Trial Outcomes & Findings for Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer (NCT NCT02635360)
NCT ID: NCT02635360
Last Updated: 2025-07-03
Results Overview
Expression of immune markers measured at pre and post administration of study drug with chemoradiation will be compared, analyzed and enumerated using QuPath software to provide a cell #/mm2 (not per high power field) and the ratio of CD8+ cells:FoxP3+ cells/mm2 was calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
12 weeks post-chemoradiation
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
Following Chemoradiation
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
46
|
|
Overall Study
COMPLETED
|
42
|
39
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Following Chemoradiation
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Non-Compliance
|
3
|
1
|
|
Overall Study
Disease Progression
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer
Baseline characteristics by cohort
| Measure |
Following Chemoradiation
n=48 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=46 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
n=5 Participants
|
48 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
46 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-chemoradiationExpression of immune markers measured at pre and post administration of study drug with chemoradiation will be compared, analyzed and enumerated using QuPath software to provide a cell #/mm2 (not per high power field) and the ratio of CD8+ cells:FoxP3+ cells/mm2 was calculated.
Outcome measures
| Measure |
Following Chemoradiation
n=37 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=28 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Change in Immunologic Markers Following Combination of Study Drug With Chemoradiation
|
31.31 ratio of cells per mm^2", "CD8+: FoxP3+
Standard Deviation 124.77
|
140.33 ratio of cells per mm^2", "CD8+: FoxP3+
Standard Deviation 812.53
|
PRIMARY outcome
Timeframe: From start of treatment until 12 weeks post-chemoradiationPopulation: Subjects on Treatment
To determine the safety of concurrent chemoradiation in combination with pembrolizumab for the treatment of locally advanced cervical cancer
Outcome measures
| Measure |
Following Chemoradiation
n=48 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=46 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after chemotherapyPopulation: Subjects that completed Radiation Therapy within 56 days.
To estimate rates of complete metabolic response on PET/CT imaging obtained 12 weeks after CRT
Outcome measures
| Measure |
Following Chemoradiation
n=33 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=34 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Metabolic Response Rate on PET/CT Imaging
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until up to 5 years following end of treatmentPopulation: Number of subjects on treatment
To estimate the rates of distant metastasis as the first site of recurrent for patients
Outcome measures
| Measure |
Following Chemoradiation
n=48 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=46 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Incidence of Distant Metastases
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until up to 5 years following end of treatmentPopulation: Number of Subjects on Treatment
To estimate the progression free survival (PFS) in subjects with locally advanced cervical cancer treatment with sequential and concurrent administration of pembrolizumab in relation to CRT
Outcome measures
| Measure |
Following Chemoradiation
n=48 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=46 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Progression Free Survival
|
41 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until up to 5 years following end of treatmentPopulation: Number of subjects on treatment
To estimate the overall survival (OS) in subjects with locally advanced cervical cancer treated with sequential and concurrent administration of pembrolizumab in relation to CRT
Outcome measures
| Measure |
Following Chemoradiation
n=48 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=46 Participants
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Overall Survival
|
42 Participants
|
41 Participants
|
Adverse Events
Following Chemoradiation
Serious events: 40 serious events
Other events: 18 other events
Deaths: 8 deaths
Concurrent to Chemoradiation
Serious events: 27 serious events
Other events: 11 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Following Chemoradiation
n=48 participants at risk
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=46 participants at risk
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
2/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
10.9%
5/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
3/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
2/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
4.3%
2/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
2/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
17.4%
8/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Vomitng
|
6.2%
3/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
8.7%
4/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Immune system disorders
Allergic Reaction
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Infections and infestations
Kidney Infection
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Infections and infestations
Sepsis
|
6.2%
3/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Infections and infestations
Urinary Tract Infection
|
8.3%
4/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Investigations
Neutrophil count decreased
|
4.2%
2/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
3/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
4.2%
2/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Vascular disorders
Thromboembolic event
|
4.2%
2/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
4.3%
2/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
4.3%
2/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
General disorders
Fever
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
General disorders
Flu like symptoms
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
Other adverse events
| Measure |
Following Chemoradiation
n=48 participants at risk
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. After chemoradiation is complete, subjects will receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
Concurrent to Chemoradiation
n=46 participants at risk
Subjects will receive standard chemotherapy weekly and 4-6 fractions of brachytherapy radiation for 5-6 weeks. While subjects are receiving chemotherapy and radiation, they will also receive the study drug, pembrolizumab.
Pembrolizumab: 200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
Brachytherapy: Radiation is done for standard clinical care purposes.
Cisplatin: 40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
|
|---|---|---|
|
General disorders
Chills
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
2/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
General disorders
Fever
|
8.3%
4/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
6.5%
3/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Eye disorders
Blurred Vision
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
6.5%
3/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.2%
2/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Investigations
Creatinine increased
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Investigations
Neutrophil count decreased
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Nervous system disorders
Paresthesia
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
2.2%
1/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
|
Investigations
Platelet count decreased
|
2.1%
1/48 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
0.00%
0/46 • Start of treatment (week 1) through end of treatment visit (35 +/- 5 days following the final treatment).
Adverse experiences will be graded according to NCI CTCAE Version 4.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taken with regard to trial treatment. All adverse events will be reported according per protocol. Throughout the study, investigators should report any deaths, serious adverse events or other adverse events of concern they believe to be related to the investigational agent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place