INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03272464|
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : June 13, 2019
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)
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Trametinib Drug: Dabrafenib Drug: INCB039110||Phase 1|
This research study is a Phase I clinical trial, which tests the safety of the investigational drugs and also tries to define the appropriate doses of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved itacitinib as a treatment for any disease.
The FDA has approved dabrafenib and trametinib as a treatment option for Melanoma.
In this research study, the investigators are studying the combination of itacitinib, dabrafenib, and trametinib. The investigators believe this combination of study drugs may stop the participant's cancer cells from growing and spreading. All three of the study drugs are inhibitors. Trametinib may work by binding to the participant's cancer cells to inhibit the cancer cells' signals to decrease cell growth, dabrafenib may work by stopping the participant's cancer cells from duplicating, and itacitinib may work by stopping the participant's tumor cells from living and growing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.|
|Actual Study Start Date :||May 29, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: Trametinib + Dabrafenib + INCB039110
Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth.
Other Name: Mekinist
Dabrafenib may work by stopping your cancer cells from duplicating.
Other Name: Tafinlar
Itacitinib may work by stopping your tumor cells from living and growing.
Other Name: Itacitinib
- Maximum Tolerated Dose [ Time Frame: 2 years ]Doses at which fewer than one third of patients have severe toxicity
- Objective Response Rate [ Time Frame: 2 years ]Proportion of patients with tumor shrinkage that meets standard criteria for response
- Progression Free Survival [ Time Frame: 6 Months ]Time until worsening of cancer
- Overall Survival [ Time Frame: 1 year ]Time until death from cancer
- Complete response rate [ Time Frame: 2 years ]Proportion of patients with complete tumor shrinkage
- Partial Response Rate [ Time Frame: 2 years ]Proportion of patients with less than complete tumor shrinkage
- Stable Disease [ Time Frame: 2 years ]Proportion of patients with no change in tumor size
- Progressive Disease [ Time Frame: 2 years ]Proportion of patients with worsening of cancer at or before first response assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272464
|Contact: Keith Flaherty, MD||617-724-4800||KFLAHERTY@mgh.harvard.edu|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02214|
|Contact: Keith Flaherty, MD 617-724-4800 KFLAHERTY@mgh.harvard.edu|
|Principal Investigator: Keith T. Flaherty, MD|
|Principal Investigator:||Keith T. Flaherty, MD||Massachusetts General Hospital|