Trial Outcomes & Findings for Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma (NCT NCT02306850)
NCT ID: NCT02306850
Last Updated: 2019-06-20
Results Overview
'Resectability rate' is defined as the proportion of subjects in the trial that were unresectable at baseline who after treatment with pembrolizumab are now eligible for curative resection with complete metastectomy. The primary endpoint "resectability rate" is merely a novel statistical approach; it has no bearing on the duration of treatment that an individual patient may receive during the trial.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-06-20
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).
Assess the efficacy of neoadjuvant pembrolizumab in improving resectability rates in subjects with unresectable Stage III or unresectable Stage IV melanoma. Patients are eligible for study entry if complete metastectomy would be possible if the burden of disease can be decreased in size by up to 50%.
Pembrolizumab: subjects will receive pembrolizumab, 200 mg infusions, every 3 weeks. Eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
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|---|---|
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Overall Study
STARTED
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10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).
Assess the efficacy of neoadjuvant pembrolizumab in improving resectability rates in subjects with unresectable Stage III or unresectable Stage IV melanoma. Patients are eligible for study entry if complete metastectomy would be possible if the burden of disease can be decreased in size by up to 50%.
Pembrolizumab: subjects will receive pembrolizumab, 200 mg infusions, every 3 weeks. Eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
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|---|---|
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Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=10 Participants
Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).
Pembrolizumab: subjects will receive pembrolizumab, 200 mg infusions, every 3 weeks. Eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
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|---|---|
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Age, Continuous
|
66.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 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
|
10 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
|
|
Region of Enrollment
United States
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10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks'Resectability rate' is defined as the proportion of subjects in the trial that were unresectable at baseline who after treatment with pembrolizumab are now eligible for curative resection with complete metastectomy. The primary endpoint "resectability rate" is merely a novel statistical approach; it has no bearing on the duration of treatment that an individual patient may receive during the trial.
Outcome measures
| Measure |
Pembrolizumab
n=10 Participants
Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).
Pembrolizumab: subjects will receive pembrolizumab, 200 mg infusions, every 3 weeks. Eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
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|---|---|
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Resectability Rate
Resectable
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8 Participants
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Resectability Rate
Unresectable
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2 Participants
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SECONDARY outcome
Timeframe: 24 weeksResponse to treatment
Outcome measures
| Measure |
Pembrolizumab
n=10 Participants
Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).
Pembrolizumab: subjects will receive pembrolizumab, 200 mg infusions, every 3 weeks. Eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
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|---|---|
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Response
Complete Response
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1 Participants
|
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Response
Resectable Partial Response
|
7 Participants
|
|
Response
Resectable Progression of Disease
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1 Participants
|
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Response
Progression of Disease
|
1 Participants
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Adverse Events
Pembrolizumab
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=10 participants at risk
Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).
Pembrolizumab: At the Treatment Initiation Visit (Baseline/Day 1), subjects will begin treatment with IV pembrolizumab 200 mg infusions every 3 weeks. As in previous pembrolizumab trials, eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
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|---|---|
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Cardiac disorders
Chest Pain
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Endocrine disorders
Hypophysitis
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Gastrointestinal disorders
Sclerosing Mesenteritis
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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Other adverse events
| Measure |
Pembrolizumab
n=10 participants at risk
Open-label non-randomized trial. All subjects will receive active drug (pembrolizumab).
Pembrolizumab: At the Treatment Initiation Visit (Baseline/Day 1), subjects will begin treatment with IV pembrolizumab 200 mg infusions every 3 weeks. As in previous pembrolizumab trials, eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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Musculoskeletal and connective tissue disorders
Arthralgia
|
40.0%
4/10 • Number of events 4 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
30.0%
3/10 • Number of events 3 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 4 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
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Nervous system disorders
Dizzy
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • Number of events 3 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Skin and subcutaneous tissue disorders
Folliculitis
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
4/10 • Number of events 4 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Musculoskeletal and connective tissue disorders
Arm Pain
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Nervous system disorders
Neuropathy
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Musculoskeletal and connective tissue disorders
Leg Pain
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Gastrointestinal disorders
Early Satiety
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Eye disorders
Vision Changes
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Injury, poisoning and procedural complications
Postoperative Pain
|
30.0%
3/10 • Number of events 3 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Skin and subcutaneous tissue disorders
cyst
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Injury, poisoning and procedural complications
Postoperative Edema
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Injury, poisoning and procedural complications
Postoperative Erythema
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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|
Investigations
Alanine Aminotransferase Increased
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Investigations
Aspartate Aminotransferase Increased
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Investigations
Alkaline Phosphatase Increased
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Infections and infestations
Sinus Infection
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Gastrointestinal disorders
Tooth Pain
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Renal and urinary disorders
Nocturia
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Musculoskeletal and connective tissue disorders
Weak Grip
|
20.0%
2/10 • Number of events 3 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
General disorders
Edema Axilla
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
General disorders
Peripheral Edema
|
20.0%
2/10 • Number of events 2 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Musculoskeletal and connective tissue disorders
Thumb Cramp
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain
|
10.0%
1/10 • Number of events 1 • 24 months or: Subjects who meet all of the following criteria may discontinue follow up prior to 24 months: 1. CR or rPR with complete metastectomy has been confirmed. 2. Patient has received at least 24 weeks (8 cycles) of pembrolizumab therapy. 3. Patient has received at least 2 cycles of pembrolizumab after CR or rPR with complete metastectomy is documented.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place