Trial Outcomes & Findings for Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma (NCT NCT04310397)

Last Updated: 2024-10-30

Results Overview

To determine the 12-month relapse free survival (RFS) rate in stage IIIB/C/D melanoma patients who, after 8 weeks of neoadjuvant dabrafenib and trametinib, do not achieve a pCR and receive adjuvant dabrafenib, trametinib an spartalizumab.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Baseline up to 2 years

Results posted on

2024-10-30

Participant Flow

Patients with resectable stage IIIB/IIIC/IIID melanoma with BRAF V600E/K mutations. Only patients with V600E or V600K mutations are eligible for enrollment. Patients with BRAF by IHC is acceptable to for screening.

4 patients consented and treated.

Participant milestones

Participant milestones
Measure	Arm 1 Dabrafenib 150 mg PO BID D1-28 (starting dose); trametinib PO QD D1-28 (starting dose); Spartalizumab 400 mg IV over 30 minutes every 28 days
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Dabrafenib 150 mg PO BID D1-28 (starting dose); trametinib PO QD D1-28 (starting dose); Spartalizumab 400 mg IV over 30 minutes every 28 days
Overall Study Lack of Efficacy	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=4 Participants Dabrafenib 150 mg PO BID D1-28 (starting dose); trametinib PO QD D1-28 (starting dose); Spartalizumab 400 mg IV over 30 minutes every 28 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	4 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
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 2 years

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 2 years

Population: Data were not collected

To evaluate the sarety of neoadjuvant dabrafenib and trametini and adjuvant dabrafenib, trametinib ann spartalizumab

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline upto 2 years

Population: Data were not collected

To assess the recurrence patterns, distant metastasis-free survival (DMFS), and overall survival (OS) in all patients treated on protocol.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=4 participants at risk Dabrafenib 150 mg PO BID D1-28 (starting dose); trametinib PO QD D1-28 (starting dose); Spartalizumab 400 mg IV over 30 minutes every 28 days
General disorders Fever	25.0% 1/4 • Number of events 1 • Baseline up to 2 years
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • Baseline up to 2 years
Skin and subcutaneous tissue disorders Soft Tissue Infection	25.0% 1/4 • Number of events 1 • Baseline up to 2 years

Other adverse events

Other adverse events
Measure	Arm 1 n=4 participants at risk Dabrafenib 150 mg PO BID D1-28 (starting dose); trametinib PO QD D1-28 (starting dose); Spartalizumab 400 mg IV over 30 minutes every 28 days
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Number of events 1 • Baseline up to 2 years
Investigations Alanine aminotransfease increased	75.0% 3/4 • Number of events 8 • Baseline up to 2 years
Investigations Alkaline amionotransferase	75.0% 3/4 • Number of events 5 • Baseline up to 2 years
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	50.0% 2/4 • Number of events 3 • Baseline up to 2 years
Blood and lymphatic system disorders Anemia	75.0% 3/4 • Number of events 4 • Baseline up to 2 years
Psychiatric disorders Anxiety	75.0% 3/4 • Number of events 4 • Baseline up to 2 years
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 2/4 • Number of events 5 • Baseline up to 2 years
Investigations Aspartate aminotransferase increased	75.0% 3/4 • Number of events 6 • Baseline up to 2 years
Musculoskeletal and connective tissue disorders Back Pain	50.0% 2/4 • Number of events 2 • Baseline up to 2 years
Gastrointestinal disorders Bloating	25.0% 1/4 • Number of events 1 • Baseline up to 2 years
Blood and lymphatic system disorders Elevated WBC	50.0% 2/4 • Number of events 2 • Baseline up to 2 years
Blood and lymphatic system disorders Increased ANC	50.0% 2/4 • Number of events 2 • Baseline up to 2 years
Eye disorders Blurred Vision	25.0% 1/4 • Number of events 1 • Baseline up to 2 years
General disorders Chills	100.0% 4/4 • Number of events 16 • Baseline up to 2 years
Gastrointestinal disorders Constipation	75.0% 3/4 • Number of events 4 • Baseline up to 2 years
Investigations Creatinine Increased	50.0% 2/4 • Number of events 3 • Baseline up to 2 years

Additional Information

Rodabe Amaria, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 792-2921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place