Trial Outcomes & Findings for M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability (NCT NCT03436563)

NCT ID: NCT03436563

Last Updated: 2024-11-27

Results Overview

Defined as the percentage of somatic mutations, ctDNA that is eliminated in blood as well as no appearance of any new somatic mutations following six doses of BA in the study participants.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: Baseline up to 12 weeks
• Results posted on: 2024-11-27

Participant Flow

Prospective, single-arm pilot study of BA as monotherapy conducted under Institutional Review Board approval at The University of Texas MD Anderson Cancer Center (Houston, TX).

Participant milestones

Measure	IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg 6 planned doses until one of the following events (whichever came first): therapeutic failure requiring urgent additional antineoplastic therapy, unacceptable toxicity, onset of pregnancy, or withdrawal of informed consent. Followed by evaluation for treatment response with repeat ctDNA analysis.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability

Baseline characteristics by cohort

Measure	IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg n=4 Participants 6 planned doses until one of the following events (whichever came first): therapeutic failure requiring urgent additional antineoplastic therapy, unacceptable toxicity, onset of pregnancy, or withdrawal of informed consent. Followed by evaluation for treatment response with repeat ctDNA analysis.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	55.9 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 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 12 weeks

Defined as the percentage of somatic mutations, ctDNA that is eliminated in blood as well as no appearance of any new somatic mutations following six doses of BA in the study participants.

Outcome measures

Measure	IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg n=4 Participants 6 planned doses until one of the following events (whichever came first): therapeutic failure requiring urgent additional antineoplastic therapy, unacceptable toxicity, onset of pregnancy, or withdrawal of informed consent. Followed by evaluation for treatment response with repeat ctDNA analysis.
Percentage of Circulating DNA Clearance	0 percentage of DNA cleared Interval 0.0 to 60.0

SECONDARY outcome

Timeframe: Baseline up to 2 years

Number of participants alive from baseline through 2 years

Outcome measures

Measure	IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg n=4 Participants 6 planned doses until one of the following events (whichever came first): therapeutic failure requiring urgent additional antineoplastic therapy, unacceptable toxicity, onset of pregnancy, or withdrawal of informed consent. Followed by evaluation for treatment response with repeat ctDNA analysis.
Overall Survival (OS)	4 Participants

SECONDARY outcome

Timeframe: Start of study treatment up to 28 days after end of treatment

The occurrence of grade 3 or higher adverse events according to CTCAE version 4.03

Outcome measures

Measure	IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg n=4 Participants 6 planned doses until one of the following events (whichever came first): therapeutic failure requiring urgent additional antineoplastic therapy, unacceptable toxicity, onset of pregnancy, or withdrawal of informed consent. Followed by evaluation for treatment response with repeat ctDNA analysis.
Grade 3 or Higher A/E Per CTCAE v4.03	0 number of events

SECONDARY outcome

Timeframe: Baseline up to 2 years

The time from the date of first administration of BA until the date of documented recurrence or development of distant metastasis by RECIST.

Outcome measures

Measure	IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg n=4 Participants 6 planned doses until one of the following events (whichever came first): therapeutic failure requiring urgent additional antineoplastic therapy, unacceptable toxicity, onset of pregnancy, or withdrawal of informed consent. Followed by evaluation for treatment response with repeat ctDNA analysis.
Disease-Free Survival (DFS)	3 Months Interval 0.9 to 27.0

Adverse Events

IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg n=4 participants at risk 6 planned doses until one of the following events (whichever came first): therapeutic failure requiring urgent additional antineoplastic therapy, unacceptable toxicity, onset of pregnancy, or withdrawal of informed consent. Followed by evaluation for treatment response with repeat ctDNA analysis.
Skin and subcutaneous tissue disorders Rash	75.0% 3/4 • 3 years
Skin and subcutaneous tissue disorders Squamous Cell Ca of the Skin	25.0% 1/4 • 3 years
Skin and subcutaneous tissue disorders Actinic Keratosis	25.0% 1/4 • 3 years
Gastrointestinal disorders Anorexia	25.0% 1/4 • 3 years
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • 3 years
Skin and subcutaneous tissue disorders Condyloma	25.0% 1/4 • 3 years
Respiratory, thoracic and mediastinal disorders Nasal Congestion	25.0% 1/4 • 3 years
Investigations Creatinine Kinase Increased	25.0% 1/4 • 3 years
Gastrointestinal disorders Diarrhea	25.0% 1/4 • 3 years
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • 3 years
General disorders Fatigue	25.0% 1/4 • 3 years
General disorders Flu-Like Symptoms	25.0% 1/4 • 3 years
Endocrine disorders Hypothyroidism	25.0% 1/4 • 3 years
Gastrointestinal disorders Mucositis	25.0% 1/4 • 3 years
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • 3 years

Additional Information

Dr. Van Morris

M D Anderson Cancer Center

Phone: 713-792-2828

Email: vkmorris@mdanderson.org

Results disclosure agreements

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