Trial Outcomes & Findings for Fecal Microbiota Transplant (FMT) in Melanoma Patients (NCT NCT03341143)
NCT ID: NCT03341143
Last Updated: 2024-10-30
Results Overview
Number of patients with patients with objective responses (Complete Response (CR) + Partial Response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2024-10-30
Participant Flow
Participant milestones
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fecal Microbiota Transplant (FMT) in Melanoma Patients
Baseline characteristics by cohort
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=20 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
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Age, Continuous
|
58.85 years
STANDARD_DEVIATION 13.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All treated patients who were evaluable for radiologic response.
Number of patients with patients with objective responses (Complete Response (CR) + Partial Response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. 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.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=13 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
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Objective Response Rate (ORR)
Partial Response
|
2 Participants
|
|
Objective Response Rate (ORR)
Progressive Disease
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1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All treated patients who were evaluable for radiologic response.
Number of patients with patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. 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. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=13 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
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Disease Control Rate (DCR)
Partial Response (PR)
|
2 Participants
|
|
Disease Control Rate (DCR)
Stable Disease (SD)
|
10 Participants
|
|
Disease Control Rate (DCR)
Complete Response (CR)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All treated patients
Number of patients who experienced grade III or grade IV toxicities per CTCAE v5.0, related to study treatment.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=2 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
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Incidence of Grade III/IV Toxicities
Atrial fibrillation
|
1 Participants
|
|
Incidence of Grade III/IV Toxicities
Lymphocyte count decreased
|
1 Participants
|
|
Incidence of Grade III/IV Toxicities
Arthralgia
|
1 Participants
|
|
Incidence of Grade III/IV Toxicities
Myopathy
|
1 Participants
|
|
Incidence of Grade III/IV Toxicities
Hyponatremia
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All treated patients who were evaluable for radiologic response.
Time from first response to to treatment until documented disease progression by RECIST v1.1 or death due to any cause. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=11 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
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Progression-free Survival (PFS)
|
9 months
Interval 3.0 to 32.0
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: All treated patients who were evaluable for radiologic response.
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 6 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=10 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
|
6-month Progression-free Survival (PFS)
|
61 percentage of participants
Interval 35.0 to 79.0
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: All treated patients who were evaluable for radiologic response.
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 12 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=5 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
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12-month Progression-free Survival (PFS)
|
34 percentage of participants
Interval 13.0 to 57.0
|
SECONDARY outcome
Timeframe: At 24 monthsPopulation: All treated patients who were evaluable for radiologic response.
Percentage of patients who did not experience documented disease progression by RECIST v1.1 or death due to any cause from start of treatment until 24 months post treatment initiation. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=4 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
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|---|---|
|
24-month Progression-free Survival (PFS)
|
34 percentage of participants
Interval 13.0 to 57.0
|
SECONDARY outcome
Timeframe: Up to 6.5 yearsPopulation: All enrolled patients followed for survival.
Overall survival (OS), defined as time from first dose of study treatment until death due to any cause.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=20 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
|
|---|---|
|
Overall Survival (OS)
|
34 months
Interval 6.0 to
Upper bound of 95%CI not reached
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: All study patients followed for survival.
Percentage of patients alive at 6 months from first dose of study treatment.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=14 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
|
|---|---|
|
6-month Overall Survival (OS)
|
75 percentage of participants
Interval 49.0 to 89.0
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: All enrolled patients followed for survival.
Percentage of patients alive at 12 months from first dose of study treatment.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=11 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
|
|---|---|
|
12-month Overall Survival (OS)
|
64 percentage of participants
Interval 39.0 to 81.0
|
SECONDARY outcome
Timeframe: At 24 monthsPopulation: All enrolled patients followed for survival.
