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Report for Clinical Trial NCT03656627

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type. Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.

NCT03656627 Autoimmune Diseases Non-small Cell Lung Cancer Rheumatoid Arthritis Psoriasis Giant Cell Arteritis Polymyalgia Rheumatica Systemic Lupus Erythematosus Crohn Disease Mu Multiple Sclerosis Ulcerative Colitis
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Arthritis Arthritis, Rheumatoid Polymyalgia Rheumatica Crohn Disease Colitis Colitis, Ulcerative Multiple Sclerosis Giant Cell Arteritis Arteritis Psoriasis Lupus Erythematosus, Systemic Autoimmune Diseases Sclerosis
HPO:Arteritis Arthritis Autoimmunity Colitis Crohn's disease Neoplasm of the lung Non-small cell lung carcinoma Palmoplantar pustulosis Polyarticular arthritis Psoriasiform dermatitis Rheumatoid arthritis Systemic lupus erythematosus Ulcerative colitis

1 Interventions

Name: Nivolumab

Description: Nivolumab will be given as an IV infusion every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level.
Type: Drug
Group Labels: 2

Nivolumab: Autoimmune Diseases Cohort 1 Nivolumab: Autoimmune Diseases Cohort 2


Primary Outcomes

Description: The DLT determination period is the first six weeks after cycle 1 day 1. Dose limiting toxicities are further defined in the trial protocol.

Measure: Dose-Limiting Toxicity (DLT)

Time: 48 Months

Secondary Outcomes

Description: Overall response rate is defined to be the best objective status recorded from the start of the treatment until disease progression/recurrence

Measure: Overall Response Rate

Time: 48 Months

Description: Progression-free survival will be evaluated for each cohort using Kaplan-Meier estimator.

Measure: Progression-Free Survival

Time: 48 Months

Description: Overall survival will be evaluated for each cohort using Kaplan-Meier estimator.

Measure: Overall Survival

Time: 48 Months

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

4. Patients should have received at least one platinum-based chemotherapy regimen for recurrent or metastatic disease or have received platinum-based chemotherapy as part of adjuvant or neoadjuvant therapy and experienced progression of disease within 6 months of completing therapy. 5. Patients with tumor genetic alterations such as EGFR, ALK, ROS1 or BRAF V600E alterations for which there is FDA-approved targeted therapy must have been treated with the appropriate targeted inhibitors in prior therapy 6. --- V600E ---



HPO Nodes


HPO:
Protein Mutations 1
V600E
SNP 0
HP:0001369: Arthritis
Genes 263
MEFV COL2A1 NLRP3 COL1A1 COL5A1 HLA-DRB1 STAT4 MLX GPR101 IL2RA CLCN7 IL10 KLRC4 SCARB2 NOD2 MUC1 PTPN22 FGFR3 ABCG8 IL12A COPA FASLG SLC12A3 LRRC8A MATN3 COMP OCRL LACC1 IRAK1 RNASEH2B SLC37A4 ZMPSTE24 SPTB MMP13 IL12A-AS1 AGA PSTPIP1 ERAP1 SH3KBP1 TRPV4 CD79B LBR SMAD3 SPTA1 DNASE1L3 HLA-C UFSP2 TGFB3 TBX1 COL2A1 ANKH EPCAM COL2A1 NLRP3 ATP7B PTPN22 IFIH1 CLCNKB MTHFD1 HIRA SLC40A1 MVK TRPS1 GCH1 ANK1 HOXD10 UFD1 COL2A1 CD79A COL11A2 RNASEH2A HPRT1 LRBA FRZB SLC22A4 HGD BLNK PSMB9 GDF5 TCF3 KIF7 GHR HGD CCN6 FAS HLA-B LMNA ACAN CIITA JMJD1C ACAN TRAPPC2 PRG4 ADAR FCGR2A UMOD GNAS KIF22 HPRT1 AEBP1 CD244 CFI MEFV C4A COL9A2 CAV1 IL2RA UBAC2 PTPN22 FCGR2B NLRP3 RAG1 CD247 MATN3 IL23R DCLRE1C LRP6 COL9A3 LMX1B COL11A2 HLA-B SEC24C CLCN7 ADA2 BTK C1R GBA TF MMP13 ANKH PHEX COL2A1 SEC61A1 COL9A2 HLA-DRB1 SLC4A1 SLCO2A1 UFSP2 HNF1B F9 PIK3R1 GLA MMP2 COL3A1 COMP CTLA4 TLR4 COL9A3 COL1A1 ASAH1 STAT4 COL9A1 HPRT1 IL10 GJB6 CD247 COL5A2 CANT1 IL2RB BTK LEMD3 RASGRP1 CASP10 AIP ASPN COMT ACP5 FBN1 SLC26A2 MVK COMP STAT4 ARVCF WAS EPB42 NLRP12 UMOD CCN6 ZNF687 PFKM PTPN2 SLC37A4 PTPN22 TNFRSF1A HNF4A RNASEH2C TFR2 COL5A1 TREX1 COMP PSMB4 DNASE1 DNAJB11 EXT1 NOD2 BTK APOE NLRC4 TRPV4 TBX1 PRKCD COL2A1 F8 TREX1 COL2A1 MYH14 PRPS1 SMAD3 IL36RN HPGD ANKRD55 C1QA SAMHD1 COL11A2 MATN3 EXT2 PHEX RREB1 CCR6 RAG2 ANKRD55 CCN2 HJV MEFV IL12B IRF5 FAS CCR1 COL11A1 STAT4 NFKBIL1 PSTPIP1 COL9A1 TRAPPC2 ACAN G6PC HLA-DRB1 COL2A1 SPP1 IL2RB MMP14 HPGD PADI4 GP1BB RNF168 PTPN22 COL2A1 WIPF1 NLRP3 HPRT1 PTPN2 IGHM FAS GJB2 HPGD STAT3 IGLL1 MEFV IL6 ATP7B HNF1B HLA-B MIF
Protein Mutations 4
A147T N363S R620W V600E
Protein Mutations 0
SNP 0