A Study of NIVO Plus IPI and Guadecitabine or NIVO Plus IPI in Melanoma and NSCLC Resistant to Anti-PD1/PDL1

Publication date: Jan 31, 2020

This is a run-in, randomized, non-comparative, phase II study designed according to a two stages optimal design by Simon. This phase II design will be preceded by a safety evaluation after the first cohort of 6 patients to preserve a high-grade of overlapping and/or unexpected toxicity rate. The study will assess the immune-objective response rate (iORR) (assessed using iRECIST criteria) of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab, in Melanoma and non-small cell lung cancer (NSCLC) patients resistant to anti-PD-1/PD-L1 therapy. Immune biologic correlates to treatment will be assessed as exploratory endpoints.

Concepts Keywords
Acute Toxicity Cancer therapies
ALK Tumor
ANC Therapeutic landscape melanoma
Biopsy Key hallmark cancer
Blockade Stage melanoma
Blood Anti cancer
BRAF NSCLC
Cancer Neoplastic cells tumor
Chemotherapy Cancer therapies
Clinical Translation Immunotherapy
Clinical Trials Immunotherapies
Cohort Chemotherapy
Creatinine Medicine
Cytologic Clinical medicine
DHA Cancer treatments
Epigenetic Immune system
Hemoglobin Antineoplastic drugs
Hypomethylating Agents Bristol-Myers Squibb
Immune Checkpoint Blockade Breakthrough therapy
Immunomodulatory Ipilimumab
Immunotherapies Checkpoint inhibitor
Immunotherapy Nivolumab
Ipilimumab Pembrolizumab
Italian Antibodies
Lung MRI
Lymphocytes Chemotherapy
M4
Malignant
Malignant Melanoma
Melanoma
Modality
Monoclonal Antibodies
MRI
Mutant
Mutation
Neoplastic
Optimal Design
Organ
PDL
PDL1
Platelets
Priming
Sequencing
Targeted Therapy
Toxicity
Translocation
Tumor
Vivo
WBC

Semantics

Type Source Name
disease MESH Tumor
drug DRUGBANK Creatinine
disease MESH biopsy
disease MESH diagnosis
pathway KEGG Non-small cell lung cancer
disease MESH non-small cell lung cancer
drug DRUGBANK Ipilimumab
drug DRUGBANK Nivolumab
pathway KEGG Melanoma
disease MESH Melanoma
drug DRUGBANK Guadecitabine

Original Article

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