy and future of cancer care.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Biomarker, Trial completion, Trial primary completion date, Combination therapy, IO biomarker, Metastases: Biomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy (clinicaltrials.gov) - May 17, 2017 P2, N=69, Completed, Not yet recruiting --> Completed Not yet recruiting --> Completed | Trial primary completion date: Feb 2012 --> Sep 2010
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Targeting pathways mediating resistance to anti-EGFR therapy in squamous cell carcinoma of the head and neck. (Pubmed Central) - May 12, 2017 This review summarizes the results of recently completed trials of anti-EGFR agents in SCCHN, highlights the various mechanisms that drive resistance to EGFR inhibitors in SCCHN, and focuses on several novel targeted agents that could potentially help overcome resistance to EGFR-based therapies in SCCHN. Expert commentary: Due to the development of resistance to EGFR-targeted therapies, novel treatment approaches to overcome resistance are a key unmet need for SCCHN.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, Zelboraf (vemurafenib) / Roche
Enrollment closed, Enrollment change, Combination therapy, Surgery, Metastases: Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery (clinicaltrials.gov) - May 11, 2017 P1, N=46, Active, not recruiting, Expert commentary: Due to the development of resistance to EGFR-targeted therapies, novel treatment approaches to overcome resistance are a key unmet need for SCCHN. Recruiting --> Active, not recruiting | N=33 --> 46
- |||||||||| Imjudo (tremelimumab) / AstraZeneca, Pfizer, Imfinzi (durvalumab) / AstraZeneca
Enrollment closed, Combination therapy, Metastases: KESTREL: Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - May 9, 2017 P3, N=823, Active, not recruiting, N=25 --> 1 Recruiting --> Active, not recruiting
- |||||||||| Stivarga (regorafenib) / Bayer
Trial primary completion date, Combination therapy, Metastases: Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination (clinicaltrials.gov) - May 4, 2017 P1b, N=44, Active, not recruiting, The diagnostic and therapeutic convergence radiopharmaceutical (64)Cu-/(177)Lu-PCTA-cetuximab may be useful as a diagnostic tool in patient selection and a potent radioimmunotherapy agent in EGFR-positive ESCC tumors. Trial primary completion date: Jan 2017 --> Aug 2017
- |||||||||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial primary completion date, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) (clinicaltrials.gov) - May 1, 2017 P2, N=105, Recruiting, Although alcohol consumption was not associated with colon cancer outcomes overall, mild to moderate red wine consumption was suggestively associated with longer OS, DFS, and TTR in stage III colon cancer patients. Trial primary completion date: Apr 2017 --> Jul 2017
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion, Trial primary completion date: Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab (clinicaltrials.gov) - Apr 27, 2017 P=N/A, N=100, Completed, Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Mar 2016 --> Apr 2017
- |||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, LEAC-102 / Taiwan Bio
Trial initiation date, Combination therapy, Metastases: LEAC-102 for Advanced Colorectal Cancer (clinicaltrials.gov) - Apr 26, 2017 P1/2, N=30, Not yet recruiting, Active, not recruiting --> Completed | Trial primary completion date: Mar 2016 --> Apr 2017 Initiation date: Feb 2017 --> Jun 2017
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, tivantinib (ARQ 197) / Daiichi Sankyo, Kyowa Kirin, Merck (MSD)
Trial primary completion date, Surgery, Metastases: Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery (clinicaltrials.gov) - Apr 25, 2017 P2, N=76, Active, not recruiting, Initiation date: Feb 2017 --> Jun 2017 Trial primary completion date: Dec 2016 --> Dec 2017
- |||||||||| Erbitux (cetuximab) / Eli Lilly, Zelboraf (vemurafenib) / Roche
Trial primary completion date, Combination therapy, Surgery, Metastases: Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery (clinicaltrials.gov) - Apr 21, 2017 P1, N=33, Recruiting, The combination demonstrated early signals of activity in wild-type CRC, including 1 exceptional responder with MSI high. Trial primary completion date: Feb 2018 --> Feb 2019
|