Trial Outcomes & Findings for Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma (NCT NCT03325101)
NCT ID: NCT03325101
Last Updated: 2025-06-12
Results Overview
The primary outcome of the Phase I portion of this trial was to establish the tolerability of the proposed treatment schedule in order to move it forward into the Phase II portion of the trial. A maximum of 6 patients was to be enrolled onto the Schedule 1. If at most one of these 6 patients developed a DLT during the first 3 treatment cycles, then Schedule #1 would be carried forward to the Phase II portion of the trial. If not, then an additional 6 patients would be treated with a modified Schedule 1 where Pembrolizumab was eliminated from cycles 2 \& 3. Dose-limiting toxicity (DLT) were defined as the following possibly, probably, or definitely related AEs to protocol therapy during first 3 treatment cycles: Grade 3+ infusion reactions, acute kidney injury, chronic kidney disease, pneumonitis; or Grade 2 infusion reactions, acute kidney injury, chronic kidney disease or pneumonitis that does not resolve to Grade 0-1 within 21 days.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 3 months (3 cycles of 21 days and an additional 7 days for Cycle 1)
Results posted on
2025-06-12
Participant Flow
This Phase I/II clinical trial was designed to identify a treatment schedule for pembrolizumab in combination with cryoablation and intra-tumoral injection of mature dendritic cells (mDCs) with an acceptable safety profile (Phase 1) and then to assess anti-tumor activity (Phase II). The trial opened to enrollment November 15, 2017. The trial closed due to poor accrual on July 21, 2021, having enrolled 7 pts onto Phase I Schedule 1 cohort. The final patient occurred June 14, 2020.
Participant milestones
| Measure |
Treatment (Apheresis, Pembrolizumab, Cryosurgery, Mature Dendritic Cells [mDCs])
Phase I Schedule 1 Treatment cohort where cycle length is 21 days: On D1C1, patients undergo apheresis and receive 200mg pembrolizumab IV over 30 minutes. On C2D1, patients will receive 200 mg pembrolizumab administered IV over 30 minutes. Within 36 hours of receiving pembrolizumab, a single metastatic lesion will be biopsied and cryoablated (using conventional freeze-thaw-freeze cycle). After the lesion has thawed, a 22 G needle will be placed under ultrasound or CT-guidance into the ablated portion of the lesion. The mature Dendritic Cells (total mDCS: 30-60 x10\^6) will be administered through this needle over different areas of the cryoablated region and then flushed with 1 ml of sterile saline. Prevnar13® will be injected into the ablated portion of the lesion after administration of mDCs. On C3D1 the same treatment will be administered to a different metastatic lesion. C4D1 and D1 of all subsequent cycle patients will receive 200 mg pembrolizumab IV over 30 minutes. Treatment continues until disease progression or a maximum of 24 months post registration
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma
Baseline characteristics by cohort
| Measure |
Phase I Schedule 1
n=7 Participants
Phase I Schedule 1 Treatment cohort where cycle length is 21 days: On D1C1, patients undergo apheresis and receive 200mg pembrolizumab IV over 30 minutes. On C2D1, patients will receive 200 mg pembrolizumab administered IV over 30 minutes. Within 36 hours of receiving pembrolizumab, a single metastatic lesion will be biopsied and cryoablated (using conventional freeze-thaw-freeze cycle). After the lesion has thawed, a 22 G needle will be placed under ultrasound or CT-guidance into the ablated portion of the lesion. The mature Dendritic Cells (total mDCS: 30-60 x10\^6) will be administered through this needle over different areas of the cryoablated region and then flushed with 1ml of sterile saline. Prevnar13® will be injected into the ablated portion of the lesion after administration of mDCs. On C3D1 the same treatment will be administered to a different metastatic lesion. C4D1 and D1 of all subsequent cycle patients will receive 200mg pembrolizumab IV over 30 minutes. Treatment continues until disease progression or a maximum of 24 months post registration.
