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Report for Clinical Trial NCT04061980

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Encorafenib/Binimetinib With or Without Nivolumab for Patients With Metastatic BRAF V600 Mutant Thyroid Cancer

This phase II trial studies how well encorafenib and binimetinib given with or without nivolumab works in treating patients with BRAF V600 mutation positive thyroid cancer that has spread to other places in the body (metastatic) and does not respond to radioiodine treatment (refractory). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The trial aims to find out if the combination of encorafenib and binimetinib, with and without study nivolumab, is a safe and effective way to treat metastatic radioiodine refractory thyroid cancer.

NCT04061980 BRAF NP_004324.2:p.V600M BRAF V600E Mutation Present Metastatic Thyroid Gland Carcinoma Refractory Thyroid Gland Carcinoma Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8 Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8 Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8
MeSH:Carcinoma Thyroid Neoplasms Thyroid Diseases
HPO:Abnormality of the thyroid gland Carcinoma Neoplasm of the thyroid gland Thyroid adenoma Thyroid carcinoma Thyroid follicular adenoma

3 Interventions

Name: Binimetinib

Description: Given PO
Type: Drug
Group Labels: 2

Arm I (encorafenib, binimetinib) Arm II (encorafenib, binimetinib, nivolumab)

Name: Encorafenib

Description: Given PO
Type: Drug
Group Labels: 2

Arm I (encorafenib, binimetinib) Arm II (encorafenib, binimetinib, nivolumab)

Name: Nivolumab

Description: Given IV
Type: Biological
Group Labels: 1

Arm II (encorafenib, binimetinib, nivolumab)


Primary Outcomes

Description: ORR is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria. ORR at 6 months will be assessed using the efficacy evaluable analysis set. A point and 90% exact binomial confidence interval will be provided for each arm.

Measure: Overall response rate (ORR)

Time: From the start of randomization up to 6 months from first dose of study drugs

Secondary Outcomes

Description: The Kaplan-Meier method will be used to estimate PFS and the summary statistics (e.g., 12-month survival, median survival, 95% confidence intervals) will be provided for each arm.

Measure: Progression free survival (PFS)

Time: From date of randomization until either tumor progression (per RECIST v1.1) or death, assessed for up to 12 months

Description: The Kaplan-Meier method will be used to estimate OS and the summary statistics (e.g., 12-month survival, median survival, 95% confidence intervals) will be provided for each arm.

Measure: Overall survival

Time: From date of randomization until the date of death from any cause, assessed for up to 1 year

Description: The Kaplan-Meier method will be used to estimate DOR, and the summary statistics (e.g., 12-month survival, median survival, 95% confidence intervals) will be provided for each arm. DOR will be estimated only among responders (i.e. participants achieving at least once CR or PR). Data visualization tools such as waterfall plots (% change in tumor size) or swimmer plot (DOR) will be used to display the data.

Measure: Duration of response (DOR)

Time: From date of first documented CR or PR up to first documented progression or death due to any cause, assessed for up to 1 year

Description: Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Using the safety evaluable analysis set, the incidence of having grade >= 3 adverse events will be determined for study participants that received at least one dose of their assigned treatment. The point estimate and 95% confidence interval will be reported for each arm.

Measure: Incidence of grade >= 3 toxicities

Time: From the first dose of assigned study intervention until 90 days from the last dose of assigned study intervention

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

ability to understand the patient information, give informed consent, comply with the study protocol or complete the study BRAF NP_004324.2:p.V600M BRAF V600E Mutation Present Metastatic Thyroid Gland Carcinoma Refractory Thyroid Gland Carcinoma Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8 Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8 Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8 Carcinoma Thyroid Neoplasms Thyroid Diseases PRIMARY OBJECTIVES: I. To assess the overall rate of response among study participants treated with the combination of encorafenib and binimetinib, with or without nivolumab. --- V600E ---



