CMAB 819 (nivolumab biosimilar) / Mabpharm Limited - LARVOL DELTA

Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC (clinicaltrials.gov) - P1 | N=21 | Terminated | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | Trial completion date: Sep 2024 ➔ Oct 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: May 2024 ➔ Oct 2023; Difficult to recruit subjects

Metastases • Trial completion date • Trial primary completion date • Trial termination • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC (clinicaltrials.gov) - P1 | N=21 | Active, not recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | Recruiting ➔ Active, not recruiting | N=164 ➔ 21 | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: May 2022 ➔ May 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC (clinicaltrials.gov) - P1 | N=164 | Recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | Trial primary completion date: Sep 2022 ➔ May 2022

Metastases • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Combination active in HER2-expressing urothelial carcinoma (Healio) - "I think trastuzumab deruxtecan can play a potentially important role in the treatment armamentarium for patients with HER2-expressing urothelial cancers in the future,' Matthew D. Galsky, MD...'Earlier-generation HER2 antibody-drug conjugates did not show marked activity in urothelial cancer, so this emerging data is important and - along with other trials - are really validating HER2 as an important target in urothelial cancer.'"

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Testing Nivolumab and Ipilimumab With Short-Course Radiation in Advanced Rectal Cancer (clinicaltrials.gov) - P2; N=31; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor • MSI • PCR

’Unprecedented’ long-term survival after immunotherapy at CPNPC [Google translation] (Medscape) - "'These are unprecedented data,' Dr. Fred R. Hirsch, Ph.D...told Medscape Medical News. He did not participate in either study and was invited to comment. Global five-year survival rates more than doubled in the pembrolizumab groups compared to the docetaxel group,' reported Dr. Roy Herbst, Ph.D...He presented the new data at the recent World Conference on Lung Cancer (WCLC) 2020."

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Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC (clinicaltrials.gov) - P1; N=164; Recruiting; Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

Clinical • New P1 trial • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Immunotherapy Nivolumab Doubles Disease-Free Survival in a Type of High-Risk Urothelial Carcinoma (ASCO.org) - "'Even with the current standard of care - surgery with or without pre-surgery chemotherapy - muscle-invasive urothelial carcinoma has a high risk of recurring. These new findings show that treating patients at highest risk of recurrence with an immunotherapy after surgery can help extend the time until the disease returns,' said Robert Dreicer..."

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