Trial Outcomes & Findings for Testing Nivolumab as a Potential Targeted Treatment in Cancers With Mismatch Repair Deficiency (MATCH-Subprotocol Z1D) (NCT NCT04439214)

Last Updated: 2021-04-06

Results Overview

Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response 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. The 90% two-sided binomial exact confidence interval was calculated for ORR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression

Results posted on

2021-04-06

Participant Flow

Subprotocol Z1D was activated in NCI-MATCH on May 31, 2016. Patients enrolled for screening by the MATCH assay between this date and the end of screening enrollment in May 2017, were evaluated for MSH2 and MLH1 expression by immunohistochemistry (IHC). In the end, 47 patients were enrolled to the subprotocol.

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 Z1D, patients had to have complete loss of nuclear expression of MLH1 or MSH2 MMR gene products by IHC.

Participant milestones

Participant milestones
Measure	Treatment (Nivolumab) Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Overall Study STARTED	47
Overall Study Eligible	42
Overall Study Treated	47
Overall Study Treated and Reported Adverse Event Data	46
Overall Study Eligible and Treated	42
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Nivolumab) Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Overall Study Adverse Event	13
Overall Study Disease progression	16
Overall Study Death	1
Overall Study Withdrawal by Subject	2
Overall Study Declining health	1
Overall Study Still receiving treatment at the time of the analysis	9
Overall Study Ineligible	5

Baseline Characteristics

Testing Nivolumab as a Potential Targeted Treatment in Cancers With Mismatch Repair Deficiency (MATCH-Subprotocol Z1D)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Nivolumab) n=42 Participants Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Age, Continuous	60.5 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 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	4 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression

Population: Eligible and treated patients

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=42 Participants Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Overall Response Rate (ORR)	35.7 percentage of participants Interval 23.5 to 49.5

SECONDARY outcome

Timeframe: assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression

Population: Eligible and treated patients

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. The 6-month PFS rate was estimated using the Kaplan-Meier method which can provide a point estimate for any specific time point. 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.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=42 Participants Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
6-month Progression-free Survival (PFS) Rate	51.3 percentage of participants Interval 38.2 to 64.5

SECONDARY outcome

Timeframe: assessed at baseline, then every 8 weeks for the first 2 years, then every 12 weeks in year 3, until disease progression

Population: Eligible and treated patients

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. 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.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=42 Participants Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV
Progression-free Survival (PFS)	6.3 months Interval 3.4 to 13.3

Adverse Events

Treatment (Nivolumab)

Serious events: 20 serious events

Other events: 40 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Nivolumab) n=46 participants at risk Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	17.4% 8/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
General disorders Fatigue	4.3% 2/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Skin and subcutaneous tissue disorders Pruritus	4.3% 2/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Gastrointestinal disorders Nausea	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Gastrointestinal disorders Vomiting	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Infections and infestations Sepsis	4.3% 2/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Infections and infestations Skin infection	4.3% 2/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Injury, poisoning and procedural complications Fall	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Alanine aminotransferase increased	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Alkaline phosphatase increased	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Creatinine increased	4.3% 2/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Ejection fraction decreased	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Weight gain	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Dehydration	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Hyperglycemia	4.3% 2/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Hypocalcemia	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Hypokalemia	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Hyponatremia	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Musculoskeletal and connective tissue disorders Back pain	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Musculoskeletal and connective tissue disorders Flank pain	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Nervous system disorders Encephalopathy	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Nervous system disorders Myelitis	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Renal and urinary disorders Acute kidney injury	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Surgical and medical procedures Surgical and medical procedures - Other, specify	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Vascular disorders Hypotension	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Vascular disorders Peripheral ischemia	2.2% 1/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.

Other adverse events

Other adverse events
Measure	Treatment (Nivolumab) n=46 participants at risk Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	26.1% 12/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
General disorders Edema limbs	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
General disorders Fatigue	45.7% 21/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Skin and subcutaneous tissue disorders Pruritus	15.2% 7/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Skin and subcutaneous tissue disorders Rash maculo-papular	17.4% 8/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Endocrine disorders Hyperthyroidism	15.2% 7/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Endocrine disorders Hypothyroidism	15.2% 7/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Gastrointestinal disorders Diarrhea	13.0% 6/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Gastrointestinal disorders Nausea	13.0% 6/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Alanine aminotransferase increased	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Alkaline phosphatase increased	8.7% 4/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Aspartate aminotransferase increased	13.0% 6/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Creatinine increased	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Lymphocyte count decreased	13.0% 6/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Platelet count decreased	13.0% 6/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations White blood cell decreased	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Investigations Investigations - Other, specify	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Anorexia	15.2% 7/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Hyperglycemia	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Hypoalbuminemia	17.4% 8/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Hypomagnesemia	15.2% 7/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Hyponatremia	8.7% 4/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Musculoskeletal and connective tissue disorders Arthralgia	10.9% 5/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 3/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Nervous system disorders Dizziness	8.7% 4/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Respiratory, thoracic and mediastinal disorders Cough	8.7% 4/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.7% 4/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.
Vascular disorders Hot flashes	8.7% 4/46 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years All the 47 enrolled patients started protocol therapy and followed for survival, but 1 patient had disease progression in cycle 1 and adverse event data were not reported. So adverse events were reported for the 46 patients who reported adverse event data, and all-cause mortality was reported for the 47 patients.

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 16176323012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60