Trial Outcomes & Findings for Pembrolizumab With or Without Axitinib for Clear Cell Kidney Cancer in Patients Undergoing Surgery (NCT NCT04370509)
NCT ID: NCT04370509
Last Updated: 2025-11-19
Results Overview
TIICs will be analyzed in pre- and post-pembrolizumab-based treatment tumor specimens. The proportion of participants with a \>=2-fold increase (from pre- to post-treatment) in the number of TIICs will be calculated.
TERMINATED
PHASE2
6 participants
Baseline to cytoreductive nephrectomy (CN)/metastasectomy (MET), up to 1 year
2025-11-19
Participant Flow
The study was closed to enrollment by the sponsor before enrollment in Cohort B was made available to participants. Therefore, no participants could be enrolled in Cohort B.
Participant milestones
| Measure |
Cohort A (Pembrolizumab Monotherapy)
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with progressive disease (PD) may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
Cohort B (Pembrolizumab + VEGF-TKI)
Preoperative treatment consists of 200 mg pembrolizumab IV on day 1 of each cycle, and 5mg axitinib (a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)) orally (PO) twice a day (BID) on days 1-42 of each cycle. Axitinib maybe titered in select patients after cycle 1. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of pre-operative treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with an R0 or R1 resection receive 400 mg pembrolizumab and 1, 3, 5, 7 or 10 mg axitinib PO BID every 42 days for up to 9 cycles (1 year), and patients with an R2 resection receive pembrolizumab IV and axitinib PO BID every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
|
Overall Study
Completed Cytoreductive Nephrectomy (CN) or Metastasectomy (MET)
|
5
|
0
|
|
Overall Study
Received 1 Year of Pembrolizumab
|
4
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort A (Pembrolizumab Monotherapy)
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with progressive disease (PD) may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
Cohort B (Pembrolizumab + VEGF-TKI)
Preoperative treatment consists of 200 mg pembrolizumab IV on day 1 of each cycle, and 5mg axitinib (a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)) orally (PO) twice a day (BID) on days 1-42 of each cycle. Axitinib maybe titered in select patients after cycle 1. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of pre-operative treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with an R0 or R1 resection receive 400 mg pembrolizumab and 1, 3, 5, 7 or 10 mg axitinib PO BID every 42 days for up to 9 cycles (1 year), and patients with an R2 resection receive pembrolizumab IV and axitinib PO BID every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Did not receive post-op Pembrolizumab
|
1
|
0
|
Baseline Characteristics
Pembrolizumab With or Without Axitinib for Clear Cell Kidney Cancer in Patients Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=6 Participants
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
Cohort B (Pembrolizumab + VEGF-TKI)
Preoperative treatment consists of 200 mg pembrolizumab IV on day 1 of each cycle, and 5mg axitinib (a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)) PO BID on days 1-42 of each cycle. Axitinib maybe titered in select patients after cycle 1. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of pre-operative treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with an R0 or R1 resection receive 400 mg pembrolizumab and 1, 3, 5, 7 or 10 mg axitinib PO BID every 42 days for up to 9 cycles (1 year), and patients with an R2 resection receive pembrolizumab IV and axitinib PO BID every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years old
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Age, Customized
50-59 years old
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Age, Customized
60-69 years old
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Age, Customized
70-79 years old
|
3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
|
—
|
6 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to cytoreductive nephrectomy (CN)/metastasectomy (MET), up to 1 yearPopulation: The analysis for this endpoint could not be completed due to insufficient funds for the laboratory experiments to determine the number of tumor-infiltrating immune cells (TIICs), when the collaborating sponsor (Merck Sharp and Dohme) terminated the study prematurely. Therefore, no plans currently exist to fund analysis of this endpoint in the future.