HPO Nodes


HPO:
HP:0000820: Abnormality of the thyroid gland
Genes 475
SRD5A3 IYD IL2RG GABRA3 ATRX PAX8 IDH2 DMXL2 DUOX2 TNFSF15 GATA1 TCF4 KCNJ10 TWNK RRM2B TTC37 DCLRE1C MC2R ALX4 EXT2 PLCG2 SDHD XRCC4 GABRD FASLG TRNL1 BCL10 BUB1 NKX2-1 TSHR CHD7 FOXP3 FMR1 TSHB LHX4 SETBP1 PDE4D MST1 MALT1 MSTO1 SLC26A4 AIP CDH23 RPS20 GLIS3 BMPR1A SUFU TRNN GNAS TRNL2 PDE4D SUFU FOXP1 TBX1 PIEZO1 ND1 NRAS HBB CLCNKB COX2 EDN3 ZFAT EYA1 GCH1 EIF2AK3 EFEMP2 GLI2 TRAPPC9 PTEN PAX8 SEMA4A HABP2 UFD1 FGF8 PAX8 RNASEH2A LRBA TDGF1 B3GLCT FOXE1 LHX3 TG RET RMRP HRAS TSHR CTNS CASR NKX2-1 TRNQ HSD17B3 EDNRB CDKN2B JMJD1C SGPL1 NKX2-1 PROP1 IFNG THRB FLCN SLC5A5 THRB MLH1 POLG TSHR KCNJ18 KDM6A FUT8 CDKN1A CCBE1 IL12A LIG4 HLA-DRB1 FBLN5 TRNS1 ALMS1 DCLRE1C FOXE1 MSH3 TMEM67 CTNNB1 PAX8 TG POLG2 SEC24C SEMA3E SDHC ZIC2 TNPO3 SLC25A4 LEPR TSHR MMP2 USP9X FOXE1 LEP BIRC3 SDHB WDR4 GDNF LMNA CDKN1B LHX3 TRNL1 TBCK NNT THRA FOXI1 NNT COMT ACP5 POU1F1 SOX3 STAT1 PROKR2 GNAS VPS13A SEMA3D SOX3 TGFBR2 APC LIFR MINPP1 DISP1 CTNS THRB PROP1 SUGCT WDR11 DDOST COX1 TSHR ELN TBX1 PTEN LIG4 TXNRD2 ND5 SIX3 RAG1 ND4 TREX1 SEC23B TSHB CDKN1B RAI1 ADAT3 ELN TPO CEP57 USF3 FOXA2 RREB1 BUB3 SRY IGSF1 PDGFB CDC73 DUOXA2 DEAF1 BCOR FOXI1 PROP1 KLLN HSD17B3 KAT6B FOXP3 NSDHL DLL1 MMP14 WRN GP1BB GLI3 CEP57 BMP4 RFC2 NRTN SRGAP1 CACNA1S KISS1R PPP1R15B STAT3 ND6 CDKN2C TSHR TANGO2 HESX1 RET GPC1 STUB1 HNF1B AKT1 DICER1 TRNF NODAL SLC26A4 DNAJC19 PMM2 DICER1 CTLA4 PRDM16 ITCH GLI2 GNE SKI POLR1D KCNAB2 INSR SLC12A3 ENPP1 WFS1 GLI3 LIMK1 MRAP PTEN TBL2 RNASEH2B TWNK TGIF1 NKX2-5 ZBTB20 POMC TSHR PTEN YY1 DNM1L RERE NKX2-5 MARS1 SCN4A MSH3 ABCC6 IL7R GATA6 GREM1 PRKAR1A ADAMTSL1 POU3F4 EXOSC2 SLC6A17 LEPR KEAP1 CHD7 FUCA1 WFS1 APC IFIH1 HIRA RAI1 AFF4 PIK3C2A RBM28 FGFR1 ARNT2 KMT2D POU2AF1 SMARCB1 CLIP2 SEC23B CACNA1S ALG8 CP MEN1 TPO PPP1R15B PLVAP FAS SIX1 GNAS FANCI BUB1B RET DACT1 HABP2 C1QBP PTRH2 ADAR GAS1 ADA STAT1 SHH STAR IL12RB1 IRF5 FOXH1 TBC1D24 BMPR1A MINPP1 TRHR NKX2-5 POLR1C TRH DNAH1 PMS1 NKX2-1 PIK3CA RAG2 PCSK1 FDX2 GNAS FOXE1 MSTO1 RAI1 MSH6 TF TBX2 FLII FOXE1 TONSL APC STEAP3 BRAF PIK3CA SKIV2L TG HPD POLG LHX4 PROP1 PIK3CA EPCAM FOXD3 TRNS1 KCNJ18 MEN1 IQSEC2 SAA1 KRAS SLC5A5 KAT6B DUOX2 TRIP13 UBR1 SLC26A4 TSC2 IGH AKT1 USP9X ALMS1 PMS2 RCBTB1 APC HBB RASGRP1 CASP10 ROBO1 POU1F1 NPHS1 DMXL2 CDC73 ARVCF GTF2I DUOXA2 TRNW COX3 LHX4 POLR3A PLAA IL2RA CDON PRKAR1A HNF4A RNASEH2C JAG1 BTNL2 TRNH OPA1 DICER1 KIAA0556 NLRP1 TCOF1 APOE GPR35 TBX1 SLC16A2 PRKCD AIRE KCNJ10 HESX1 TRNS2 MLXIPL SAMHD1 TRMT10A LIG4 SEMA3C FMR1 CDH23 TANGO2 TSHR FLCN PTCH1 HESX1 BAZ1B FAN1 CDC73 POU1F1 GPR161 C1S IYD PHF21A MEN1 IDH1 LRP4 DUOX2 RET APC CACNA1C SASH1 PTEN TTC7A OTX2 MSH2 ECE1 APC TRNW MMEL1 SALL1 MCM8 XRCC4 DCAF17 FAS MLH3 SALL1 FOXP1 SPIB NF2 CLPB CDON LHX4 NIN ARL6IP6 GTF2IRD1 SLC26A4 TSC1 PRKAR1A
Protein Mutations 4
F11N K601E V600E V600K
SNP 0