Trial Outcomes & Findings for Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q) (NCT NCT04439110)
NCT ID: NCT04439110
Last Updated: 2025-11-21
Results Overview
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided binomial exact confidence interval will be calculated for ORR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registration
Results posted on
2025-11-21
Participant Flow
Subprotocol Q was activated on August 12, 2015. A total of 58 patients were assigned to this arm after screening, all from screening cohort. Of the 58 patients, 38 patients were enrolled to arm Q between November 19, 2015 and March 20, 2017.
To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol Q, patients had to have a tumor ERBB2 copy number of \>7.
Participant milestones
| Measure |
Treatment (Trastuzumab Emtansine)
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab Emtansine: Given IV
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
Eligible
|
36
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
Treatment (Trastuzumab Emtansine)
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab Emtansine: Given IV
|
|---|---|
|
Overall Study
Ineligible
|
2
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease proression
|
25
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Alternative therapy
|
1
|
|
Overall Study
Other complicating disease
|
1
|
|
Overall Study
Personal reasons
|
1
|
|
Overall Study
Still on treatment
|
1
|
Baseline Characteristics
Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q)
Baseline characteristics by cohort
| Measure |
Treatment (Trastuzumab Emtansine)
n=36 Participants
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab Emtansine: Given IV
|
|---|---|
|
Age, Continuous
|
64 years
n=68 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments occurred at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registrationPopulation: Patients who were eligible and received protocol treatment
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided binomial exact confidence interval will be calculated for ORR.
Outcome measures
| Measure |
Treatment (Trastuzumab Emtansine)
n=36 Participants
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab Emtansine: Given IV
|
|---|---|
|
Objective Response Rate (ORR)
|
2 percentage of participants
Interval 1.0 to 16.5
|
SECONDARY outcome
Timeframe: Assessed at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registrationPopulation: Patients who were eligible and received protocol treatment
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
Outcome measures
| Measure |
Treatment (Trastuzumab Emtansine)
n=36 Participants
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab Emtansine: Given IV
|
|---|---|
|
6 Months Progression-free Survival (PFS) Rate
|
23.6 percentage of participants
Interval 14.2 to 39.2
|
SECONDARY outcome
Timeframe: Assessed at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registrationPopulation: Patients who were eligible and received protocol treatment
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Median PFS will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Trastuzumab Emtansine)
n=36 Participants
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab Emtansine: Given IV
|
|---|---|
|
Progression Free Survival (PFS)
|
3.1 months
Interval 2.1 to 4.4
|
Adverse Events
Treatment (Trastuzumab Emtansine)
Serious events: 12 serious events
Other events: 29 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Treatment (Trastuzumab Emtansine)
n=38 participants at risk
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab Emtansine: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
General disorders
Fatigue
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
General disorders
Fever
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Gastrointestinal disorders
Ileal obstruction
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Infections and infestations
Upper respiratory infection
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Alkaline phosphatase increased
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Lymphocyte count decreased
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Neutrophil count decreased
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Platelet count decreased
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Investigations - Other, specify
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Eye disorders
Blurred vision
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Renal and urinary disorders
Hematuria
|
2.6%
1/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
Other adverse events
| Measure |
Treatment (Trastuzumab Emtansine)
n=38 participants at risk
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Trastuzumab Emtansine: Given IV
|
|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Gastrointestinal disorders
Nausea
|
21.1%
8/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
8/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Immune system disorders
Allergic reaction
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
4/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Alkaline phosphatase increased
|
15.8%
6/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Aspartate aminotransferase increased
|
28.9%
11/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Blood bilirubin increased
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Creatinine increased
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Lymphocyte count decreased
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Neutrophil count decreased
|
10.5%
4/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Platelet count decreased
|
28.9%
11/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
Weight loss
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Investigations
White blood cell decreased
|
10.5%
4/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.2%
5/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Blood and lymphatic system disorders
Anemia
|
23.7%
9/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
General disorders
Chills
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
General disorders
Edema limbs
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
General disorders
Fatigue
|
36.8%
14/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
General disorders
Fever
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
General disorders
Gait disturbance
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.5%
4/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Nervous system disorders
Headache
|
10.5%
4/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.5%
4/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.9%
3/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
|
Vascular disorders
Hypertension
|
5.3%
2/38 • Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60