Trial Outcomes & Findings for INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors. (NCT NCT03272464)

Last Updated: 2023-09-22

Results Overview

Maximum tolerated dose (MTD) is defined as the highest dose of the treatment that does not cause unacceptable side effects in at least two-thirds of participants.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

Approximately 2 months

Results posted on

2023-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Trametinib + Dabrafenib + INCB039110 * Dabrafenib is administered orally every 12 hours * Trametinib is administered orally once a day * INCB039110 is administered orally once a day Trametinib: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth. Dabrafenib: Dabrafenib may work by stopping your cancer cells from duplicating. INCB039110: Itacitinib may work by stopping your tumor cells from living and growing.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trametinib + Dabrafenib + INCB039110 n=1 Participants * Dabrafenib is administered orally every 12 hours * Trametinib is administered orally once a day * INCB039110 is administered orally once a day Trametinib: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth. Dabrafenib: Dabrafenib may work by stopping your cancer cells from duplicating. INCB039110: Itacitinib may work by stopping your tumor cells from living and growing.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 2 months

Population: Participant was on treatment for approximately 2 months, receiving starting dose (DL1) = 150mg DABRAFENIB twice daily by mouth + 2mg TRAMETINIB once daily by mouth + 200mg INCB039110 once daily.

Maximum tolerated dose (MTD) is defined as the highest dose of the treatment that does not cause unacceptable side effects in at least two-thirds of participants.

Outcome measures

Outcome measures
Measure	Trametinib + Dabrafenib + INCB039110 n=1 Participants * Dabrafenib is administered orally every 12 hours * Trametinib is administered orally once a day * INCB039110 is administered orally once a day Trametinib: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth. Dabrafenib: Dabrafenib may work by stopping your cancer cells from duplicating. INCB039110: Itacitinib may work by stopping your tumor cells from living and growing.
Maximum Tolerated Dose	NA milligrams Maximum tolerated dose was not reached due to an insufficient number of participants treated on the trial.

SECONDARY outcome

Timeframe: Approximately 7 months

Objective response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1 criteria as their best response to therapy.

Outcome measures

Outcome measures
Measure	Trametinib + Dabrafenib + INCB039110 n=1 Participants * Dabrafenib is administered orally every 12 hours * Trametinib is administered orally once a day * INCB039110 is administered orally once a day Trametinib: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth. Dabrafenib: Dabrafenib may work by stopping your cancer cells from duplicating. INCB039110: Itacitinib may work by stopping your tumor cells from living and growing.
Objective Response Rate	0 percentage of participants

SECONDARY outcome

Timeframe: 6 Months

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	Trametinib + Dabrafenib + INCB039110 n=1 Participants * Dabrafenib is administered orally every 12 hours * Trametinib is administered orally once a day * INCB039110 is administered orally once a day Trametinib: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth. Dabrafenib: Dabrafenib may work by stopping your cancer cells from duplicating. INCB039110: Itacitinib may work by stopping your tumor cells from living and growing.
Number of Participants With Progression-Free Survival at 6 Months	0 Participants

SECONDARY outcome

Timeframe: approximately 7 months

Overall Survival (OS) is defined as the time from the first treatment date to death due to any cause, or censored at date last known alive.

Outcome measures

Outcome measures
Measure	Trametinib + Dabrafenib + INCB039110 n=1 Participants * Dabrafenib is administered orally every 12 hours * Trametinib is administered orally once a day * INCB039110 is administered orally once a day Trametinib: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth. Dabrafenib: Dabrafenib may work by stopping your cancer cells from duplicating. INCB039110: Itacitinib may work by stopping your tumor cells from living and growing.
Overall Survival	212 days

Adverse Events

Trametinib + Dabrafenib + INCB039110

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Trametinib + Dabrafenib + INCB039110 n=1 participants at risk * Dabrafenib is administered orally every 12 hours * Trametinib is administered orally once a day * INCB039110 is administered orally once a day Trametinib: Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth. Dabrafenib: Dabrafenib may work by stopping your cancer cells from duplicating. INCB039110: Itacitinib may work by stopping your tumor cells from living and growing.
General disorders Fever	100.0% 1/1 • 7 months
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • 7 months
Gastrointestinal disorders Abdominal distension	100.0% 1/1 • 7 months
General disorders Edema limbs	100.0% 1/1 • 7 months
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • 7 months
Metabolism and nutrition disorders Hyponatremia	100.0% 1/1 • 7 months
Metabolism and nutrition disorders Hyperkalemia	100.0% 1/1 • 7 months
Investigations Aspartate aminotransferase increased	100.0% 1/1 • 7 months
Investigations Alkaline phosphatase increased	100.0% 1/1 • 7 months

Additional Information

David M. Miller, MD, PhD

Massachusetts General Hospital

Phone: 617-726-2667

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place