- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, alisertib (MLN8237) / Puma
Trial completion, Combination therapy, Metastases: MLN8237 in Head and Neck Cancer (clinicaltrials.gov) - Aug 29, 2018
P1, N=9, Completed,
Active, not recruiting --> Completed
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment closed, Trial primary completion date, Metastases: Nordic 8 - A Phase II Trial (clinicaltrials.gov) - Aug 27, 2018
P2, N=180, Active, not recruiting,
Initiation date: Nov 2016 --> Nov 2018 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Aug 2019
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / BMS, Imbruvica (ibrutinib) / AbbVie, J&J
New P2 trial, Combination therapy, IO biomarker, Metastases: Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC (clinicaltrials.gov) - Aug 23, 2018
P2, N=39, Not yet recruiting,
- |||||||||| cixutumumab (IMC A12) / Eli Lilly, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Biomarker, Trial completion, Enrollment change: Preoperative Treatment With Cetuximab and/or IMC-A12 (clinicaltrials.gov) - Aug 21, 2018
P2, N=16, Completed,
Initiation date: May 2018 --> Sep 2018 | Trial primary completion date: Jul 2019 --> Oct 2019 Active, not recruiting --> Completed | N=60 --> 16
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion date, Trial primary completion date: NKEXPHNC: Reactivating NK Cells in Treating Refractory Head and Neck Cancer (clinicaltrials.gov) - Aug 21, 2018
P1/2, N=31, Recruiting,
Active, not recruiting --> Completed | N=60 --> 16 Trial completion date: Jul 2018 --> Aug 2019 | Trial primary completion date: Jul 2018 --> Aug 2019
- |||||||||| epacadostat (INCB024360) / Incyte
Enrollment change, Trial completion date, Trial primary completion date, Monotherapy, Metastases: Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304) (clinicaltrials.gov) - Aug 15, 2018
P3, N=89, Active, not recruiting,
Trial completion date: Jan 2019 --> Jan 2020 | Trial primary completion date: Dec 2018 --> Dec 2019 N=625 --> 89 | Trial completion date: Apr 2021 --> Jun 2020 | Trial primary completion date: Jan 2021 --> Jul 2018
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer (clinicaltrials.gov) - Aug 13, 2018
P3, N=82, Active, not recruiting,
Trial completion date: Jun 2018 --> Jan 2019 Recruiting --> Active, not recruiting | N=164 --> 82 | Trial completion date: Jun 2019 --> Aug 2023 | Trial primary completion date: Jun 2017 --> Nov 2018
- |||||||||| Enrollment open, Metastases: QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine (clinicaltrials.gov) - Aug 10, 2018
P1/2, N=382, Recruiting,
Recruiting --> Active, not recruiting | N=164 --> 82 | Trial completion date: Jun 2019 --> Aug 2023 | Trial primary completion date: Jun 2017 --> Nov 2018 Not yet recruiting --> Recruiting
- |||||||||| Ojemda (tovorafenib) / Day One Biopharma, alisertib (MLN8237) / Puma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies (clinicaltrials.gov) - Aug 6, 2018
P1b, N=81, Completed,
Trial completion date: Jun 2018 --> Dec 2019 | Trial primary completion date: Jun 2018 --> Jun 2019 Active, not recruiting --> Completed | N=125 --> 81 | Trial completion date: Dec 2018 --> Jul 2018 | Trial primary completion date: Dec 2018 --> Jul 2018
- |||||||||| Bavencio (avelumab) / EMD Serono, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment open, Combination therapy, Monotherapy, Metastases: EACH: Evaluating Avelumab in Combination With Cetuximab in Head and Neck Cancer (clinicaltrials.gov) - Aug 6, 2018
P2, N=130, Recruiting,
Active, not recruiting --> Completed | N=125 --> 81 | Trial completion date: Dec 2018 --> Jul 2018 | Trial primary completion date: Dec 2018 --> Jul 2018 Not yet recruiting --> Recruiting
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
Journal: Correlation of Ki-67 Proliferative Antigen Expression and Tumor Response to Induction Chemotherapy Containing Cell Cycle-Specific Agents in Head and Neck Squamous Cell Carcinoma. (Pubmed Central) - Jul 29, 2018
IC included either nab-paclitaxel, cisplatin, 5-FU and cetuximab (APF-C, n = 27) or docetaxel, cisplatin, 5-FU +/- cetuximab (TPF+/-C, n = 32)...In multivariate regression analysis (MVA) controlling for p16 positive oropharyngeal SCC status and smoking status, Ki-67 expression was not significantly associated with tumor response by visual examination (coefficient estimate -0.002, standard error 0.010, p = 0.84), CT (coefficient estimate -0.007, standard error 0.011, p = 0.54), FDG-PET/CT (coefficient estimate 0.006, standard error 0.008, p = 0.51), the percent decrease in summed SUVmax (coefficient estimate 0.389, standard error 0.222, p = 0.09), or relapse events (OR = 1.02(95%CI:0.99-1.05), p = 0.28). No significant relationships were found in MVA between pretreatment Ki-67 expression and tumor response to IC or to relapse.
