Trial Outcomes & Findings for Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma (NCT NCT01659151)
NCT ID: NCT01659151
Last Updated: 2025-11-04
Results Overview
Overall response (OR) is defined as the patient being alive at month 12, and tumor size evaluated at screening and at month 12 using the RECIST 1.1 criteria to be a complete response (CR) or partial response (PR). Evaluations will be made by CT scan approximately 12 months from the date of tumor harvest, and by clinical evaluation during the first 12 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
12 Months
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
Combination Therapy
Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).
High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Combination Therapy
Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).
High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.
|
|---|---|
|
Overall Study
Inadequate TIL growth
|
1
|
Baseline Characteristics
Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=17 Participants
Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).
High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.
|
|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=15 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Evaluable participants
Overall response (OR) is defined as the patient being alive at month 12, and tumor size evaluated at screening and at month 12 using the RECIST 1.1 criteria to be a complete response (CR) or partial response (PR). Evaluations will be made by CT scan approximately 12 months from the date of tumor harvest, and by clinical evaluation during the first 12 months
Outcome measures
| Measure |
Combination Therapy
n=16 Participants
Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).
High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.
|
|---|---|
|
Percentage of Participants With Overall Response (OR)
|
38 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Evaluable participants
The percentage of participants who drop out due to progression between the time of harvest and TIL transfer (i.e., the "drop-out rate").
Outcome measures
| Measure |
Combination Therapy
n=16 Participants
Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).
High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.
|
|---|---|
|
Percentage of Participant Drop Out Rate
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Evaluable participants
Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Confidence intervals for the median and survival rates at different time points will be constructed if needed and appropriate. This secondary endpoint will be reported descriptively.
Outcome measures
| Measure |
Combination Therapy
n=16 Participants
Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).
High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.
|
|---|---|
|
Number of Participants With Progression Free Survival (PFS)
|
7 Participants
|
Adverse Events
Combination Therapy
Serious events: 13 serious events
Other events: 17 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Combination Therapy
n=17 participants at risk
Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).
High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.
|
|---|---|
|
Nervous system disorders
Intracranial Hemorrhage
|
11.8%
2/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
29.4%
5/17 • Number of events 10 • 6 months after end of last treatment, an average of 17 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
29.4%
5/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Wound infection
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Death - NOS
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
General disorders and administration site conditions - Other, specify - anasarca
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Immune system disorders
Immune system disorders - Other, specify - guillian barre syndrome
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
Other adverse events
| Measure |
Combination Therapy
n=17 participants at risk
Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).
High Dose Interleukin-2 (IL-2): A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
ACT with TIL Infusion: Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
Vemurafenib: Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
Lymphodepletion: The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more "space" for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion.
|
|---|---|
|
Investigations
Cardiac troponin T increased
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Cholesterol high
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
CPK increased
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Lipase increased
|
5.9%
1/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Urine output decreased
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Weight gain
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Weight loss
|
5.9%
1/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
94.1%
16/17 • Number of events 47 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
88.2%
15/17 • Number of events 38 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
76.5%
13/17 • Number of events 30 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Anorexia
|
70.6%
12/17 • Number of events 21 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
64.7%
11/17 • Number of events 30 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
41.2%
7/17 • Number of events 12 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.3%
6/17 • Number of events 9 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.5%
4/17 • Number of events 9 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.6%
3/17 • Number of events 7 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.6%
3/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
11.8%
2/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
82.4%
14/17 • Number of events 18 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
76.5%
13/17 • Number of events 38 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
64.7%
11/17 • Number of events 30 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.9%
9/17 • Number of events 13 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
52.9%
9/17 • Number of events 12 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
41.2%
7/17 • Number of events 11 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
35.3%
6/17 • Number of events 13 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
23.5%
4/17 • Number of events 6 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Blood and lymphatic system disorders
Anemia
|
94.1%
16/17 • Number of events 101 • 6 months after end of last treatment, an average of 17 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
82.4%
14/17 • Number of events 15 • 6 months after end of last treatment, an average of 17 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
82.4%
14/17 • Number of events 42 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
35.3%
6/17 • Number of events 8 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
29.4%
5/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.5%
4/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
17.6%
3/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Headache
|
88.2%
15/17 • Number of events 32 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Dizziness
|
29.4%
5/17 • Number of events 9 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Dysgeusia
|
29.4%
5/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Presyncope
|
17.6%
3/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
11.8%
2/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
11.8%
2/17 • Number of events 6 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Paresthesia
|
11.8%
2/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Cognitive disturbance
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Dysarthria
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Hypersomnia
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Sinus pain
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Nervous system disorders
Vasovagal reaction
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
52.9%
9/17 • Number of events 16 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
47.1%
8/17 • Number of events 17 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
35.3%
6/17 • Number of events 7 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.6%
3/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
17.6%
3/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.8%
