SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03656627

Developed by Shray Alag, 2019.
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 Multiple Sclerosis Ulcerative Colitis
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung Arthritis Sclerosis Arthritis, Rheumatoid Multiple Sclerosis Psoriasis Crohn Disease Colitis Ulcer Colitis, Ulcerative Lupus Erythematosus, Systemic Autoimmune Diseases Arteritis Giant Cell Arteritis Polymyalgia Rheumatica
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

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:
Arteritis
Arthritis
Genes 172
COL2A1 HJV COL3A1 IL10 RNASEH2B GDF5 IL12A RAG1 COL5A1 HGD IL12B RAG2 COL5A2 TREX1 DNAJB11 NLRP12 HNF1B COL9A1 TCF3 COL9A2 COL9A3 COL11A1 COL11A2 ATP7B RNF168 ZMPSTE24 UFSP2 ANK1 WAS COMP COMT WIPF1 MLX HLA-B RNASEH2A ERAP1 LEMD3 SLC26A2 HLA-DRB1 GJB6 MATN3 SPTA1 ACP5 SPTB SH3KBP1 TRPS1 PSMB4 BLNK PSMB9 GBA CASP10 PTPN22 IRF5 SAMHD1 EXT1 GCH1 EXT2 OCRL AIP CAV1 LBR PSTPIP1 APOE PFKM GPR101 RREB1 CFI FAS FASLG HNF4A ADAR ADA2 TF ANKRD55 ANKH F8 SLC40A1 KLRC4 F9 JMJD1C MEFV NLRC4 NLRP3 STAT3 STAT4 SLC4A1 HIRA KIF7 TFR2 NOD2 GHR PHEX TGFB3 CCN6 IFIH1 PTPN2 RASGRP1 GJB2 CD247 FBN1 IL36RN GLA SLC12A3 SEC24C LMNA CLCN7 CLCNKB HOXD10 AEBP1 ARVCF DCLRE1C CANT1 LACC1 MYH14 LMX1B MTHFD1 ASAH1 IL12A-AS1 AGA PIK3R1 ACAN HPGD SLCO2A1 HPRT1 IGHM SCARB2 BTK RNASEH2C UFD1 MIF TLR4 LRRC8A UMOD PRKCD CD79A TRPV4 CD79B CCR1 UBAC2 C4A CCN2 CCR6 FGFR3 IGLL1 GNAS LRBA TNFRSF1A MMP13 MUC1 IL2RA SEC61A1 PRG4 IL2RB EPCAM G6PC TNXB SLC37A4 DNASE1L3 ABCG5 IL6 ABCG8 IL23R TBX1 EPB42 MVK ZNF687 SMAD3 KIF22 GP1BB COL1A1 PRPS1 TRAPPC2
Autoimmunity
Genes 140
RNASEH2B KRAS TPP2 IL12A RAG1 RAG2 IL12RB1 TREX1 TCF4 GALC ITCH PRTN3 NRAS WAS COMT WIPF1 SPIB TNFSF12 RNASEH2A HLA-DPA1 GPR35 HLA-DPB1 HLA-DQB1 HLA-DRB1 POLG ACP5 KIAA0319L PEPD FADD AIRE TCIRG1 SRP54 OAS1 POU2AF1 CASP10 NBN NLRP1 PTPN22 IRF5 SAMHD1 TRAC CHD7 LMNB2 CAV1 LCK RREB1 SLC7A7 PTEN FAS ADA FASLG CR2 ADAR ADA2 RFX5 RFXAP ANKRD55 JMJD1C ZAP70 GFI1 STAT1 ITK STAT3 STAT4 HIRA TTC7A STIM1 IFNGR1 MST1 RMRP IFIH1 PTPN2 RASGRP1 LIG4 FCGR2C C1GALT1C1 CD3G KMT2D CD247 ICOS MMEL1 CSF2RA CSF2RB SLC12A3 SEC24C CD19 MS4A1 CLCNKB ARVCF CIITA DCLRE1C LACC1 MTHFD1 PIK3R1 RFXANK NFKB1 BTK NFKB2 RNASEH2C UFD1 MIF TNFRSF13C SERPING1 ELANE TNFRSF13B C1QA C1QB C1QC C1R C1S PRKCD C2 C3 CD81 C4A CCN2 CCR6 CTLA4 PLCG2 TNFAIP3 MMP2 C8A LRBA NHEJ1 IL2RA IL2RB IL2RG KDM6A TNFSF15 TNPO3 DNASE1L3 IL6 SEC23B TBX1 IL7R MASP2 GP1BB PNP TBX2 FOXP3
Colitis
Genes 34
TGFB1 IL10RA IL10RB MST1 XIAP CASP10 PRKCD RASGRP1 TCF4 NCF4 PLCG2 TNFAIP3 LRBA CARMIL2 GPIHBP1 FAS SKIV2L FASLG CIITA MAP3K7 RTEL1 RFX5 RFXAP GPR35 POLA1 ZAP70 RFXANK NLRC4 STAT1 OPLAH HPS1 MASP2 FERMT1 FOXP3
Crohn's disease
Genes 2
IGHM PSTPIP1
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1
Palmoplantar pustulosis
Polyarticular arthritis
Genes 13
IL2RA IL2RB PTPN2 ANKRD55 NLRP1 PTPN22 ENPP1 MEFV CD247 STAT4 TNFAIP3 DMP1 NOD2
Psoriasiform dermatitis
Genes 17
GATA3 TTC7A MSMO1 DSG1 FLI1 IRF2BP2 LIG4 HLA-DQB1 CACNA1G TP63 HLA-DRB1 SLC29A3 CTLA4 CARD14 NFKB2 IL36RN FOXP3
Rheumatoid arthritis
Genes 14
DCLRE1C IL2RA IL2RB LACC1 PTPN2 ANKRD55 PTPN22 IL6 GCH1 HLA-DRB1 ACP5 CD247 STAT4 MIF
Systemic lupus erythematosus
Genes 18
PEPD FAS FASLG SERPING1 TPP2 C1QA C1QB C1QC CASP10 C1S PRKCD C2 RASGRP1 C3 C4A DNASE1L3 C8A MASP2
Ulcerative colitis
Genes 6
MST1 MAP3K7 PLCG2 MASP2 GPR35 TCF4