Trial Outcomes & Findings for Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer (NCT NCT02227667)
NCT ID: NCT02227667
Last Updated: 2021-06-18
Results Overview
according to RECIST 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
2 years
Results posted on
2021-06-18
Participant Flow
Participant milestones
| Measure |
Patients With Advanced Colorectal Cancer
This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.
MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Patients With Advanced Colorectal Cancer
n=16 Participants
This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.
MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 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
|
2 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
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsaccording to RECIST 1.1.
Outcome measures
| Measure |
Patients With Advanced Colorectal Cancer
n=16 Participants
This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.
MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.
|
|---|---|
|
Best Response Rate
Complete Response
|
1 Participants
|
|
Best Response Rate
Partial Response
|
3 Participants
|
|
Best Response Rate
Stable Response
|
4 Participants
|
|
Best Response Rate
Progression of Disease
|
4 Participants
|
|
Best Response Rate
Not Entered
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 yearsSubjects will be evaluated for occurrence of AEs at each visit. Events will be characterized and reported. Safety will also be monitored by performing physical exams and routine laboratory procedures. Terminology Criteria for Adverse Events" V4.0 (CTCAE).
Outcome measures
| Measure |
Patients With Advanced Colorectal Cancer
n=16 Participants
This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.
MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.
|
|---|---|
|
Number of Participants Evaluated for Toxicities to Determine Safety
|
16 Participants
|
Adverse Events
Patients With Advanced Colorectal Cancer
Serious events: 8 serious events
Other events: 16 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Patients With Advanced Colorectal Cancer
n=16 participants at risk
This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.
MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • 2 years
|
|
Investigations
Blood bilirubin increased
|
12.5%
2/16 • 2 years
|
|
General disorders
Death NOS
|
12.5%
2/16 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • 2 years
|
|
Infections and infestations
Enterocolitis infectious
|
6.2%
1/16 • 2 years
|
|
General disorders
Fatigue
|
18.8%
3/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
12.5%
2/16 • 2 years
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
|
6.2%
1/16 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.5%
2/16 • 2 years
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • 2 years
|
Other adverse events
| Measure |
Patients With Advanced Colorectal Cancer
n=16 participants at risk
This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.
MEDI4736: Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.
|
|---|---|
|
General disorders
Fatigue
|
43.8%
7/16 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
31.2%
5/16 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.2%
5/16 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
4/16 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
3/16 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
3/16 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.8%
3/16 • 2 years
|
|
Investigations
Platelet count decreased
|
18.8%
3/16 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
2/16 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
2/16 • 2 years
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
2/16 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • 2 years
|
|
Nervous system disorders
Tremor
|
12.5%
2/16 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Ataxia
|
6.2%
1/16 • 2 years
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • 2 years
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16 • 2 years
|
|
General disorders
Edema limbs
|
6.2%
1/16 • 2 years
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • 2 years
|
|
Vascular disorders
Hot flashes
|
6.2%
1/16 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
1/16 • 2 years
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
1/16 • 2 years
|
|
Infections and infestations
Rash pustular
|
6.2%
1/16 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • 2 years
|
Additional Information
Dr. Neil Segal, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place