Trial Outcomes & Findings for Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer (NCT NCT03428126)

NCT ID: NCT03428126

Last Updated: 2023-06-15

Results Overview

Best overall response rate (CR+PR) by immune-related response rate.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: From Baseline to 2 years
• Results posted on: 2023-06-15

Participant Flow

29 patients were enrolled to the first stage at The University of Texas MD Anderson Cancer Center.

Participant milestones

Measure	Durvalumab + Trametinib Single arm study. All participants received both study drugs
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer

Baseline characteristics by cohort

Measure	Durvalumab + Trametinib n=29 Participants Single arm study. All participants received both study drugs
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	2 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 2 years

Best overall response rate (CR+PR) by immune-related response rate.

Outcome measures

Measure	Durvalumab + Trametinib n=29 Participants Single arm study. All study participants received both study drugs.
Immune-related Best Overall Response Rate.	1 Participants

SECONDARY outcome

Timeframe: From Baseline to up to 2 years

The Kaplan-Meier method GraphPad software, V.8 was used for statistical analyses.

Outcome measures

Measure	Durvalumab + Trametinib n=29 Participants Single arm study. All study participants received both study drugs.
Progression Free Survival as Determined by irRC	3.2 months Interval 2.5 to 3.8

SECONDARY outcome

Timeframe: From Baseline to 2 years

The Kaplan-Meier method GraphPad software, V.8 was used for statistical analyses.

Outcome measures

Measure	Durvalumab + Trametinib n=29 Participants Single arm study. All study participants received both study drugs.
Overall Survival	6.9 months Interval 5.7 to 8.0

SECONDARY outcome

Timeframe: From Baseline to 2 years.

Disease control rate (DCR) describes the percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease.

Outcome measures

Measure	Durvalumab + Trametinib n=29 Participants Single arm study. All study participants received both study drugs.
Disease Control Rate Complete Response	0 percentage
Disease Control Rate Partial Response	3.4 percentage
Disease Control Rate Stable Disease	24 percentage

Adverse Events

Durvalumab + Trametinib

Serious events: 0 serious events

Other events: 29 other events

Deaths: 12 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Durvalumab + Trametinib n=29 participants at risk Single arm study. All participants received both study drugs.
General disorders Fatigue	31.0% 9/29 • from Baseline to 2 years
Gastrointestinal disorders Abdominal pain	6.9% 2/29 • from Baseline to 2 years
Gastrointestinal disorders Diarrhea	37.9% 11/29 • from Baseline to 2 years
Gastrointestinal disorders Nausea	24.1% 7/29 • from Baseline to 2 years
Skin and subcutaneous tissue disorders Rash	86.2% 25/29 • from Baseline to 2 years
Gastrointestinal disorders Anorexia	37.9% 11/29 • from Baseline to 2 years
Skin and subcutaneous tissue disorders Pruritus	10.3% 3/29 • from Baseline to 2 years
Respiratory, thoracic and mediastinal disorders Cough	17.2% 5/29 • from Baseline to 2 years
Investigations Alanine aminotransferase	24.1% 7/29 • from Baseline to 2 years
Investigations Bilirubin	6.9% 2/29 • from Baseline to 2 years
Investigations Aspartrate aminotransferase	31.0% 9/29 • from Baseline to 2 years
Investigations Alkaline phosphatase	37.9% 11/29 • from Baseline to 2 years
Investigations Anemia	41.4% 12/29 • from Baseline to 2 years
Investigations Thrombocytopenia	27.6% 8/29 • from Baseline to 2 years
Investigations Lipase	20.7% 6/29 • from Baseline to 2 years
Investigations Amylase	17.2% 5/29 • from Baseline to 2 years
Investigations Hypothyroidism	10.3% 3/29 • from Baseline to 2 years
Investigations Hyponatremia	13.8% 4/29 • from Baseline to 2 years

Additional Information

Dr. Michael Overman

MD Anderson Cancer Center

Phone: (713) 792-2828

Email: moverman@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place