2/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Cardiac disorders
Sinus tachycardia
|
76.5%
13/17 • Number of events 21 • 6 months after end of last treatment, an average of 17 months
|
|
Cardiac disorders
Palpitations
|
29.4%
5/17 • Number of events 8 • 6 months after end of last treatment, an average of 17 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
29.4%
5/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Upper respiratory infection
|
23.5%
4/17 • Number of events 6 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Urinary tract infection
|
17.6%
3/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Papulopustular rash
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Sinusitis
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Skin infection
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Wound infection
|
11.8%
2/17 • Number of events 9 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Eye infection
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Lung infection
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Mucosal infection
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Salivary gland infection
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Infections and infestations
Vaginal infection
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Blurred vision
|
41.2%
7/17 • Number of events 9 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Eye disorders - Other, specify
|
29.4%
5/17 • Number of events 6 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Photophobia
|
17.6%
3/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Conjunctivitis
|
11.8%
2/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Dry eye
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Floaters
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Uveitis
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Eye pain
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Eye disorders
Flashing lights
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Vascular disorders
Capillary leak syndrome
|
35.3%
6/17 • Number of events 6 • 6 months after end of last treatment, an average of 17 months
|
|
Vascular disorders
Hypertension
|
35.3%
6/17 • Number of events 7 • 6 months after end of last treatment, an average of 17 months
|
|
Vascular disorders
Hypotension
|
29.4%
5/17 • Number of events 6 • 6 months after end of last treatment, an average of 17 months
|
|
Vascular disorders
Hot flashes
|
23.5%
4/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Vascular disorders
Flushing
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Psychiatric disorders
Insomnia
|
41.2%
7/17 • Number of events 9 • 6 months after end of last treatment, an average of 17 months
|
|
Psychiatric disorders
Anxiety
|
29.4%
5/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Psychiatric disorders
Delirium
|
11.8%
2/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Psychiatric disorders
Depression
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Psychiatric disorders
Agitation
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Psychiatric disorders
Hallucinations
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
29.4%
5/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
23.5%
4/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Injury, poisoning and procedural complications
Seroma
|
23.5%
4/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Injury, poisoning and procedural complications
Bruising
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Injury, poisoning and procedural complications
Arterial injury
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
29.4%
5/17 • Number of events 11 • 6 months after end of last treatment, an average of 17 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
23.5%
4/17 • Number of events 15 • 6 months after end of last treatment, an average of 17 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
17.6%
3/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Ear and labyrinth disorders
Ear pain
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Ear and labyrinth disorders
Tinnitus
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Renal and urinary disorders
Urinary frequency
|
23.5%
4/17 • Number of events 4 • 6 months after end of last treatment, an average of 17 months
|
|
Renal and urinary disorders
Hematuria
|
17.6%
3/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Renal and urinary disorders
Renal calculi
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Renal and urinary disorders
Renal colic
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Renal and urinary disorders
Urinary tract pain
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
23.5%
4/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Immune system disorders
Allergic reaction
|
5.9%
1/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Immune system disorders
Cytokine release syndrome
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Reproductive system and breast disorders
Breast pain
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Endocrine disorders
Adrenal insufficiency
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Social circumstances
Menopause
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Blood bilirubin increased
|
29.4%
5/17 • Number of events 18 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Creatinine increased
|
29.4%
5/17 • Number of events 7 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Lymphocyte count increased
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Nausea
|
94.1%
16/17 • Number of events 45 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Vomiting
|
64.7%
11/17 • Number of events 25 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
10/17 • Number of events 22 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Constipation
|
35.3%
6/17 • Number of events 11 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
35.3%
6/17 • Number of events 6 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Mucositis oral
|
29.4%
5/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Abdominal pain
|
23.5%
4/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Dry Mouth
|
23.5%
4/17 • Number of events 6 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
17.6%
3/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Bloating
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Flatulence
|
11.8%
2/17 • Number of events 2 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Dental caries
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Chills
|
94.1%
16/17 • Number of events 25 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Fatigue
|
94.1%
16/17 • Number of events 40 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
47.1%
8/17 • Number of events 11 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Pain
|
47.1%
8/17 • Number of events 13 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Edema Limbs
|
41.2%
7/17 • Number of events 11 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Non-cardiac chest pain
|
35.3%
6/17 • Number of events 11 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Localized edema
|
29.4%
5/17 • Number of events 5 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Fever
|
23.5%
4/17 • Number of events 11 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Flu like symptoms
|
17.6%
3/17 • Number of events 3 • 6 months after end of last treatment, an average of 17 months
|
|
General disorders
Malaise
|
5.9%
1/17 • Number of events 1 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Lymphocyte count decreased
|
94.1%
16/17 • Number of events 108 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Neutrophil count decreased
|
94.1%
16/17 • Number of events 47 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Platelet count decreased
|
94.1%
16/17 • Number of events 81 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
White blood cell decreased
|
88.2%
15/17 • Number of events 78 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Alanine aminotransferase increased
|
70.6%
12/17 • Number of events 36 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Alkaline phosphatase increased
|
70.6%
12/17 • Number of events 36 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Aspartate aminotransferase increased
|
58.8%
10/17 • Number of events 19 • 6 months after end of last treatment, an average of 17 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
41.2%
7/17 • Number of events 15 • 6 months after end of last treatment, an average of 17 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place