Percentage of patients alive at 24 months from first dose of study treatment.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=10 Participants
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
|
|---|---|
|
24-month Overall Survival (OS)
|
64 percentage of participants
Interval 39.0 to 81.0
|
SECONDARY outcome
Timeframe: 4 yearsQuantitative differences in CD8 + PD1+ T cells (measured by percent of total cells) and MFI (staining intensity) between pre- and post- treatment samples from patients that respond and patients that do not respond (per RECIST 1.1), to study treatment. Information available in linked citation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsChanges in CD8+ T-cell receptor diversity (quantified/determined by using Immunoseq analyses), CD4 + Foxp3 + T regulatory cells, CD56 + NK cells, CD68+ dendritic cells between pre- and post- treatment samples from patients that respond and patients that do not respond (per RECIST 1.1), to study treatment. Information available in linked citation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsFunctional analyses (measured by percent of total cells) expressing IFNgamma) and MFI (staining intensity) between pre- and post- treatment samples from patients that respond and patients that do not respond (per RECIST 1.1), to study treatment. Information available in linked citation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsChanges in bacterial abundance (quantified by the operational taxonomic unit (OTU)) which indicates the number of different species present along with the representative proportion of each species in the sample) and bacterial diversity (quantified by alpha diversity which is defined by the Shannon Index and quantifies both the organismal richness of a sample and the evenness of the organisms' abundance distribution), between pre- and post- treatment samples from patients that respond and patients that do not respond (per RECIST 1.1) to study treatment. Information available in linked citation.
Outcome measures
Outcome data not reported
Adverse Events
Fecal Microbiota Transplant (FMT) With Pembrolizumab
Serious events: 12 serious events
Other events: 19 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=20 participants at risk
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Failure to Thrive
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Cellulitis
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
specifymyopathy
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Localized edema
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Pain
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Skin and subcutaneous tissue disorders
Groin Abscess
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Surgical and medical procedures
left hip closed reduction possible open reduction/revision
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Surgical and medical procedures
left lateral hip excision
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Surgical and medical procedures
resection of tumor
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Surgical and medical procedures
right neck dissection
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
16.7%
1/6 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
Other adverse events
| Measure |
Fecal Microbiota Transplant (FMT) With Pembrolizumab
n=20 participants at risk
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
Fecal Microbiota Transplant with Pembrolizumab: FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
5/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Alkaline phosphatase increased
|
30.0%
6/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
70.0%
14/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
5/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
B12 deficiency
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Gastrointestinal disorders
Bloating
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Cardiac disorders
bradycardia
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
35.0%
7/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Creatinine increased
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
creatinine increased
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
decreased albumin
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
decreased chloride
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Decreased protein
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
decreased protein
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Decreased temperature
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Endocrine disorders
decreased testosterone
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Surgical and medical procedures
Delayed Wound Healing of biopsy site
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
7/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
elevated TSH
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Eye disorders
Eye swelling
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Fatigue
|
35.0%
7/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Fever
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Flu like symptoms
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Skin and subcutaneous tissue disorders
Groin Abscess
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Hemoptysis
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Hip Pain
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
4/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
hyperphosphatemia
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Vascular disorders
Hypertension
|
60.0%
12/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.0%
4/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
4/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
6/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
4/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
12/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
5/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Hypovolemia
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Injury, poisoning and procedural complications
ib fractures
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Inceased phos
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Increased Absolute Neutrophils
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
increased bilirubin
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
increased BUN
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
increased creatinine
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Increased LDH
|
35.0%
7/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
increased LDH
|
25.0%
5/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
increased phosphorus
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Increased Platelets
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Increased ptt
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Increased TSH
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
increased TSH
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Metabolism and nutrition disorders
increased uric acid
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Increased WBC
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Increased White blood cells
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
INR increased
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
intermittent weakness
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Knee pain
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
LDH Increased
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
LDH increased
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Leukocytosis
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Infections and infestations
Lung infection
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Lymphocyte count decreased
|
35.0%
7/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Lymphocyte count increased
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
moonface
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Myopathies
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
myopathy
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Neutrophil count decreased
|
20.0%
4/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Pain
|
35.0%
7/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Musculoskeletal and connective tissue disorders
pain - bicep
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Platelet count decreased
|
20.0%
4/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
pruritic mass - right lower flank
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Skin and subcutaneous tissue disorders
rash
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Cardiac disorders
Sinus bradycardia
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Spinal Stenosis
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
T6-T10 Spinal Infarct
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Cardiac disorders
tachycardia
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Nervous system disorders
Tremor
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
troponin T increased
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
TSH increased
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
General disorders
Tumor Lysis Syndrome
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Vitiligo
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Weight gain
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
Weight loss
|
10.0%
2/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Investigations
White blood cell decreased
|
15.0%
3/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
|
Infections and infestations
Wound infection
|
5.0%
1/20 • All-Cause Mortality: up to 6.5 years Serious and Adverse Events: up to 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place