|
Phase I Schedule -1
hase I Schedule 1 Treatment cohort where cycle length is 21 days: On D1C1, patients undergo apheresis and receive 200mg pembrolizumab IV over 30 minutes. On C2D1, a single metastatic lesion will be biopsied and cryoablated (using conventional freeze-thaw-freeze cycle). After the lesion has thawed, a 22 G needle will be placed under ultrasound or CT-guidance into the ablated portion of the lesion. The mature Dendritic Cells (total mDCS: 30-60 x10\^6) will be administered through this needle over different areas of the cryoablated region and then flushed with 1ml of sterile saline. Prevnar13® will be injected into the ablated portion of the lesion after administration of mDCs. On C3D1 the same treatment will be administered to a different metastatic lesion. C4D1 and D1 of all subsequent cycle patients will receive 200mg pembrolizumab IV over 30 minutes. Treatment continues until disease progression or a maximum of 24 months post registration.
|
Phase II Schedule
Phase II Schedule based on the findings of the Phase I portion of the study
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age at study entry
|
65.4 years
n=5 Participants
|
—
|
—
|
65.4 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
—
|
—
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
—
|
—
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
—
|
—
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
—
|
—
|
7 participants
n=4 Participants
|
|
ECOG Performance Status at Study entry
ECOG PS = 0
|
5 Participants
n=5 Participants
|
—
|
—
|
5 Participants
n=4 Participants
|
|
ECOG Performance Status at Study entry
ECOG PS = 1
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months (3 cycles of 21 days and an additional 7 days for Cycle 1)Population: All patient who began protocol treatment.
The primary outcome of the Phase I portion of this trial was to establish the tolerability of the proposed treatment schedule in order to move it forward into the Phase II portion of the trial. A maximum of 6 patients was to be enrolled onto the Schedule 1. If at most one of these 6 patients developed a DLT during the first 3 treatment cycles, then Schedule #1 would be carried forward to the Phase II portion of the trial. If not, then an additional 6 patients would be treated with a modified Schedule 1 where Pembrolizumab was eliminated from cycles 2 \& 3. Dose-limiting toxicity (DLT) were defined as the following possibly, probably, or definitely related AEs to protocol therapy during first 3 treatment cycles: Grade 3+ infusion reactions, acute kidney injury, chronic kidney disease, pneumonitis; or Grade 2 infusion reactions, acute kidney injury, chronic kidney disease or pneumonitis that does not resolve to Grade 0-1 within 21 days.
Outcome measures
| Measure |
Phase I Schedule 1
n=7 Participants
Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production
Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes on Cycle 1 Day 1.
Cycle 2 \& Cycle 3 Day 1: Pembrolizumab 200 mg is administered by IV over 30 minutes
Cycle 2 \& Cycle 3 either Day 1 or Day 2 (within 36 hours of receiving pembrolizumab): patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3.
Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
|
Phase I Schedule 2
Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production
Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes on Cycle 1 Day 1.
Cycle 2 \& Cycle 3 Day 1 or Day 2: patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3.
Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
|
Phase II Schedule
Phase II Schedule depends on the Phase I findings
|
|---|---|---|---|
|
Number of Participants Who Developed a DLT During the First 3 Cycles of Treatment.
Number of patients who developed a DLT on Schedule 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Developed a DLT During the First 3 Cycles of Treatment.
Number of patients who did not develop a DLT on Schedule 1
|
7 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 months (through study completion)Population: All patients who were eligible and started protocol treatment
Assessed using Common Terminology Criteria for Adverse Events (CTCAE).
Outcome measures
| Measure |
Phase I Schedule 1
n=7 Participants
Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production
Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes on Cycle 1 Day 1.
Cycle 2 \& Cycle 3 Day 1: Pembrolizumab 200 mg is administered by IV over 30 minutes
Cycle 2 \& Cycle 3 either Day 1 or Day 2 (within 36 hours of receiving pembrolizumab): patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3.
Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
|
Phase I Schedule 2
Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production
Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes on Cycle 1 Day 1.
Cycle 2 \& Cycle 3 Day 1 or Day 2: patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3.
Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
|
Phase II Schedule
Phase II Schedule depends on the Phase I findings
|
|---|---|---|---|
|
Incidence of Adverse Events
grade 3 headache
|
1 Participants
|
—
|
—
|
|
Incidence of Adverse Events
grade 2 creatinine increase
|
1 Participants
|
—
|
—
|
|
Incidence of Adverse Events
grade 2 aspartate aminotransferase increase
|
1 Participants
|
—
|
—
|
|
Incidence of Adverse Events
grade 2 fatigue
|
2 Participants
|
—
|
—
|
|
Incidence of Adverse Events
grade 2 fever
|
1 Participants
|
—
|
—
|
|
Incidence of Adverse Events
grade 2 hyperglycemia
|
2 Participants
|
—
|
—
|
|
Incidence of Adverse Events
grade 2 pain
|
2 Participants
|
—
|
—
|
|
Incidence of Adverse Events
grade 3 hypertension
|
1 Participants
|
—
|
—
|
|
Incidence of Adverse Events
grade 2 blood bilirubin increase
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 months (through study completion)Time from registration to death due to any cause
Outcome measures
| Measure |
Phase I Schedule 1
n=7 Participants
Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production
Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes on Cycle 1 Day 1.
Cycle 2 \& Cycle 3 Day 1: Pembrolizumab 200 mg is administered by IV over 30 minutes
Cycle 2 \& Cycle 3 either Day 1 or Day 2 (within 36 hours of receiving pembrolizumab): patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3.
Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
|
Phase I Schedule 2
Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production
Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes on Cycle 1 Day 1.
Cycle 2 \& Cycle 3 Day 1 or Day 2: patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3.
Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
|
Phase II Schedule
Phase II Schedule depends on the Phase I findings
|
|---|---|---|---|
|
Overall Survival
|
211 days
Interval 11.0 to 751.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 months (through study completion)Population: The trial closed to enrollment following Phase I Schedule 1 testing due to poor accrual.
time from registration to disease progression (per RECIST criteria) or death due to any cause
Outcome measures
| Measure |
Phase I Schedule 1
n=7 Participants
Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production
Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes on Cycle 1 Day 1.
Cycle 2 \& Cycle 3 Day 1: Pembrolizumab 200 mg is administered by IV over 30 minutes
Cycle 2 \& Cycle 3 either Day 1 or Day 2 (within 36 hours of receiving pembrolizumab): patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3.
Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
|
Phase I Schedule 2
Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production
Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes on Cycle 1 Day 1.
Cycle 2 \& Cycle 3 Day 1 or Day 2: patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3.
Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
|
Phase II Schedule
Phase II Schedule depends on the Phase I findings
|
|---|---|---|---|
|
Progression-free Survival Time
|
88 days
Interval 11.0 to 113.0
|
—
|
—
|
Adverse Events
Phase I Schedule 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 7 deaths
Phase I Schedule -1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II Schedule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Schedule 1
n=7 participants at risk
Phase I Schedule 1 Treatment cohort where cycle length is 21 days: On D1C1, patients undergo apheresis and receive 200mg pembrolizumab IV over 30 minutes. On C2D1, patients will receive 200 mg pembrolizumab administered IV over 30 minutes. Within 36 hours of receiving pembrolizumab, a single metastatic lesion will be biopsied and cryoablated (using conventional freeze-thaw-freeze cycle). After the lesion has thawed, a 22 G needle will be placed under ultrasound or CT-guidance into the ablated portion of the lesion. The mature Dendritic Cells (total mDCS: 30-60 x10\^6) will be administered through this needle over different areas of the cryoablated region and then flushed with 1ml of sterile saline. Prevnar13® will be injected into the ablated portion of the lesion after administration of mDCs. On C3D1 the same treatment will be administered to a different metastatic lesion. C4D1 and D1 of all subsequent cycle patients will receive 200mg pembrolizumab IV over 30 minutes. Treatment continues until disease progression or a maximum of 24 months post registration.