TIICs will be analyzed in pre- and post-pembrolizumab-based treatment tumor specimens. The proportion of participants with a \>=2-fold increase (from pre- to post-treatment) in the number of TIICs will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearObjective response rate in pre-operative pembrolizumab-based therapy in participants with advanced renal cell carcinoma (RCC) will be defined as proportion of participants who obtain a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors 1.1 modified to allow a maximum of 10 target lesions or 5 target lesions per organ. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; Partial Response (PR), \>=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=6 Participants
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response Rate (ORR) in Pre-operative Pembrolizumab-based Therapy
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearThe DFS for continued pembrolizumab-based therapy in participants with advanced RCC will be assessed in participants who achieve CR, PR, or stable disease (SD) followed by R0 resection, and is defined as the proportion of those participants who remain disease-free at the end of the 1 year continued treatment period (1-year DFS rate)
Outcome measures
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=4 Participants
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Disease-Free Survival Rate (DFS) at 1 Year for Participants Who Obtain CR or PR/SD With R0 Resection and Are Treated 1 Year of Pembrolizumab-based Therapy
|
1.0 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe DFS for continued pembrolizumab-based therapy in participants with advanced RCC will be assessed in participants who achieve CR, PR, or stable disease (SD) followed by R0 resection, and is defined as the proportion of those participants who remain disease-free at 1 year following the end of the continued treatment period (2-year DFS rate)
Outcome measures
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=4 Participants
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Disease-Free Survival Rate (DFS) at 2 Years for Participants Who Obtain CR or PR/SD With R0 Resection and Are Treated 1 Year of Pembrolizumab-based Therapy
|
0.5 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsIn participants who achieve CR, PR or stable disease (SD) followed by R0 resection, median time participants remain disease-free will be reported using the Kaplan-Meier estimate.
Outcome measures
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=4 Participants
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median DFS for Participants Who Obtain CR or PR/SD With R0 Resection and Are Treated 1 Year of Pembrolizumab-based Therapy
|
651 days
Interval 602.0 to
There were insufficient number of events so the upper limit could not be reached.
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: No participants achieved PR/SD with residual disease; therefore, data were not collected from any participants.
PFS for participants who achieve PR/SD with residual disease following CN/MET and are also treated with 1 year of pembrolizumab-based therapy is defined as the proportion of participants who remain progression-free at the end of the 1 year continued treatment period (1-year PFS rate)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No participants achieved PR/SD with residual disease; therefore, data were not collected from any participants.
PFS in participants who achieve PR/SD with residual disease following CN/MET and are also treated with 1 year of pembrolizumab-based therapy is defined as the proportion of participants who remain progression-free at 1 year following the end of the continued treatment period (2-year PFS rate)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No participants achieved PR/SD with residual disease; therefore, data were not collected from any participants.
The Median PFS for participants who obtain PR/SD and have residual disease following CN/MET and are treated with 1 year of pembrolizumab-based therapy will be reported as the median time participants remain progression-free using the Kaplan-Meier estimate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsAdverse events classified as being definitely, possibly, or probably related to study treatment will be assessed and reported using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Outcome measures
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=6 Participants
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants Reporting Treatment-related Adverse Events
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: One participant withdrew from the study prior to receiving surgery and was excluded from this endpoint analysis.
The number of participants reporting surgical complications by grade using the Clavien-Dindo Classification of Surgical Complications will be reported.
Outcome measures
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=5 Participants
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants Reporting Surgical Complications
|
0 Participants
|
Adverse Events
Cohort A (Pembrolizumab Monotherapy)
Serious adverse events
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=6 participants at risk
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Cohort A (Pembrolizumab Monotherapy)
n=6 participants at risk
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Creatinine increased
|
50.0%
3/6 • Number of events 4 • Up to 2 years
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 4 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
33.3%
2/6 • Number of events 3 • Up to 2 years
|
|
Cardiac disorders
Myocarditis
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Hypophysitis
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 2 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • Number of events 10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
3/6 • Number of events 4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
33.3%
2/6 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
General disorders
Edema limbs
|
33.3%
2/6 • Number of events 7 • Up to 2 years
|
Additional Information
Dr. David Oh, MD, PhD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place