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Report for Clinical Trial NCT03111901

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Low-dose Interleukin-2 and Pembrolizumab Among Patients With Metastatic Melanoma and Renal Cell Carcinoma

This study will evaluate the safety and disease control rate of the combination of pembrolizumab plus low-dose interleukin-2 in patients who have either advanced melanoma or renal cell cancer.

NCT03111901 Carcinoma, Renal Cell Melanoma
MeSH: Carcinoma Melanoma Carcinoma, Renal Cell
HPO: Carcinoma Clear cell renal cell carcinoma Cutaneous melanoma Melanoma Papillary renal cell carcinoma Renal cell carcinoma

2 Interventions

Name: Pembrolizumab

Description: Pembrolizumab solution

Type: Drug

Level -1 Level 1

Name: Interleukin-2

Description: Interleukin-2 solution

Type: Drug

Level -1 Level 1


Primary Outcomes

Description: Obtain preliminary data on the safety of LD-IL2 with pembrolizumab

Measure: Safety: adverse event profile

Time: up to 90 days post-treatment

Description: Estimate the disease control rate (CR+PR+SD by RECIST 1.1) among candidate patients with metastatic melanoma treated with pembrolizumab and LD-IL2 and to determine whether disease control is significantly improved. SD for 6 months or more will be considered SD for the purpose of this assessment.

Measure: Disease control rate: melanoma

Time: baseline and every 9 weeks (up to week 104)

Description: Estimate the disease control rate (CR+PR+SD by RECIST 1.1) among patients with metastatic renal cell cancer treated with pembrolizumab and LD-IL2 and to determine whether disease control is significantly improved. SD for 6 months or more will be considered SD for the purpose of this assessment.

Measure: Disease control rate: renal cell cancer

Time: baseline and every 9 weeks (up to week 104)

Secondary Outcomes

Description: Estimate progression-free survival defined as the duration of time from first response (SD/PR/CR) to time of recurrence/progression or death from any cause, whichever occurs first

Measure: Progression free survival: metastatic melanoma

Time: From first response (SD/PR/CR) to time of recurrence/progression or death from any cause, whichever occurs first, assessed for an estimated total of 120 months.

Description: Estimate progression-free survival defined as the duration of time from first response (SD/PR/CR) to time of recurrence/progression or death from any cause, whichever occurs first

Measure: Progression free survival: renal cell cancer

Time: From first response (SD/PR/CR) to time of recurrence/progression or death from any cause, whichever occurs first, assessed for an estimated total of 120 months.

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There are 3 SNPs

SNPs


1 V600E

If the melanoma expresses a BRAF mutation of V600E, V600K, or V600R patient must have received and progressed through a BRAF inhibitor or have failed that therapy due to toxicity. --- V600E ---


2 V600K

If the melanoma expresses a BRAF mutation of V600E, V600K, or V600R patient must have received and progressed through a BRAF inhibitor or have failed that therapy due to toxicity. --- V600E --- --- V600K ---


3 V600R

If the melanoma expresses a BRAF mutation of V600E, V600K, or V600R patient must have received and progressed through a BRAF inhibitor or have failed that therapy due to toxicity. --- V600E --- --- V600K --- --- V600R ---



HPO Nodes


HPO:
Carcinoma
Genes 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT
Clear cell renal cell carcinoma
Genes 1
NOD2
Cutaneous melanoma
Genes 15
HRAS MITF CDKN2A BRAF NRAS NRAS WRN CDKN2A CXCR4 BAP1 POLH CDK4 ERCC3 XPC MC1R
Melanoma
Genes 98
MGMT NRAS POT1 NRAS XPA CTSC BRCA1 SDHC ERCC4 CXCR4 RAD51C CDKN2B ERCC3 XPC PALLD ERCC2 ERCC2 CHEK2 CDKN2A RAD51D GNAQ SDHD KRAS MBTPS2 BAP1 BAP1 CYSLTR2 RNF43 BAP1 CDKN2A PTPN11 CDK4 BRCA2 ERCC3 MITF TERF2IP ERCC4 CHEK2 BRCA1 TRPV3 POT1 OCA2 TERT CDKN2A AKT1 CDKN2A SF3B1 ERCC6 ERCC5 ERCC5 MDM2 BRCA2 BAP1 GNA11 ACD BRIP1 HRAS MRE11 BRAF TYR TP53 KLLN SEC23B PTEN PIK3CA XPA PERP MITF RAF1 BRAF POLH TP53 BARD1 NRAS SMAD4 RAD50 DDB2 ERCC2 NBN TERT MC1R SLC45A2 WRN PALB2 DDB2 PALB2 CDKN2A SDHB MC1R RAD51 TP53 XPC ERCC3 PTEN CDKN2A POLH CDK4 MC1R
Papillary renal cell carcinoma
Genes 8
MET LMNA MINPP1 FOXE1 CDC73 FH HABP2 PRCC
Renal cell carcinoma
Genes 75
CCND1 TSC2 COL14A1 VHL HNF1B MET FLCN AKT1 SDHC HABP2 SDHAF2 NRAS FLCN SRC CDC73 FH APC PRCC SLC49A4 STK11 SDHB DCC TSC1 KLLN HNF1B SLC25A11 TP53 SDHD SEC23B BAP1 PTEN HNF1A KIF1B MAX PIK3CA VHL RNF139 MINPP1 CTNNB1 BUB1 RET KEAP1 DICER1 AAGAB DLC1 FN1 PIK3CA NOD2 SDHC FGFR3 FH TMEM127 VHL FLCN VHL OGG1 EP300 FOXE1 SDHB BUB1B AXIN2 SDHA MITF SDHD TFE3 FH IFNG PTPRJ LMNA HNF4A DLST MDH2 SDHB AKT1 FLCN