- |||||||||| Ixempra (ixabepilone) - Otsuka, R / Pharm, Allarity Therap, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion date, Trial primary completion date: Neo-Adjuvant Study in Triple Negative Breast Cancer Patients (clinicaltrials.gov) - Jul 26, 2018
P2, N=40, Active, not recruiting,
FGS has the potential to improve post-resection morbidity and mortality by improving disease detection. Trial completion date: Dec 2016 --> Dec 2019 | Trial primary completion date: Dec 2016 --> Dec 2019
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, buparlisib (AN2025) / Novartis, Adlai Nortye
Trial completion date, Trial primary completion date, Monotherapy, Metastases: PIK-ORL: Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive (clinicaltrials.gov) - Jul 10, 2018
P2, N=70, Recruiting,
Trial primary completion date: Dec 2017 --> Sep 2018 Trial completion date: Jan 2019 --> Apr 2020 | Trial primary completion date: Mar 2018 --> Apr 2019
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: CheckMate 651: Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - Jul 6, 2018
P3, N=930, Recruiting,
N=136 --> 252 N=700 --> 930 | Trial completion date: Dec 2020 --> Aug 2025 | Trial primary completion date: Feb 2019 --> Aug 2020
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion date, Trial primary completion date: A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors (clinicaltrials.gov) - Jul 5, 2018
P1, N=22, Recruiting,
N=700 --> 930 | Trial completion date: Dec 2020 --> Aug 2025 | Trial primary completion date: Feb 2019 --> Aug 2020 Trial completion date: Dec 2017 --> Jun 2019 | Trial primary completion date: Dec 2017 --> Dec 2018
- |||||||||| Bavencio (avelumab) / EMD Serono, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial initiation date, Combination therapy, Monotherapy, Metastases: EACH: Evaluating Avelumab in Combination With Cetuximab in Head and Neck Cancer (clinicaltrials.gov) - Jul 3, 2018
P2, N=130, Not yet recruiting,
Trial completion date: Dec 2017 --> Jun 2019 | Trial primary completion date: Dec 2017 --> Dec 2018 Initiation date: Apr 2018 --> Jul 2018
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion, Trial completion date, Combination therapy, Metastases: TAILOR: A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients (clinicaltrials.gov) - Jul 3, 2018
P3, N=553, Completed,
Initiation date: Apr 2018 --> Jul 2018 Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> Jan 2018
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, Metastases: NRG-HN004: Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin (clinicaltrials.gov) - Jun 25, 2018
P2/3, N=533, Suspended,
Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> Jan 2018 Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2025
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: SMAD4 loss is associated with cetuximab resistance and induction of MAPK/JNK activation in head and neck cancer cells. (Pubmed Central) - Jun 22, 2018
We show that SMAD4 depletion in a HNSCC cell line induces cetuximab resistance and results in worse survival in an orthotopic mouse model in vivo We implicate JNK and MAPK activation as mediators of cetuximab resistance and provide the foundation for the concomitant EGFR and JNK/MAPK inhibition as a potential strategy for overcoming cetuximab resistance in HNSCCs with SMAD4 loss. Our study demonstrates that loss of SMAD4 expression is a signature characterizing the cetuximab-resistant phenotype and suggests that SMAD4 expression may be a determinant of sensitivity/resistance to EGFR/MAPK or EGFR/JNK inhibition in HPV-negative HNSCC tumors.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
Trial completion date: S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride (clinicaltrials.gov) - Jun 21, 2018
P=N/A, N=140, Active, not recruiting,
Our study demonstrates that loss of SMAD4 expression is a signature characterizing the cetuximab-resistant phenotype and suggests that SMAD4 expression may be a determinant of sensitivity/resistance to EGFR/MAPK or EGFR/JNK inhibition in HPV-negative HNSCC tumors. Trial completion date: Apr 2018 --> Jul 2018
- |||||||||| monalizumab (IPH2201) / AstraZeneca, Innate, Imfinzi (durvalumab) / AstraZeneca
Trial primary completion date, IO biomarker, Metastases: A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors (clinicaltrials.gov) - Jun 8, 2018
P1, N=262, Recruiting,
Recruiting --> Suspended Trial primary completion date: Jan 2022 --> Feb 2020
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion, Surgery: S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer (clinicaltrials.gov) - Jun 3, 2018
P2, N=83, Completed,
Completed --> Terminated; Study terminated early 22Feb2010 with only 4 participants due to business reasons. Active, not recruiting --> Completed
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, Review, Journal: Optimising the use of cetuximab in the continuum of care for patients with metastatic colorectal cancer. (Pubmed Central) - May 17, 2018
Looking to the future, we propose that RAS status determination at disease progression by liquid, needle or excisional biopsy may identify patients eligible for cetuximab continuation and rechallenge. With this approach, treatment benefit can be extended, adding to established continuum-of-care strategies in patients with mCRC.
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