|
Phase I Schedule -1
Phase I Schedule -1 Treatment cohort where cycle length is 21 days: On D1C1, patients undergo apheresis and receive 200mg pembrolizumab IV over 30 minutes. On C2D1, a single metastatic lesion will be biopsied and cryoablated (using conventional freeze-thaw-freeze cycle). After the lesion has thawed, a 22 G needle will be placed under ultrasound or CT-guidance into the ablated portion of the lesion. The mature Dendritic Cells (total mDCS: 30-60 x10\^6) will be administered through this needle over different areas of the cryoablated region and then flushed with 1ml of sterile saline. Prevnar13® will be injected into the ablated portion of the lesion after administration of mDCs. On C3D1 the same treatment will be administered to a different metastatic lesion. C4D1 and D1 of all subsequent cycle patients will receive 200mg pembrolizumab IV over 30 minutes. Treatment continues until disease progression or a maximum of 24 months post registration.
|
Phase II Schedule
Phase II schedule depends on the result of the Phase I portion of the study
|
|---|---|---|---|
|
Vascular disorders
grade 3 hypertension
|
14.3%
1/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
|
Nervous system disorders
grade 3 headache
|
14.3%
1/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
Other adverse events
| Measure |
Phase I Schedule 1
n=7 participants at risk
Phase I Schedule 1 Treatment cohort where cycle length is 21 days: On D1C1, patients undergo apheresis and receive 200mg pembrolizumab IV over 30 minutes. On C2D1, patients will receive 200 mg pembrolizumab administered IV over 30 minutes. Within 36 hours of receiving pembrolizumab, a single metastatic lesion will be biopsied and cryoablated (using conventional freeze-thaw-freeze cycle). After the lesion has thawed, a 22 G needle will be placed under ultrasound or CT-guidance into the ablated portion of the lesion. The mature Dendritic Cells (total mDCS: 30-60 x10\^6) will be administered through this needle over different areas of the cryoablated region and then flushed with 1ml of sterile saline. Prevnar13® will be injected into the ablated portion of the lesion after administration of mDCs. On C3D1 the same treatment will be administered to a different metastatic lesion. C4D1 and D1 of all subsequent cycle patients will receive 200mg pembrolizumab IV over 30 minutes. Treatment continues until disease progression or a maximum of 24 months post registration.
|
Phase I Schedule -1
Phase I Schedule -1 Treatment cohort where cycle length is 21 days: On D1C1, patients undergo apheresis and receive 200mg pembrolizumab IV over 30 minutes. On C2D1, a single metastatic lesion will be biopsied and cryoablated (using conventional freeze-thaw-freeze cycle). After the lesion has thawed, a 22 G needle will be placed under ultrasound or CT-guidance into the ablated portion of the lesion. The mature Dendritic Cells (total mDCS: 30-60 x10\^6) will be administered through this needle over different areas of the cryoablated region and then flushed with 1ml of sterile saline. Prevnar13® will be injected into the ablated portion of the lesion after administration of mDCs. On C3D1 the same treatment will be administered to a different metastatic lesion. C4D1 and D1 of all subsequent cycle patients will receive 200mg pembrolizumab IV over 30 minutes. Treatment continues until disease progression or a maximum of 24 months post registration.
|
Phase II Schedule
Phase II schedule depends on the result of the Phase I portion of the study
|
|---|---|---|---|
|
Investigations
Grade 2 blood bilirubin increase
|
14.3%
1/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
|
Investigations
Grade 2 Aspartate aminotransferase increased
|
14.3%
1/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
|
Investigations
Grade 2 Creatinine increase
|
14.3%
1/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
|
General disorders
Grade 2 fatigue
|
28.6%
2/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
|
General disorders
Grade 2 fever
|
14.3%
1/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
|
General disorders
Grade 2 pain
|
28.6%
2/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
|
Metabolism and nutrition disorders
Grade 2 hyperglycemia
|
28.6%
2/7 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
—
0/0 • 30 months (through study completion)
CTCAE criteria grade 2 or higher regardless of attribution
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place