Trial Outcomes & Findings for Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma (NCT NCT03149029)

Last Updated: 2025-12-05

Results Overview

The rate of clinical benefit is defined as the percentage of patients with stable disease, partial response, or complete response 6 months after the start of treatment per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) while remaining off MAPK-targeted therapy after induction. Response to treatment was assessed using radiographic imaging. A partial response (PR) is defined as a decrease in the sum of the longest diameters (SLD) of target lesions greater than or equal to 30%, no new lesions, and no progression of non-target lesions. A complete response (CR) is defined as the disappearance of all lesions and pathologic lymph nodes. Stable disease is defined as no PR, CR, or progressive disease (PD). PD is defined as an increase in the SLD of target lesions greater than or equal to 20% in comparison with the smallest SLD on study, progression of non-target lesions, or the appearance of new lesions.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

6 months

Results posted on

2025-12-05

Participant Flow

Only 5/14 BRAFV600 mutant patients had clinical benefit and the threshold for opening the BRAFV600 wild type cohort was 9/14 patients. Therefore, no BRAFV600 wild type patients were enrolled.

Participant milestones

Participant milestones
Measure	BRAFV600 mutant * Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Dabrafenib: Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	BRAFV600 wild type * Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth
Overall Study STARTED	16	0
Overall Study COMPLETED	14	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BRAFV600 mutant * Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Dabrafenib: Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	BRAFV600 wild type * Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth
Overall Study Adverse Event	2	0

Baseline Characteristics

Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BRAFV600 Mutant n=14 Participants * Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Dabrafenib: Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	BRAFV600 Wild Type * Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	Total n=14 Participants Total of all reporting groups
Age, Continuous	58.6 years STANDARD_DEVIATION 12.4 • n=37 Participants	—	58.6 years STANDARD_DEVIATION 12.4 • n=74 Participants
Sex: Female, Male Female	3 Participants n=37 Participants	—	3 Participants n=74 Participants
Sex: Female, Male Male	11 Participants n=37 Participants	—	11 Participants n=74 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	—	0 Participants n=74 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	—	0 Participants n=74 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	—	0 Participants n=74 Participants
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants	—	0 Participants n=74 Participants
Race (NIH/OMB) White	14 Participants n=37 Participants	—	14 Participants n=74 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	—	0 Participants n=74 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	—	0 Participants n=74 Participants

PRIMARY outcome

Timeframe: 6 months

Population: No BRAFV600 wild type patients were enrolled.

Outcome measures

Outcome measures
Measure	BRAFV600 mutant n=14 Participants * Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Dabrafenib: Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	BRAFV600 wild type * Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth
The Rate of Clinical Benefit	5 Participants	—

SECONDARY outcome

Timeframe: 1 year

Population: No BRAFV600 wild type subjects were enrolled. 2 participants of the original 16 were excluded from the analysis because they didn't receive pembrolizumab, and survival data was not available for 2 additional subjects.

Overall survival is the time between the first dose of targeted therapy and death from any cause. Overall survival at 1 year is defined as the proportion of participants who were alive one year after starting treatment. For patients who were lost to follow-up or who had no documentation of death at the time of final analysis, follow-up was censored at the date of last assessment of vital status. Confidence intervals are based on log (-log(endpoint)) methodology.

Outcome measures

Outcome measures
Measure	BRAFV600 mutant n=12 Participants * Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Dabrafenib: Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	BRAFV600 wild type * Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth
Overall Survival at 1 Year	0.656 proportion of participants Interval 0.233 to 0.885	—

SECONDARY outcome

Timeframe: Up to 62 months

Population: No BRAFV600 wild type subjects were enrolled. 2 of the original 16 subjects were excluded from the analysis since they didn't receive pembrolizumab, and progression data was not available for one additional subject.

PFS is defined as the time from the start of study treatment until progressive disease (PD) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria or death due to any cause. Participants alive without disease progression are censored at the the date of last disease evaluation. PD is defined as an increase in the SLD of target lesions greater than or equal to 20% in comparison with the smallest SLD on study, progression of non-target lesions, or the appearance of new lesions. Confidence intervals are based on log (-log(endpoint)) methodology.

Outcome measures

Outcome measures
Measure	BRAFV600 mutant n=13 Participants * Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Dabrafenib: Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	BRAFV600 wild type * Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth
Progression Free Survival (PFS)	4.73 months Interval 3.48 to 6.8	—

Adverse Events

BRAFV600 mutant (Dabrafenib, Trametinib, and Pembrolizumab)

Serious events: 6 serious events

Other events: 13 other events

Deaths: 2 deaths

BRAFV600 wild type

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BRAFV600 mutant (Dabrafenib and Trametinib ONLY)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BRAFV600 mutant (Dabrafenib, Trametinib, and Pembrolizumab) n=14 participants at risk * Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Dabrafenib: Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	BRAFV600 wild type * Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally Pembrolizumab: Pembrolizumab is a type of antibody that inhibits the cancer cell growth Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth	BRAFV600 mutant (Dabrafenib and Trametinib ONLY) n=2 participants at risk * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally Subjects were enrolled to the BRAFV600 mutant arm but did NOT receive pembrolizumab due to toxicity from Dabrafenib/Trametinib and discontinued from the study early. They were therefore excluded from analysis for the primary and secondary outcome measures, but adverse event data is available for these patients. Dabrafenib: Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating Trametinib: Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth
Nervous system disorders Syncope	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Vascular disorders Hypotension	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Infections and infestations Sepsis	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Renal and urinary disorders Acute kidney injury	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Renal and urinary disorders Chronic Kidney Disease	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Skin and subcutaneous tissue disorders Rash macro-papular	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
General disorders Fever	14.3% 2/14 • Number of events 4 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Gastrointestinal disorders Abdominal Pain	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
General disorders Fatigue	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Investigations Aspartate Aminotransferase Increased	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.
Investigations Alanine Aminotransferase Increased	7.1% 1/14 • Number of events 1 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	— 0/0 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.	0.00% 0/2 • AEs collected up to 2 years, 5 months (from first dose of study treatment until 90 days after the last dose of study treatment.) All cause mortality was assessed up to 62 months. In addition to the clinicaltrials.gov definitions, (1) Pyrexia accompanied by hypotension, dehydration, renal insufficiency and/or severe (grade 3+) rigors/chills in the absence of an obvious infectious cause, (2) Occurrence of Cutaneous squamous cell carcinoma (SCC), and (3) Central serous retinopathy (CSR) and Retinal Vein Occlusion (RVO) are also considered serious adverse events.

Other adverse events

Additional Information

Ryan J. Sullivan, MD

Massachusetts General Hospital Cancer Center

Phone: 617-643-3614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place