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Report for Clinical Trial NCT03272464

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I Study of INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.

This research study is studying a combination of drugs as a possible treatment for BRAF-mutant melanoma. The drugs involved in this study are: - Itacitinib (INCB039110) - Dabrafenib - Trametinib

NCT03272464 Melanoma
MeSH: Melanoma
HPO: Cutaneous melanoma Melanoma

3 Interventions

Name: Trametinib

Description: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth.

Type: Drug

Trametinib + Dabrafenib + INCB039110

Name: Dabrafenib

Description: Dabrafenib may work by stopping your cancer cells from duplicating.

Type: Drug

Trametinib + Dabrafenib + INCB039110

Name: INCB039110

Description: Itacitinib may work by stopping your tumor cells from living and growing.

Type: Drug

Trametinib + Dabrafenib + INCB039110


Primary Outcomes

Description: Doses at which fewer than one third of patients have severe toxicity

Measure: Maximum Tolerated Dose

Time: 2 years

Secondary Outcomes

Description: Proportion of patients with tumor shrinkage that meets standard criteria for response

Measure: Objective Response Rate

Time: 2 years

Description: Time until worsening of cancer

Measure: Progression Free Survival

Time: 6 Months

Description: Time until death from cancer

Measure: Overall Survival

Time: 1 year

Description: Proportion of patients with complete tumor shrinkage

Measure: Complete response rate

Time: 2 years

Description: Proportion of patients with less than complete tumor shrinkage

Measure: Partial Response Rate

Time: 2 years

Description: Proportion of patients with no change in tumor size

Measure: Stable Disease

Time: 2 years

Description: Proportion of patients with worsening of cancer at or before first response assessment

Measure: Progressive Disease

Time: 2 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V600E

Inclusion Criteria: - For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy or not previously received BRAF targeted therapy, and for which standard curative or palliative measures do not exist or are no longer effective. --- V600E ---

- For Dose-Expansion Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy at full dose or not previously received BRAF targeted therapy. --- V600E ---

Current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded Inclusion Criteria: - For Dose-Escalation Phase: Patients must have histologically confirmed, BRAF-mutant (V600E/K) malignancy (molecularly confirmed using Cobas assay or a comparable FDA-approved assay (for exceptions, see below*) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy or not previously received BRAF targeted therapy, and for which standard curative or palliative measures do not exist or are no longer effective. --- V600E ---



HPO Nodes


HPO:
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